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African swine fever (ASF) is a contagious disease of wild boar and domestic pigs notifiable to the World Organisation for Animal Health due to its high socio-economic impact. ASF is caused by the complex ASF virus (ASFV), and it can present different clinical manifestations that can be confused with other diseases; for this reason, laboratory testing is necessary for the proper diagnosis of clinically suspected animals. Despite the efforts put into it over decades, no treatment or safe vaccine is globally available, and disease control is based on early diagnosis and the implementation of strict biosecurity measures. In this context, rapid tests have the potential to accelerate and facilitate the identification of infected animals by giving fast on-site results. In this work, we improved the available point-of-care assays for the diagnosis of the disease by the development of a more specific antigen test and a more sensitive antibody test. This antibody detection test allowed for the earlier detection of infected animals than two commercial indirect ELISAs (statistically significant). Moreover, we developed a combined dual rapid test, unifying, in the same cassette, an antigen detection strip and an antibody detection strip. In this study, we confirmed that this combo approach is a useful tool for implementing rapid tests in the field since it increases the percentage of positive samples detected, even when PCR turns negative, while maintaining a good specificity.

Back ground: This study used Toxoplasma IgG/IgM Antibody Rapid test to detect Toxoplasmosis in pregnant women and evaluate their lipid profile compared to a healthy control group. The aim of the study: Serodiagnosis of parasite infection in aborted pregnant women using the rapid detection method. Evaluating the level of some immunological parameters in infected women such as IL17-A, TNA-, lactoferrin, shedding light on the lipid profile of parasite-infected women. Patients and Methods: blood samples 240 were collected from aborted pregnant women attending some governmental hospitals and private medical clinics in some areas of Salah al-Din Governorate during the period from 1/7/2022 to 1/2/2023 and the required information was recorded according to a special questionnaire form. The results: were analyzed statistically using the IBM SPSS Statistics (version 23) program, according to the t-test, at a significant level of p≤0.05. The results of Rapid Test (93 positive samples) 38.7% (divided into 80) 86.02% (positive samples for IgG, while 13 sample) 13.97% (positive for IgM and 147 negative samples) 61.25%. (There is a positive correlation between (LTF, IL-17A, TNF-a) (highly significant). The lipid profile analysis revealed a non-significant increase for each of cholesterol and high-density lipoprotein (HDL) in infected women, as Mean ± S.E concentration was (168.4±8.2 Pg/ml); (33±1.5pg/ml) respectively, compared to the control group, where the Mean ± S.E concentration was (141.6±15.5 Pg/ml); (28±3.09Pg/ml) respectively. While there was a non-significant decrease in each of LDL, very low-density lipoprotein (VLDL), and triglycerides in pateints group, as Mean ± S.E concentration was (80.6±3.7pg/ml); (45.4±1.07 pg/ml); (159.7±4 pg/ml), respectively, compared to the control group, where the average concentration was (84.3±5.3pg/ml); (48.6±2pg/ml) 161.3±6.7pg/ml) respectively.

Back ground: This study used Toxoplasma IgG/IgM Antibody Rapid test to detect Toxoplasmosis in pregnant women and evaluate their lipid profile compared to a healthy control group. The aim of the study: Serodiagnosis of parasite infection in aborted pregnant women using the rapid detection method. Evaluating the level of some immunological parameters in infected women such as IL17-A, TNA-, lactoferrin, shedding light on the lipid profile of parasite-infected women. Patients and Methods: blood samples 240 were collected from aborted pregnant women attending some governmental hospitals and private medical clinics in some areas of Salah al-Din Governorate during the period from 1/7/2022 to 1/2/2023 and the required information was recorded according to a special questionnaire form. The results: were analyzed statistically using the IBM SPSS Statistics (version 23) program, according to the t-test, at a significant level of p≤0.05. The results of Rapid Test (93 positive samples) 38.7% (divided into 80) 86.02% (positive samples for IgG, while 13 sample) 13.97% (positive for IgM and 147 negative samples) 61.25%. (There is a positive correlation between (LTF, IL-17A, TNF-a) (highly significant). The lipid profile analysis revealed a non-significant increase for each of cholesterol and high-density lipoprotein (HDL) in infected women, as Mean ± S.E concentration was (168.4±8.2 Pg/ml); (33±1.5pg/ml) respectively, compared to the control group, where the Mean ± S.E concentration was (141.6±15.5 Pg/ml); (28±3.09Pg/ml) respectively. While there was a non-significant decrease in each of LDL, very low-density lipoprotein (VLDL), and triglycerides in pateints group, as Mean ± S.E concentration was (80.6±3.7pg/ml); (45.4±1.07 pg/ml); (159.7±4 pg/ml), respectively, compared to the control group, where the average concentration was (84.3±5.3pg/ml); (48.6±2pg/ml) 161.3±6.7pg/ml) respectively.

Solid tumor metastases cause most cancer-related deaths. The prevention of their occurrence misses suitable anti-metastases medicines newly labeled as migrastatics. The first indication of migrastatics potential is based on an inhibition of in vitro enhanced migration of tumor cell lines. Therefore, we decided to develop a rapid test for qualifying the expected migrastatic potential of some drugs for repurposing. The chosen Q-PHASE holographic microscope provides reliable multifield time-lapse recording and simultaneous analysis of the cell morphology, migration, and growth. The results of the pilot assessment of the migrastatic potential exerted by the chosen medicines on selected cell lines are presented.

Solid tumor metastases cause most cancer-related deaths. The prevention of their occurrence misses suitable anti-metastases medicines newly labeled as migrastatics. The first indication of migrastatics potential is based on an inhibition of in vitro enhanced migration of tumor cell lines. Therefore, we decided to develop a rapid test for qualifying the expected migrastatic potential of some drugs for repurposing. The chosen Q-PHASE holographic microscope provides reliable multifield time-lapse recording and simultaneous analysis of the cell morphology, migration, and growth. The results of the pilot assessment of the migrastatic potential exerted by the chosen medicines on selected cell lines are presented.

Solid tumor metastases cause most cancer-related deaths. The prevention of their occurrence misses suitable anti-metastases medicines newly labeled as migrastatics. The first indication of migrastatics potential is based on an inhibition of in vitro enhanced migration of tumor cell lines. Therefore, we decided to develop a rapid test for qualifying the expected migrastatic potential of some drugs for repurposing. The chosen Q-PHASE holographic microscope provides reliable multifield time-lapse recording and simultaneous analysis of the cell morphology, migration, and growth. The results of the pilot assessment of the migrastatic potential exerted by the chosen medicines on selected cell lines are presented.

Solid tumor metastases cause most cancer-related deaths. The prevention of their occurrence misses suitable anti-metastases medicines newly labeled as migrastatics. The first indication of migrastatics potential is based on an inhibition of in vitro enhanced migration of tumor cell lines. Therefore, we decided to develop a rapid test for qualifying the expected migrastatic potential of some drugs for repurposing. The chosen Q-PHASE holographic microscope provides reliable multifield time-lapse recording and simultaneous analysis of the cell morphology, migration, and growth. The results of the pilot assessment of the migrastatic potential exerted by the chosen medicines on selected cell lines are presented.

Solid tumor metastases cause most cancer-related deaths. The prevention of their occurrence misses suitable anti-metastases medicines newly labeled as migrastatics. The first indication of migrastatics potential is based on an inhibition of in vitro enhanced migration of tumor cell lines. Therefore, we decided to develop a rapid test for qualifying the expected migrastatic potential of some drugs for repurposing. The chosen Q-PHASE holographic microscope provides reliable multifield time-lapse recording and simultaneous analysis of the cell morphology, migration, and growth. The results of the pilot assessment of the migrastatic potential exerted by the chosen medicines on selected cell lines are presented.

