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Objective: Trichinellosis is a globally distributed food-borne parasitic disease. Initially, diagnosis is usually made based on clinical signs, symptoms, and history of eating raw or undercooked meat. In the present study, an immunochromatographic test (ICT) kit was developed to diagnose trichinellosis by detecting IgG antibodies in sera of infected humans. Methods: Somatic extract from Trichinella spiralis larvae was used as the antigen for the ICT kit development. Diagnostic efficacy was evaluated using human serum samples from proven trichinellosis patients, healthy persons, and those with other parasitic infections. Results: The diagnostic sensitivity, specificity, positive and negative predictive values and accuracy of the ICT kit were 100.0% (95%; CI 88.8 to 100.0%), 92.5% (95% CI; 86.9 to 96.2%), 73.8% (95% CI; 58.0 to 86.1%), 100.0% (95% CI; 97.3 to 100.0%) and 93.8% (95% CI; 89.2 to 96.9%), respectively. Conclusions: This ICT diagnostic kit can be used as a testing tool for human trichinellosis. This test should permit rapid detection of infection to enable prompt anthelminthic treatment. It can also be used for retrospective diagnoses and field surveys based at laboratories where sophisticated equipment is lacking.

A more rapid and less complicated test is required in clinical settings to diagnose pertussis. We need to detect Bordetella pertussis, which mainly causes pertussis, as early as possible, because pertussis is more likely to become severe in infants, and people around them can easily become the source of infection due to its strong infectivity. Nevertheless, methods that can detect B. pertussis rapidly and efficiently are lacking. Therefore, we developed a new immunochromatographic antigen kit (ICkit) for the early diagnosis of pertussis. The ICkit detects B. pertussis antigens in a nasopharyngeal swab without equipment and provides the result in about 15 min with a simple procedure. Additionally, a prospective study to evaluate the ICkit was conducted in 11 medical institutions, involving 195 cases with suspected pertussis. The sensitivity and specificity of the ICkit were 86.4% (19/22) and 97.1% (168/173), respectively, compared with the real-time polymerase chain reaction (rPCR). The ICkit detected the antigen in both children and adults. Furthermore, the ICkit detected the antigen until the 25th day from the onset of cough, when rPCR detected the antigen. Thus, the ICkit demonstrated a high correlation with rPCR and would help diagnose pertussis more rapidly and efficiently.

Clostridioides difficile infection is a public health problem because of it is easily spread; with harmful consequences, it is essential to reduce hospital costs and prevent its dissemination by having a precise diagnosis. The gold standard for its diagnosis is polymerase chain reaction (PCR); however, the technique is not available for all laboratories due to the high cost. New approaches using non-molecular tests to detect C. difficile and toxin A/B production has been proposed to improve cost benefits. The objective of this study is to compare molecular methods (PCR) and rapid methods (immunochromatographic test and enzymatic immunoassay). A series of tests comprising these diagnostic techniques was performed with 50 patients with a clinical diagnosis for Clostridioides difficile on GeneXpert® devices test; a calculation of the sensitivity was executed, followed by a comparison of the efficiency of all techniques. Greater sensitivity was observed in the PCR-based methods (BD MAX™ and BioFire FilmArray®) and the GDH-based assays (RIDASCREEN® and Alere Techlab®). The proposed algorithm represents minor monetary disadvantages but a significant temporal optimization of 10%. Future studies concerning both positive and negative results could be advantageous because of the possibility of calculating more method concordance indexes, such as the specificity and Kappa index, in addition to being able to indicate a monetary profit if the proposed algorithm was applied due to the nonproceeding PCR cases.

Introduction Dengue fever, caused by any of the four dengue viruses (DENV1–4), is endemic in more than 100 countries around the world. Each year, up to 400 million people get infected with dengue virus. It is one of the most important arthropod-borne viral diseases. Dengue’s global presence poses a medical threat to deploying military personnel and their dependents. An accurate diagnosis followed by attentive supportive care can improve outcomes in patients with severe dengue disease. Dengue diagnostic tests based on PCR and ELISA platforms have been developed and cleared by the U.S. FDA. However, these diagnostic assays are laborious and usually require highly trained personnel and specialized equipment, which presents a significant challenge when conducting operations in austere and resource-constrained areas. InBios International, Inc. (Seattle, WA) has developed two rapid and instrument-free immunochromatographic test prototype devices (multiplex and traditional formats) for dengue diagnosis. Materials and Methods To determine the performance of the InBios immunochromatographic tests, 183 clinical samples were tested on both prototype devices. Both assays were performed without any instruments and the results were read in 20 minutes. Results The traditional format had better overall performance (sensitivity: 97.4%; specificity: 90%) than the multiplex format (sensitivity: 86.9%; specificity: 63.3%). The traditional format was superior in serotype-specific detection with 100% overall sensitivity for DENV1, DENV3, and DENV4 and 93.3% sensitivity for DENV2 compared to the multiplex format (91.7%, 78.3%, 83.3%, and 96.3% for DENV1, 2, 3, and 4, respectively). The traditional format was easier to read than the multiplex format. The multiplex format was simpler and faster to set up than the traditional format. Conclusions The InBios traditional format had a better overall performance and readability profile than the multiplex format, while the multiplex format was easier to set up. Both formats were highly sensitive and specific, were easy to perform, and did not require sophisticated equipment. They are ideal for use in resource-limited settings where dengue is endemic. Based on our overall assessment, the traditional format should be considered for further development and used in the upcoming multicenter clinical trial toward FDA clearance.

Fascioliasis, a food- and water-borne trematodiasis, has been identified as a public health threat by the World Health Organization, with millions of people estimated