Background: Molecular and antigen point-of-care tests (POCTs) have augmented our ability to rapidly identify and manage SARS-CoV-2 infection. However, their clinical performance varies among individual studies. Objectives: The evaluation of the performance of molecular and antigen-based POCTs in confirmed, suspected, or probable COVID-19 cases compared with that of laboratory-based RT-PCR in real-life settings. Data sources: MEDLINE/PubMed, Scopus, Embase, Web of Science, Cochrane Library, Cochrane COVID-19 study register, and COVID-19 Living Evidence Database from the University of Bern. Study eligibility criteria: Peer-reviewed or preprint observational studies or randomized controlled trials that evaluated any type of commercially available antigen and/or molecular POCTs for SARS-CoV-2, including multiplex PCR panels, approved by the United States Food and Drug Administration, with Emergency Use Authorization, and/or marked with Conformitè Europëenne from European Commission/European Union. Participants: Close contacts and/or patients with symptomatic and/or asymptomatic confirmed, suspected, or probable COVID-19 infection of any age. Test/s: Molecular and/or antigen-based SARS-CoV-2 POCTs. Reference standard: Laboratory-based SARS-CoV-2 RT-PCR. Assessment of risk of bias: Eligible studies were subjected to quality-control and risk-of-bias assessment using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. Methods of data synthesis: Summary sensitivities and specificities with their 95% CIs were estimated using a bivariate model. Subgroup analysis was performed when at least three studies informed the outcome. Results: A total of 123 eligible publications (97 and 26 studies assessing antigen-based and molecular POCTs, respectively) were retrieved from 4674 initial records. The pooled sensitivity and specificity for 13 molecular-based POCTs were 92.8% (95% CI, 88.9–95.4%) and 97.6% (95% CI, 96.6–98.3%), respectively. The sensitivity of antigen-based P

At-home diagnostic tests are extremely useful for rural testing, providing point-of-care detection of harmful pathogens without requiring extensive time, effort, and money to bring the samples back to the lab bench. These tests, commonly called rapid antigen tests but more precisely under the category of lateral flow assays (LFAs), hold exciting potential for the future of accessible healthcare. The research presented in this document has focused on the development of a protocol for the detection of liquid-borne pathogens using paper microfluidics and a smartphone-based fluorescence microscope. This work was first published for the detection of norovirus from wastewater samples and achieved high sensitivity using the particulometry method, or the direct counting of immunoagglutination using anti-norovirus antibodies conjugated to fluorescent particles. This protocol was then further developed for the detection of SARS-CoV-2 from clinical mouthwash samples. Using the same samples, the next work explored a novel technique for indirect measurement of virus presence using the flow behavior of the liquid through the paper channel. Finally, in a progression from antibody-antigen immunoassays, the next project worked to detect perfluorooctanoic acid (PFOA) using the flow rate profile and pre-loaded reagents. With the potential of increasing general education and accessibility of diagnostic healthcare, collectively these investigations contribute to the development of rapid and low-cost diagnostic tools for at-home and point of care use.

The rapid diagnosis of cholera contributes to adequate outbreak management. This meta-analysis assesses the diagnostic accuracy of cholera rapid tests (RDTs) to detect Vibrio cholerae O1. Methods: Systematic review and meta-analysis. We searched four databases (Medline, EMBASE, Google Scholar, and Web of Science up to 8 September 2021) for studies that evaluated cholera RDTs for the detection of V. cholerae O1 compared with either stool culture or polymerase chain reaction (PCR). We assessed the studies' quality using the QUADAS-2 criteria. In addition, in this update, GRADE approach was used to rate the overall certainty of the evidence. We performed a bivariate random-effects meta-analysis to calculate the pooled sensitivity and specificity of cholera RDTs. Results: Overall, 20 studies were included in this meta-analysis. Studies were from Africa (n = 11), Asia (n = 7), and America (Haiti; n = 2). They evaluated eight RDTs (Crystal VC-O1, Crystal VC, Cholkit, Institut Pasteur cholera dipstick, SD Bioline, Artron, Cholera Smart O1, and Smart II Cholera O1). Using direct specimen testing, sensitivity and specificity of RDTs were 90% (95% CI, 86 to 93) and 86% (95% CI, 81 to 90), respectively. Cholera Sensitivity was higher in studies conducted in Africa [92% (95% CI, 89 to 94)] compared with Asia [82% (95% CI, 77 to 87)]. However, specificity [83% (95% CI, 71 to 91)] was lower in Africa compared with Asia [90% (95% CI, 84 to 94)]. GRADE quality of evidence was estimated as moderate. Conclusions: Against culture or PCR, current cholera RDTs have moderate sensitivity and specificity for detecting Vibrio cholerae O1.

The rapid diagnosis of cholera contributes to adequate outbreak management. This meta-analysis assesses the diagnostic accuracy of cholera rapid tests (RDTs) to detect Vibrio cholerae O1. Methods: Systematic review and meta-analysis. We searched four databases (Medline, EMBASE, Google Scholar, and Web of Science up to 8 September 2021) for studies that evaluated cholera RDTs for the detection of V. cholerae O1 compared with either stool culture or polymerase chain reaction (PCR). We assessed the studies' quality using the QUADAS-2 criteria. In addition, in this update, GRADE approach was used to rate the overall certainty of the evidence. We performed a bivariate random-effects meta-analysis to calculate the pooled sensitivity and specificity of cholera RDTs. Results: Overall, 20 studies were included in this meta-analysis. Studies were from Africa (n = 11), Asia (n = 7), and America (Haiti; n = 2). They evaluated eight RDTs (Crystal VC-O1, Crystal VC, Cholkit, Institut Pasteur cholera dipstick, SD Bioline, Artron, Cholera Smart O1, and Smart II Cholera O1). Using direct specimen testing, sensitivity and specificity of RDTs were 90% (95% CI, 86 to 93) and 86% (95% CI, 81 to 90), respectively. Cholera Sensitivity was higher in studies conducted in Africa [92% (95% CI, 89 to 94)] compared with Asia [82% (95% CI, 77 to 87)]. However, specificity [83% (95% CI, 71 to 91)] was lower in Africa compared with Asia [90% (95% CI, 84 to 94)]. GRADE quality of evidence was estimated as moderate. Conclusions: Against culture or PCR, current cholera RDTs have moderate sensitivity and specificity for detecting Vibrio cholerae O1.

Following the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, numerous serological tests have been developed, including rapid diagnostic tests. This study aims at assessing the clinical performance of the Panbio immunoglobulin G (IgG)/IgM coronavirus disease 2019 (COVID-19) test (Abbott), a rapid lateral flow assay for the qualitative detection of IgG and IgM against SARS-CoV-2. One hundred and thirty-eight samples from 95 COVID-19 patients with a positive SARS-CoV-2 reverse-transcriptase polymerase chain reaction were analyzed to assess the clinical sensitivity. Seventy-six pre-COVID-19 samples were used to evaluate the clinical specificity. Two independent and blinded raters determined visually the presence or absence of the IgG, IgM, and control lines for each test after 10 and 20 min. The sensitivity obtained from collected samples more than 14 days after the onset of symptoms was 95.2% for IgG. IgM was less frequently detected (highest sensitivity of 20.5%). The specificities obtained were 98.7% and 100% for IgG and IgM, respectively. In addition, the sensitivity of the assay was better when the reading was performed at 20 min than at 10 min, whereas the specificity was unchanged. The Panbio COVID-19 IgG/IgM rapid test detects IgG with high sensitivity 14 days since symptom onset but presents a low sensitivity for IgM. The specificity was excellent for both IgG and IgM., SCOPUS: ar.j, info:eu-repo/semantics/published

COVID-19 is the most rapidly growing pandemic in modern time, and the need for 21 serological testing is most urgent. Although the diagnostics of acute patients by RT-PCR is 22 both efficient and specific, we are also crucially in need of serological tools for investigating 23 antibody responses and assessing individual and potential herd immunity. We evaluated a 24 commercially available test developed for rapid (within 15 minutes) detection of SARS-CoV-25 2-specific IgM and IgG by 29 PCR-confirmed COVID-19 cases and 124 negative controls. 26 The results revealed a sensitivity of 69.0 % and 93.1 % for IgM and IgG, respectively, based 27 solely on PCR-positivity due to the absence of a serological gold standard. The assay 28 specificities were shown to be 100 % for IgM and 99.2 % for IgG. This indicates that the test 29 is suitable for assessing previous virus exposure, although negative results may be unreliable 30 during the first weeks after infection. More detailed studies on antibody responses during and 31 post infection are urgently needed.

COVID-19 is the most rapidly growing pandemic in modern time, and the need for 21 serological testing is most urgent. Although the diagnostics of acute patients by RT-PCR is 22 both efficient and specific, we are also crucially in need of serological tools for investigating 23 antibody responses and assessing individual and potential herd immunity. We evaluated a 24 commercially available test developed for rapid (within 15 minutes) detection of SARS-CoV-25 2-specific IgM and IgG by 29 PCR-confirmed COVID-19 cases and 124 negative controls. 26 The results revealed a sensitivity of 69.0 % and 93.1 % for IgM and IgG, respectively, based 27 solely on PCR-positivity due to the absence of a serological gold standard. The assay 28 specificities were shown to be 100 % for IgM and 99.2 % for IgG. This indicates that the test 29 is suitable for assessing previous virus exposure, although negative results may be unreliable 30 during the first weeks after infection. More detailed studies on antibody responses during and 31 post infection are urgently needed.

COVID-19 is the most rapidly growing pandemic in modern time, and the need for 21 serological testing is most urgent. Although the diagnostics of acute patients by RT-PCR is 22 both efficient and specific, we are also crucially in need of serological tools for investigating 23 antibody responses and assessing individual and potential herd immunity. We evaluated a 24 commercially available test developed for rapid (within 15 minutes) detection of SARS-CoV-25 2-specific IgM and IgG by 29 PCR-confirmed COVID-19 cases and 124 negative controls. 26 The results revealed a sensitivity of 69.0 % and 93.1 % for IgM and IgG, respectively, based 27 solely on PCR-positivity due to the absence of a serological gold standard. The assay 28 specificities were shown to be 100 % for IgM and 99.2 % for IgG. This indicates that the test 29 is suitable for assessing previous virus exposure, although negative results may be unreliable 30 during the first weeks after infection. More detailed studies on antibody responses during and 31 post infection are urgently needed.

Objectives: To describe the first isolation and sequencing of SARS-CoV-2 in Australia and rapid sharing of the isolate. Setting(s): SARS-CoV-2 was isolated from a 58-year-old man from Wuhan, China who arrived in Melbourne on 19 January 2020 and was admitted to the Monash Medical Centre, Melbourne from the emergency department on 24 January 2020 with fever, cough, and progressive dyspnoea. Major outcomes: Clinical course and laboratory features of the first reported case of COVID-19 (the illness caused by SARS-CoV-2) in Australia; isolation, whole genome sequencing, imaging, and rapid sharing of virus from the patient. Result(s): A nasopharyngeal swab and sputum collected when the patient presented to hospital were each positive for SARS-CoV-2 (reverse transcription polymerase chain reaction). Inoculation of Vero/hSLAM cells with material from the nasopharyngeal swab led to the isolation of SARS-CoV-2 virus in culture. Electron microscopy of the supernatant confirmed the presence of virus particles with morphology characteristic of viruses of the family Coronaviridae. Whole genome sequencing of the viral isolate and phylogenetic analysis indicated the isolate exhibited greater than 99.99% sequence identity with other publicly available SARS-CoV-2 genomes. Within 24 hours of isolation, the first Australian SARS-CoV-2 isolate was shared with local and overseas reference laboratories and major North American and European culture collections. Conclusion(s): The ability to rapidly identify, propagate, and internationally share our SARS-CoV-2 isolate is an important step in collaborative scientific efforts to deal effectively with this international public health emergency by developing better diagnostic procedures, vaccine candidates, and antiviral agents.Copyright © 2020 AMPCo Pty Ltd

Background: Rapid genomic sequencing with results available in clinically meaningful timeframes is becoming feasible. Its role in the diagnosis and management of patients with kidney disease is unclear. Method(s): Patients were recruited prospectively for rapid whole exome sequencing (WES) with analysis of a pre-determined phenotype specific list of genes of interest and results available in less than 2 weeks. This followed review by a nephrologist, clinical geneticist and genetic counsellor who considered inclusion if a result was likely to significantly impact clinical management, particularly avoiding kidney biopsies in younger children. Full author list online at KidGen.org.au Results: Ten patients (7 pediatric, 5 female) were recruited ranging in age from 1 month to 55 years. Indications for rapid testing were to avoid a renal biopsy (8) and to facilitate transplant planning (2). Five patients received a definitive diagnosis (ADPKD, Dent disease, primary hyperoxaluria, Alport syndrome and ciliopathy), 1 received a diagnosis which was likely unrelated to their kidney disease (MIRAGE syndrome). One patient's negative result facilitated sibling donor workup. The most significant result in this cohort was an unexpected diagnosis of primary hyperoxaluria in a 6-month old presenting in renal failure. WES results were available within 5 days informing conversion from peritoneal dialysis to hemodialysis and planning for a sequential liver-kidney transplant. This avoided the significant morbidity of oxalate deposition in extra-renal tissues leading to fractures, visual impairment and heart failure and recurrence of the disease if an isolated renal transplant had been performed. Conclusion(s): Rapid genomic sequencing has high diagnostic utility in selected patients with renal disease and can inform clinical management within meaningful timeframes. It has the potential to transform the diagnostic pathway for young children, particularly where invasive renal biopsies can

Objectives: To describe the first isolation and sequencing of SARS-CoV-2 in Australia and rapid sharing of the isolate. Setting(s): SARS-CoV-2 was isolated from a 58-year-old man from Wuhan, China who arrived in Melbourne on 19 January 2020 and was admitted to the Monash Medical Centre, Melbourne from the emergency department on 24 January 2020 with fever, cough, and progressive dyspnoea. Major outcomes: Clinical course and laboratory features of the first reported case of COVID-19 (the illness caused by SARS-CoV-2) in Australia; isolation, whole genome sequencing, imaging, and rapid sharing of virus from the patient. Result(s): A nasopharyngeal swab and sputum collected when the patient presented to hospital were each positive for SARS-CoV-2 (reverse transcription polymerase chain reaction). Inoculation of Vero/hSLAM cells with material from the nasopharyngeal swab led to the isolation of SARS-CoV-2 virus in culture. Electron microscopy of the supernatant confirmed the presence of virus particles with morphology characteristic of viruses of the family Coronaviridae. Whole genome sequencing of the viral isolate and phylogenetic analysis indicated the isolate exhibited greater than 99.99% sequence identity with other publicly available SARS-CoV-2 genomes. Within 24 hours of isolation, the first Australian SARS-CoV-2 isolate was shared with local and overseas reference laboratories and major North American and European culture collections. Conclusion(s): The ability to rapidly identify, propagate, and internationally share our SARS-CoV-2 isolate is an important step in collaborative scientific efforts to deal effectively with this international public health emergency by developing better diagnostic procedures, vaccine candidates, and antiviral agents.Copyright © 2020 AMPCo Pty Ltd

Background: Rapid genomic sequencing with results available in clinically meaningful timeframes is becoming feasible. Its role in the diagnosis and management of patients with kidney disease is unclear. Method(s): Patients were recruited prospectively for rapid whole exome sequencing (WES) with analysis of a pre-determined phenotype specific list of genes of interest and results available in less than 2 weeks. This followed review by a nephrologist, clinical geneticist and genetic counsellor who considered inclusion if a result was likely to significantly impact clinical management, particularly avoiding kidney biopsies in younger children. Full author list online at KidGen.org.au Results: Ten patients (7 pediatric, 5 female) were recruited ranging in age from 1 month to 55 years. Indications for rapid testing were to avoid a renal biopsy (8) and to facilitate transplant planning (2). Five patients received a definitive diagnosis (ADPKD, Dent disease, primary hyperoxaluria, Alport syndrome and ciliopathy), 1 received a diagnosis which was likely unrelated to their kidney disease (MIRAGE syndrome). One patient's negative result facilitated sibling donor workup. The most significant result in this cohort was an unexpected diagnosis of primary hyperoxaluria in a 6-month old presenting in renal failure. WES results were available within 5 days informing conversion from peritoneal dialysis to hemodialysis and planning for a sequential liver-kidney transplant. This avoided the significant morbidity of oxalate deposition in extra-renal tissues leading to fractures, visual impairment and heart failure and recurrence of the disease if an isolated renal transplant had been performed. Conclusion(s): Rapid genomic sequencing has high diagnostic utility in selected patients with renal disease and can inform clinical management within meaningful timeframes. It has the potential to transform the diagnostic pathway for young children, particularly where invasive renal biopsies can

The COVID-19 pandemic is growing and spread in the Swedish elderly care system during April 2020. The increasing number of employees on sick-leave due to COVID-19 created severe logistic problems. Some elderly care homes therefore started to screen their personnel to secure the safety of the elderly and to avoid unnecessary quarantine of potentially immune employees. Secondary data from a screening with a COVID-19 rapid test for detection of SARS-CoV-2-specific IgM and IgG of 1,005 employees in 22 elderly care homes in Stockholm, Sweden, were analyzed. Seropositive employees were found in 21 out of the 22 care homes. In total, 23% (231/1,005) of the employees tested positive for antibodies against SARS-CoV-2, and 14.3% (144/1,005) were found positive for IgM (either alone or combined with IgG), indicating recent or present infection. Of those that tested seropositive, 46.5% did not report any clinical symptoms, indicating pre- or asymptomatic infections. Reported symptoms with the highest correlation with seropositivity were fever and loss of smell and taste. These results suggest that antibody testing of employees in elderly care homes is valuable for surveillance of disease development and a crucial screening tool in the effort to decrease the death toll in this pandemic.

The COVID-19 pandemic is growing and spread in the Swedish elderly care system during April 2020. The increasing number of employees on sick-leave due to COVID-19 created severe logistic problems. Some elderly care homes therefore started to screen their personnel to secure the safety of the elderly and to avoid unnecessary quarantine of potentially immune employees. Secondary data from a screening with a COVID-19 rapid test for detection of SARS-CoV-2-specific IgM and IgG of 1,005 employees in 22 elderly care homes in Stockholm, Sweden, were analyzed. Seropositive employees were found in 21 out of the 22 care homes. In total, 23% (231/1,005) of the employees tested positive for antibodies against SARS-CoV-2, and 14.3% (144/1,005) were found positive for IgM (either alone or combined with IgG), indicating recent or present infection. Of those that tested seropositive, 46.5% did not report any clinical symptoms, indicating pre- or asymptomatic infections. Reported symptoms with the highest correlation with seropositivity were fever and loss of smell and taste. These results suggest that antibody testing of employees in elderly care homes is valuable for surveillance of disease development and a crucial screening tool in the effort to decrease the death toll in this pandemic.

The COVID-19 pandemic is growing and spread in the Swedish elderly care system during April 2020. The increasing number of employees on sick-leave due to COVID-19 created severe logistic problems. Some elderly care homes therefore started to screen their personnel to secure the safety of the elderly and to avoid unnecessary quarantine of potentially immune employees. Secondary data from a screening with a COVID-19 rapid test for detection of SARS-CoV-2-specific IgM and IgG of 1,005 employees in 22 elderly care homes in Stockholm, Sweden, were analyzed. Seropositive employees were found in 21 out of the 22 care homes. In total, 23% (231/1,005) of the employees tested positive for antibodies against SARS-CoV-2, and 14.3% (144/1,005) were found positive for IgM (either alone or combined with IgG), indicating recent or present infection. Of those that tested seropositive, 46.5% did not report any clinical symptoms, indicating pre- or asymptomatic infections. Reported symptoms with the highest correlation with seropositivity were fever and loss of smell and taste. These results suggest that antibody testing of employees in elderly care homes is valuable for surveillance of disease development and a crucial screening tool in the effort to decrease the death toll in this pandemic.

The COVID-19 pandemic is growing and spread in the Swedish elderly care system during April 2020. The increasing number of employees on sick-leave due to COVID-19 created severe logistic problems. Some elderly care homes therefore started to screen their personnel to secure the safety of the elderly and to avoid unnecessary quarantine of potentially immune employees. Secondary data from a screening with a COVID-19 rapid test for detection of SARS-CoV-2-specific IgM and IgG of 1,005 employees in 22 elderly care homes in Stockholm, Sweden, were analyzed. Seropositive employees were found in 21 out of the 22 care homes. In total, 23% (231/1,005) of the employees tested positive for antibodies against SARS-CoV-2, and 14.3% (144/1,005) were found positive for IgM (either alone or combined with IgG), indicating recent or present infection. Of those that tested seropositive, 46.5% did not report any clinical symptoms, indicating pre- or asymptomatic infections. Reported symptoms with the highest correlation with seropositivity were fever and loss of smell and taste. These results suggest that antibody testing of employees in elderly care homes is valuable for surveillance of disease development and a crucial screening tool in the effort to decrease the death toll in this pandemic.

COVID-19 is the most rapidly growing pandemic in modern time, and the need for 21 serological testing is most urgent. Although the diagnostics of acute patients by RT-PCR is 22 both efficient and specific, we are also crucially in need of serological tools for investigating 23 antibody responses and assessing individual and potential herd immunity. We evaluated a 24 commercially available test developed for rapid (within 15 minutes) detection of SARS-CoV-25 2-specific IgM and IgG by 29 PCR-confirmed COVID-19 cases and 124 negative controls. 26 The results revealed a sensitivity of 69.0 % and 93.1 % for IgM and IgG, respectively, based 27 solely on PCR-positivity due to the absence of a serological gold standard. The assay 28 specificities were shown to be 100 % for IgM and 99.2 % for IgG. This indicates that the test 29 is suitable for assessing previous virus exposure, although negative results may be unreliable 30 during the first weeks after infection. More detailed studies on antibody responses during and 31 post infection are urgently needed.

The COVID-19 pandemic is growing and spread in the Swedish elderly care system during April 2020. The increasing number of employees on sick-leave due to COVID-19 created severe logistic problems. Some elderly care homes therefore started to screen their personnel to secure the safety of the elderly and to avoid unnecessary quarantine of potentially immune employees. Secondary data from a screening with a COVID-19 rapid test for detection of SARS-CoV-2-specific IgM and IgG of 1,005 employees in 22 elderly care homes in Stockholm, Sweden, were analyzed. Seropositive employees were found in 21 out of the 22 care homes. In total, 23% (231/1,005) of the employees tested positive for antibodies against SARS-CoV-2, and 14.3% (144/1,005) were found positive for IgM (either alone or combined with IgG), indicating recent or present infection. Of those that tested seropositive, 46.5% did not report any clinical symptoms, indicating pre- or asymptomatic infections. Reported symptoms with the highest correlation with seropositivity were fever and loss of smell and taste. These results suggest that antibody testing of employees in elderly care homes is valuable for surveillance of disease development and a crucial screening tool in the effort to decrease the death toll in this pandemic.

COVID-19 is the most rapidly growing pandemic in modern time, and the need for 21 serological testing is most urgent. Although the diagnostics of acute patients by RT-PCR is 22 both efficient and specific, we are also crucially in need of serological tools for investigating 23 antibody responses and assessing individual and potential herd immunity. We evaluated a 24 commercially available test developed for rapid (within 15 minutes) detection of SARS-CoV-25 2-specific IgM and IgG by 29 PCR-confirmed COVID-19 cases and 124 negative controls. 26 The results revealed a sensitivity of 69.0 % and 93.1 % for IgM and IgG, respectively, based 27 solely on PCR-positivity due to the absence of a serological gold standard. The assay 28 specificities were shown to be 100 % for IgM and 99.2 % for IgG. This indicates that the test 29 is suitable for assessing previous virus exposure, although negative results may be unreliable 30 during the first weeks after infection. More detailed studies on antibody responses during and 31 post infection are urgently needed.

Purpose: The purpose of the study was to implement and prospectively evaluate the outcomes of a rapid genomic diagnosis program at two pediatric tertiary centers. Method(s): Rapid singleton whole-exome sequencing (rWES) was performed in acutely unwell pediatric patients with suspected monogenic disorders. Laboratory and clinical barriers to implementation were addressed through continuous multidisciplinary review of process parameters. Diagnostic and clinical utility and cost-effectiveness of rWES were assessed. Result(s): Of 40 enrolled patients, 21 (52.5%) received a diagnosis, with median time to report of 16 days (range 9-109 days). A result was provided during the first hospital admission in 28 of 36 inpatients (78%). Clinical management changed in 12 of the 21 diagnosed patients (57%), including the provision of lifesaving treatment, avoidance of invasive biopsies, and palliative care guidance. The cost per diagnosis was AU$13,388 (US$10,453). Additional cost savings from avoidance of planned tests and procedures and reduced length of stay are estimated to be around AU$543,178 (US$424,101). The clear relative advantage of rWES, joint clinical and laboratory leadership, and the creation of a multidisciplinary "rapid team" were key to successful implementation. Conclusion(s): Rapid genomic testing in acute pediatrics is not only feasible but also cost-effective, and has high diagnostic and clinical utility. It requires a whole-of-system approach for successful implementation.Copyright © 2018, American College of Medical Genetics and Genomics.

Purpose: The purpose of the study was to implement and prospectively evaluate the outcomes of a rapid genomic diagnosis program at two pediatric tertiary centers. Method(s): Rapid singleton whole-exome sequencing (rWES) was performed in acutely unwell pediatric patients with suspected monogenic disorders. Laboratory and clinical barriers to implementation were addressed through continuous multidisciplinary review of process parameters. Diagnostic and clinical utility and cost-effectiveness of rWES were assessed. Result(s): Of 40 enrolled patients, 21 (52.5%) received a diagnosis, with median time to report of 16 days (range 9-109 days). A result was provided during the first hospital admission in 28 of 36 inpatients (78%). Clinical management changed in 12 of the 21 diagnosed patients (57%), including the provision of lifesaving treatment, avoidance of invasive biopsies, and palliative care guidance. The cost per diagnosis was AU$13,388 (US$10,453). Additional cost savings from avoidance of planned tests and procedures and reduced length of stay are estimated to be around AU$543,178 (US$424,101). The clear relative advantage of rWES, joint clinical and laboratory leadership, and the creation of a multidisciplinary "rapid team" were key to successful implementation. Conclusion(s): Rapid genomic testing in acute pediatrics is not only feasible but also cost-effective, and has high diagnostic and clinical utility. It requires a whole-of-system approach for successful implementation.Copyright © 2018, American College of Medical Genetics and Genomics.

General practitioners would like to use more rapid tests, particularly to help them make decisions about patients with acute heart and lung problems. Unfortunately, there is limited and unconvincing evidence at the moment to suggest that the use of rapid tests by general practitioners would lead to more accurate diagnoses and improved policies for patients with acute heart and lung problems. The Marburg Heart Score, a simple clinical tool, cannot exclude acute heart damage in a referenced population suspected of acute coronary syndrome (oxygen deficiency in the heart). We argue that further research on diagnosing patients with acute heart and lung problems should focus on a strategy that combines a clinical tool with a rapid test.

General practitioners would like to use more rapid tests, particularly to help them make decisions about patients with acute heart and lung problems. Unfortunately, there is limited and unconvincing evidence at the moment to suggest that the use of rapid tests by general practitioners would lead to more accurate diagnoses and improved policies for patients with acute heart and lung problems. The Marburg Heart Score, a simple clinical tool, cannot exclude acute heart damage in a referenced population suspected of acute coronary syndrome (oxygen deficiency in the heart). We argue that further research on diagnosing patients with acute heart and lung problems should focus on a strategy that combines a clinical tool with a rapid test.

__Background:__ Evaluation of the HIV Testing Week (HTW) 2015 in Amsterdam: the number of (positive) tested persons, characteristics and testing history of the tested population, the differences in attendance per location and the healthcare workers’ experiences and opinions concerning the HTW. __Methods:__ The HTW took place from 28 November till 4 December 2015. Anonymous HIV rapid testing (INSTI™ HIV1/HIV2 Ab test or Determine™ HIV-1/2 Ag/Ab test) was offered free of charge at four hospitals, 12 general practitioner (GP) clinics, a sexually transmitted infections (STI) clinic, a laboratory, sites of a community-based organisation, and at outreach locations. Home-based testing (OraQuick® In-Home HIV Test) was offered online. The focus was to motivate two groups to test: men who have sex with men (MSM) and non-Western migrants. Questionnaires regarding participant’s characteristics and HIV testing history were collected. Also healthcare workers were asked to complete a questionnaire evaluating the HTW. __Results:__ In total, 1231 participants were tested. With three positive HIV tests, the detection rate was 0.3% (95%CI 0. 26–0.37). Of all participants, 24.7% (304/1231) were MSM. Respectively, 22.3% (275/1231) and 15.7% (193/1231) were first- and second-generation migrants from a non-Western country. Altogether, 56.7% (698/1231) of participants belonged to one of the targeted risk groups. For 32.7% (402/1231) of participants, it was the first time they received testing, and 35.1% (432/1231) were tested more than 1 year ago. Among MSM 13.2% were tested for the first time, among first- and second-generation non-Western migrants this percentage was significantly higher at 27.2% and 33.5% respectively (p < 0.01). The number of tested participants per location varied widely, especially between GP clinics (range 3–63). Healthcare workers were positive about the HTW: about half (46.2%) stated they would more readily offer an HIV test following their experience with the HTW

BackgroundDual rapid tests for HIV and syphilis infections allow for detection of HIV infection and syphilis at the point-of-care. Those tests have been evaluated in laboratory settings and show excellent performance but have not been evaluated in the field. We evaluated the field performance of the SD BIOLINE HIV/Syphilis Duo test in Port-au-Prince, Haiti using whole blood fingerprick specimens.MethodsGHESKIO (Haitian Study Group for Kaposi's Sarcoma and Opportunistic Infections) clinic attendees 18 years of age or older were invited to participate. Venipuncture blood specimens were used for reference testing with standard commercially available tests for HIV and syphilis in Haiti. The sensitivity and specificity of the Duo test compared to the reference standard were calculated. The exact binomial method was used to determine 95 % confidence intervals (CI).ResultsOf 298 study participants, 237 (79.5 %) were female, of which 49 (20.7 %) were pregnant. For the HIV test component, the sensitivity and specificity were 99.2 % (95 % CI: 95.8 %, 100 %) and 97.0 % (95 % CI: 93.2 %, 99.0 %), respectively; and for the syphilis component were 96.5 % (95 % CI: 91.2 %, 99.0 %) and 90.8 % (95 % CI: 85.7 %, 94.6 %), respectively. In pregnant women, the sensitivity and specificity of the HIV test component were 93.3 % (95 % CI: 68.0 %, 99.8 %) and 94.1 % (95 % CI: 80.3 %, 99.3 %), respectively; and for the syphilis component were 100 % (95 % CI:81.5 %, 100 %) and 96.8 % (95 % CI:83.3 %, 99.9 %), respectively.ConclusionThe Standard Diagnostics BIOLINE HIV/Syphilis Duo dual test performed well in a field setting in Haiti and should be considered for wider use.

Background Clinical signs and symptoms of different airway pathogens are generally indistinguishable, making laboratory tests essential for clinical decisions regarding isolation and antiviral therapy. Immunochromatographic tests (ICT) and direct immunofluorescence assays (DFA) have lower sensitivities and specificities than molecular assays, but have the advantage of quick turnaround times and ease-of-use. Objective To evaluate the performance of a rapid molecular assay, ARIES FluA/B & RSV, using laboratory developed RT-PCR assays (LDA), ICT (BinaxNOW) and DFA. Methods Analytical and clinical performance were evaluated in a retrospective study arm (stored respiratory samples obtained between 2006–2015) and a prospective study arm (unselected fresh clinical samples obtained between December 2015 and March 2016 tested in parallel with LDAs). Results Genotype inclusivity and analytical specificity was 100%. However, ARIES was 0.5 log, 1–2logs and 2.5logs less sensitive for fluA, RSV and fluB respectively, compared to LDA. In total, 447 clinical samples were included, of which 15.4% tested positive for fluA, 9.2% for fluB and 26.0% for RSV, in both LDA and ARIES. ARIES clinical sensitivity compared to LDA was 98.6% (fluA), 93.3% (fluB) and 95.1% (RSV). Clinical specificity was 100% for all

BackgroundDual rapid tests for HIV and syphilis infections allow for detection of HIV infection and syphilis at the point-of-care. Those tests have been evaluated in laboratory settings and show excellent performance but have not been evaluated in the field. We evaluated the field performance of the SD BIOLINE HIV/Syphilis Duo test in Port-au-Prince, Haiti using whole blood fingerprick specimens.MethodsGHESKIO (Haitian Study Group for Kaposi's Sarcoma and Opportunistic Infections) clinic attendees 18 years of age or older were invited to participate. Venipuncture blood specimens were used for reference testing with standard commercially available tests for HIV and syphilis in Haiti. The sensitivity and specificity of the Duo test compared to the reference standard were calculated. The exact binomial method was used to determine 95 % confidence intervals (CI).ResultsOf 298 study participants, 237 (79.5 %) were female, of which 49 (20.7 %) were pregnant. For the HIV test component, the sensitivity and specificity were 99.2 % (95 % CI: 95.8 %, 100 %) and 97.0 % (95 % CI: 93.2 %, 99.0 %), respectively; and for the syphilis component were 96.5 % (95 % CI: 91.2 %, 99.0 %) and 90.8 % (95 % CI: 85.7 %, 94.6 %), respectively. In pregnant women, the sensitivity and specificity of the HIV test component were 93.3 % (95 % CI: 68.0 %, 99.8 %) and 94.1 % (95 % CI: 80.3 %, 99.3 %), respectively; and for the syphilis component were 100 % (95 % CI:81.5 %, 100 %) and 96.8 % (95 % CI:83.3 %, 99.9 %), respectively.ConclusionThe Standard Diagnostics BIOLINE HIV/Syphilis Duo dual test performed well in a field setting in Haiti and should be considered for wider use.

BackgroundIn resource-limited settings, HIV infection is often diagnosed using 2 rapid tests. If the results are discordant, a third tie-breaker test is often used to determine HIV status. This study characterized samples with discordant rapid tests and compared different testing strategies for determining HIV status in these cases.MethodsSamples were previously collected from 173 African adults in a population-based survey who had discordant rapid test results. Samples were classified as HIV positive or HIV negative using a rigorous testing algorithm that included two fourth-generation tests, a discriminatory test, and 2 HIV RNA tests. Tie-breaker tests were evaluated, including rapid tests (1 performed in-country), a third-generation enzyme immunoassay, and two fourth-generation tests. Selected samples were further characterized using additional assays.ResultsTwenty-nine samples (16.8%) were classified as HIV positive and 24 of those samples (82.8%) had undetectable HIV RNA. Antiretroviral drugs were detected in 1 sample. Sensitivity was 8.3%-43% for the rapid tests; 24.1% for the third-generation enzyme immunoassay; 95.8% and 96.6% for the fourth-generation tests. Specificity was lower for the fourth-generation tests than the other tests. Accuracy ranged from 79.5% to 91.3%.ConclusionsIn this population-based survey, most HIV-infected adults with discordant rapid tests were virally suppressed without antiretroviral drugs. Use of individual assays as tie-breaker tests was not a reliable method for determining HIV status in these individuals. More extensive testing algorithms that use a fourth-generation screening test with a discriminatory test and HIV RNA test are preferable for determining HIV status in these cases.

Background: There are no rapid tests that can distinguish contagious gastroenteritis, which requires isolation at its onset, from exacerbation of chronic inflammatory bowel disease (IBD) or bowel engagement in the course of systemic inflammatory response syndrome (SIRS). Hepatocyte growth factor (HGF) is an acute phase cytokine that is produced at the site of injury. It has high affinity to sulfated glycan, and this binding affinity is lost during chronic inflammation. The fecal pH strongly impacts the prognosis for severe bowel disease. We developed a strip test to evaluate HGF as a local acute phase response marker in the bowel. This test assessed the binding affinity of HGF to sulfated glycans in fecal samples and determined fecal pH as an indicator of illness severity. Methods: Fresh feces from patients with diarrhea (n = 513) were collected and tested blindly, and information about patient illness course and outcome was collected. Patients were classified based on the focus of inflammation and the cause of the symptoms. Objectively verified diagnoses of infectious gastroenteritis (n = 131) and IBD onset/exacerbation and bowel cancer (n = 44) were used to estimate the performance of the test strip. ELISA was performed on 101 freeze-thawed feces samples to determine the fecal HGF levels. Results: The test rapidly distinguished infectious gastroenteritis from non-infectious inflammatory causes of diarrhea (sensitivity, 87.96%; specificity, 90.9%; positive predictive value, 96.6%; negative predictive value, 71.4%; accuracy, 89.1%). Fecal pH (p < 0.0001) and mortality within 28 days of sampling (p < 0.04) was higher in patients with sepsis/SIRS and diarrhea. The concentration of HGF was higher in strip test-positive stool samples (p < 0.01). Conclusions: HGF is a good local acute phase response marker of acute bowel inflammation. Test-strip determination of the binding affinity of fecal HGF to sulfated glycan was a rapid, equipment-free way to assess patien, Funding Agency:County Council of Östergotland (ALF-grants)

BackgroundIn the HIV Prevention Trials Network (HPTN) 061 study, 8 (2.3%) of 348 HIV-infected participants identified as HIV uninfected at study enrollment using a single HIV rapid test for screening were found to be HIV infected after additional testing.ObjectivesTo evaluate the performance of different HIV assays for detection of HIV infection in HPTN 061 participants with missed infection and individuals with viral suppression.MethodsPlasma samples from 8 HPTN 061 participants, 17 elite controllers, and 101 individuals on antiretroviral treatment (ART) were tested for HIV with 3 rapid tests, 2 laboratory-based immunoassays, and a Western blot assay. The HPTN 061 samples were also tested with 2 HIV RNA assays and an antiretroviral drug assay.ResultsOf the 8 HPTN 061 participants with missed infection, 1 was an elite controller, 1 was taking ART, 2 were missed because of testing or clerical errors, 1 had recent HIV infection (identified using a multi-assay algorithm), and 3 had acute HIV infection. Two (1.7%) of 118 individuals with viral suppression (both taking ART) had at least 1 false-negative test.ConclusionsIn clinical trials, HIV infections can be missed for a variety of reasons. Using more than one assay to screen for HIV infection may reduce the number of missed infections.

For rapid results, we adapted the CarbaNP test by using 5-hour-old cultures; the sensitivity and specificity for detection of carbapenemase production were 100% for non-OXA-producing organisms. The sensitivity from early cultures was 94% for detection of carbapenemase production in Enterobacteriaceae strains. Utilizing younger cultures allows the test to be incorporated into a single day's workflow, facilitating timely patient care and antimicrobial stewardship.Copyright © 2014, American Society for Microbiology. All Rights Reserved.

For rapid results, we adapted the CarbaNP test by using 5-hour-old cultures; the sensitivity and specificity for detection of carbapenemase production were 100% for non-OXA-producing organisms. The sensitivity from early cultures was 94% for detection of carbapenemase production in Enterobacteriaceae strains. Utilizing younger cultures allows the test to be incorporated into a single day's workflow, facilitating timely patient care and antimicrobial stewardship.Copyright © 2014, American Society for Microbiology. All Rights Reserved.

BackgroundIn the HIV Prevention Trials Network (HPTN) 061 study, 8 (2.3%) of 348 HIV-infected participants identified as HIV uninfected at study enrollment using a single HIV rapid test for screening were found to be HIV infected after additional testing.ObjectivesTo evaluate the performance of different HIV assays for detection of HIV infection in HPTN 061 participants with missed infection and individuals with viral suppression.MethodsPlasma samples from 8 HPTN 061 participants, 17 elite controllers, and 101 individuals on antiretroviral treatment (ART) were tested for HIV with 3 rapid tests, 2 laboratory-based immunoassays, and a Western blot assay. The HPTN 061 samples were also tested with 2 HIV RNA assays and an antiretroviral drug assay.ResultsOf the 8 HPTN 061 participants with missed infection, 1 was an elite controller, 1 was taking ART, 2 were missed because of testing or clerical errors, 1 had recent HIV infection (identified using a multi-assay algorithm), and 3 had acute HIV infection. Two (1.7%) of 118 individuals with viral suppression (both taking ART) had at least 1 false-negative test.ConclusionsIn clinical trials, HIV infections can be missed for a variety of reasons. Using more than one assay to screen for HIV infection may reduce the number of missed infections.

Background Calprotectin is a protein found in the cytoplasm of neutrophile granulocytes. In the course of inflammatory bowel disease (IBD), calprotectin is released during chronic inflammation in the gut. Activation of neutrophils during the inflammation is followed by activation and secretion of pro-inflammatory molecules such as calprotectin. Calprotectin is stable in stool up to 7 days and can therefore be used as a non-invasive marker for diagnosis, treatment and measurement of the disease activity in patients with IBD. The most common method for analysis of calprotectin concentration is ELISA. This method is time-consuming and many manufactures have therefore developed rapid tests as a faster alternative for quantification of calprotectin in stool. Aim The aim of the study was to evaluate one ELISA and one rapid test from the same manufacture compare the data with the existing ELISA-method used in the laboratory for routine analysis. Methods A rapid test (CalFast) and an ELISA method (CalPrest) from Eurospital, were used for analysis of calprotectin in stool. These two methods were compared with known concentrations of calprotectin obtained by the ELISA method from Bühlmann used in the routine work. Results The results showed poor correlation between the rapid test and the ELISA method. Furthermore, the comparison between the two ELISA-methods showed a poor correlation. Conclusion Evaluation of the two new methods showed poor correlation with the existing ELISA method from Bühlmann. Evaluation of the rapid test did not show any correlation with the two ELISA methods and the data cannot be trusted. It is difficult to conclude which of the two ELISA methods gives accurate results due to the absence of an international standard.

Background Calprotectin is a protein found in the cytoplasm of neutrophile granulocytes. In the course of inflammatory bowel disease (IBD), calprotectin is released during chronic inflammation in the gut. Activation of neutrophils during the inflammation is followed by activation and secretion of pro-inflammatory molecules such as calprotectin. Calprotectin is stable in stool up to 7 days and can therefore be used as a non-invasive marker for diagnosis, treatment and measurement of the disease activity in patients with IBD. The most common method for analysis of calprotectin concentration is ELISA. This method is time-consuming and many manufactures have therefore developed rapid tests as a faster alternative for quantification of calprotectin in stool. Aim The aim of the study was to evaluate one ELISA and one rapid test from the same manufacture compare the data with the existing ELISA-method used in the laboratory for routine analysis. Methods A rapid test (CalFast) and an ELISA method (CalPrest) from Eurospital, were used for analysis of calprotectin in stool. These two methods were compared with known concentrations of calprotectin obtained by the ELISA method from Bühlmann used in the routine work. Results The results showed poor correlation between the rapid test and the ELISA method. Furthermore, the comparison between the two ELISA-methods showed a poor correlation. Conclusion Evaluation of the two new methods showed poor correlation with the existing ELISA method from Bühlmann. Evaluation of the rapid test did not show any correlation with the two ELISA methods and the data cannot be trusted. It is difficult to conclude which of the two ELISA methods gives accurate results due to the absence of an international standard.

Objective: For the early detection of udder health disorders in praxi, it is necessary to use a method with high sensitivity. The aim of the pre - sent study was to investigate the sensitivity of a commercial Califor - nia Mastitis Test and a new reagent which was optimised for the de - tection of udder health disorders with somatic cell counts > 100,000 cells/ml. Material and methods: The viscosity of mixtures of test milks with standardised somatic cell counts (50,000-800,000 cells/ml) and test reagents were analysed in vitro. A total of 50 quarter fore - milk samples from cows without signs of clinical mastitis were in - vestigated using both California Mastitis Test reagents. Sensitivity and specificity were calculated. Results: The viscosity of mixtures increased with a higher somatic cell count. At a somatic cell count of 50,000 cells/ml, the mean viscosities were 3.20 mPa*s (commer - cial product) and 2.69 mPa*s (optimised reagent). At a somatic cell count of 100,000 cells/ml the viscosities increased to 3.43 mPa*s and 4.58 mPa*s, respectively. At a somatic cell count threshold of 100,000 cells/ml, marking the transition of the physiological status into a secretion disorder, the sensitivity of the commercial test was 76.7% and that of the optimised test was 97.7%. Conclusion and clinical relevance: The optimised California Mastitis Test allows - compared to the commercial product - the early detection of quarters or animals with high somatic cell counts. The results of the study indicate that the test result has to be evaluated immediately after the California Mastitis Test reaction.

Objective: For the early detection of udder health disorders in praxi, it is necessary to use a method with high sensitivity. The aim of the pre - sent study was to investigate the sensitivity of a commercial Califor - nia Mastitis Test and a new reagent which was optimised for the de - tection of udder health disorders with somatic cell counts > 100,000 cells/ml. Material and methods: The viscosity of mixtures of test milks with standardised somatic cell counts (50,000-800,000 cells/ml) and test reagents were analysed in vitro. A total of 50 quarter fore - milk samples from cows without signs of clinical mastitis were in - vestigated using both California Mastitis Test reagents. Sensitivity and specificity were calculated. Results: The viscosity of mixtures increased with a higher somatic cell count. At a somatic cell count of 50,000 cells/ml, the mean viscosities were 3.20 mPa*s (commer - cial product) and 2.69 mPa*s (optimised reagent). At a somatic cell count of 100,000 cells/ml the viscosities increased to 3.43 mPa*s and 4.58 mPa*s, respectively. At a somatic cell count threshold of 100,000 cells/ml, marking the transition of the physiological status into a secretion disorder, the sensitivity of the commercial test was 76.7% and that of the optimised test was 97.7%. Conclusion and clinical relevance: The optimised California Mastitis Test allows - compared to the commercial product - the early detection of quarters or animals with high somatic cell counts. The results of the study indicate that the test result has to be evaluated immediately after the California Mastitis Test reaction.

Background Calprotectin is a protein expressed in the cytoplasm inside the neutrophile granulocytes. During inflammatory bowel disease (IBD), the neutrophile granulocytes are involved in a complex interaction at the inflammatory area where they die and release their content into the intestinal lumen. Therefore, calprotectin in stool is a suitable marker for diagnosis and measurement of the disease-activity in patients with IBD. The most commonly used method to detect calprotectin in stool is ELISA, but the process of manual preparation of stool samples is time-consuming. Aim The objective of the study was to evaluate an extraction method that could replace manual preparation of fecal samples and to compare different methods for measuring Calprotectin in stool using two ELISA-methods from two manufacturers and one rapidtest. Methods For extraction of calprotectin from stool samples we used sample collector tubes from Epitope Diagnostics and fecal preparation kits from Roche. Two different ELISA-kits for measuring calprotectin concentration in stool were compared. Measurements of calprotectin with rapid-test from Epitope Diagnostics were also performed and were compared with the two ELISA kits. Results The results indicate a poor correlation between two extraction methods with Sample Collector Tube and Roche preparation kit. The comparison between the two ELISA-kits showed poor correlation. Evaluation of rapid test showed 33% false negative results with a cut-off value at 50 mg/kg. Conclusion Evaluation of products from Epitope Diagnostics showed poor correlation with the Bühlmann ELISA and an unreliable rapid test. Therefore, none of evaluated products from Epitope Diagnostics is accurate enough to be used for clinical diagnosis in the laboratory.

Background Calprotectin is a protein expressed in the cytoplasm inside the neutrophile granulocytes. During inflammatory bowel disease (IBD), the neutrophile granulocytes are involved in a complex interaction at the inflammatory area where they die and release their content into the intestinal lumen. Therefore, calprotectin in stool is a suitable marker for diagnosis and measurement of the disease-activity in patients with IBD. The most commonly used method to detect calprotectin in stool is ELISA, but the process of manual preparation of stool samples is time-consuming. Aim The objective of the study was to evaluate an extraction method that could replace manual preparation of fecal samples and to compare different methods for measuring Calprotectin in stool using two ELISA-methods from two manufacturers and one rapidtest. Methods For extraction of calprotectin from stool samples we used sample collector tubes from Epitope Diagnostics and fecal preparation kits from Roche. Two different ELISA-kits for measuring calprotectin concentration in stool were compared. Measurements of calprotectin with rapid-test from Epitope Diagnostics were also performed and were compared with the two ELISA kits. Results The results indicate a poor correlation between two extraction methods with Sample Collector Tube and Roche preparation kit. The comparison between the two ELISA-kits showed poor correlation. Evaluation of rapid test showed 33% false negative results with a cut-off value at 50 mg/kg. Conclusion Evaluation of products from Epitope Diagnostics showed poor correlation with the Bühlmann ELISA and an unreliable rapid test. Therefore, none of evaluated products from Epitope Diagnostics is accurate enough to be used for clinical diagnosis in the laboratory.

Methicillin-resistant Staphylococcus aureus (MRSA) isolates is a serious public health problem whose ever-increasing rate is commensurate with the pressure it is exerting on the healthcare system. At present, more than 20% of clinical S. aureus isolates in German hospitals are methicillin resistant. Strategies from low-prevalence countries show that this development is not necessarily inevitable. In the Scandinavian countries and the Netherlands, thanks to a rigorous prevention programme, MRSA prevalence has been kept at an acceptably low level (<1-3%). Central to these 'search and destroy' control strategies is an admission screening using several MRSA swabs taken from mucocutaneous colonisation sites of high-risk patients ('MRSA surveillance'). It has also been reported that the speed with which MRSA carriage is detected has an important role to play, as it is a key component of any effective strategy to prevent the pathogen from spreading. Since MRSA culturing involves a 2-3 day delay before the final results are available, rapid detection techniques (commonly referred to as 'MRSA rapid tests') using PCR methods and, most recently, rapid culturing methods have been developed. The implementation of rapid tests reduces the time of detection of MRSA carriers from 48-72 to 2-5 h. Clinical evaluation data have shown that MRSA can thus be detected with very high sensitivity. Specificity however is sometimes impaired due to false-positive PCR signals occurring in mixed flora specimens. In order to rule out any false-positive PCR results, a culture screen must always be carried out simultaneously. The data provide preliminary evidence that a PCR assay can reduce nosocomial MRSA transmission in high-risk patients or high-risk areas, whereas an approach that screens all patients admitted to the hospital is probably not effective. Information concerning the cost-effectiveness of rapid MRSA tests is still sparse and thus the issue remains debated., Die wachsende Bedrohung durch Methicillin-resistente S. aureus (MRSA) -Stämme spiegelt sich insbesondere in dem kontinuierlich steigenden Anteil der Methcillin-Resistenz bei den klinischen S. aureus -Isolaten wieder. Dieser liegt derzeit in Deutschland bei ca. 20%. Strategien aus Niedrigprävalenzländern zeigen, dass eine solche Entwicklung nicht zwangsläufig ist. In Skandinavien und den Niederlanden hat sich die MRSA-Rate durch ein rigoroses Eradikations- und Präventionsprogramm auf einem konstant sehr niedrigen Niveau (<1-3%) stabilisiert. Im Zentrum einer solchen 'search and destroy' Strategie steht die frühestmögliche Identifikation von MRSA-Trägern durch systematische Screening-Abstriche bei Krankenhaus-Aufnahme. Da mit den kulturellen Techniken 2-3 Tage bis zum Vorliegen des definitiven Befundes vergehen, wurden schnellere Nachweisverfahren auf Basis der Polymerase-Kettenreaktion oder einer Schnellkultivierung (sogenannte MRSA-Schnellteste) entwickelt. Mit den innovativen Testkonzepten und -formaten ist es inzwischen möglich, eine MRSA-Trägerschaft zuverlässig innerhalb weniger Stunden auszuschließen. Positiv-Nachweise sind allerdings mit der Möglichkeit falsch positiver Ergebnisse behaftet und bedürfen weiterhin der kulturellen Bestätigung. Die bisherigen (begrenzten) Erfahrungen lassen vermuten, dass ein Schnelltest in den Hochrisiko-Kollektiven die Rate der nosokomialen MRSA-Übertragungen senken kann. Die Daten zur Kosteneffizienz sind für eine definitive Beurteilung noch nicht aussagekräftig genug und zudem teilweise widersprüchlich.

L’objectif de cet article est de faire le point sur le processus de création et de validation d’un test rapide pour quatre formes de base du syndrome CAN (Child Abuse and Neglect, Négligences et abus sur enfants). La base théorique pour la création du test consiste en une approche intégrée mettant l’accent sur l’approche socio-interactive (Bentowim, 1998 ; Gjuričová, 2000 ; Vlčková, 2001 ; Šramová, 2004 ; Fuchsová, 2009 ; et al.). Les principales méthodes appliquées lors de la création du test comprenaient l’analyse de contenu de textes spécialisés, la méthode Delphi et la technique du groupe nominal. Les résultats obtenus ont été traités après une application répétée du test dans la pratique. Les résultats des tests ont montré que les groupes de jeunes enfants sont les plus problématiques en termes de diagnostic, que de nombreux enfants testés se trouvent dans le spectre à haut risque, et que les estimations des chercheurs sont beaucoup plus optimistes que la réalité., The aim of this article is to report on the process of creation and validation of a rapid test for four basic forms of the CAN (Child Abuse and Neglect) syndrome. The theoretical base for the creation of the test consists of an integrated approach with the emphasis on the socio-interactive approach (Bentowim, 1998; Gjuričová, 2000; Vlčková, 2001; Šramová, 2004; Fuchsová et al., 2009). The main methods applied during the test creation included content analysis of specialised texts, the Delphi method and the nominal group technique. The obtained results were processed after a repeated implication of testing in practice. The results of the testing showed that groups of young children are the most problematic in terms of diagnostics, that many of the tested children are in the high-risk spectrum and that the estimates of research workers are much kinder than the reality.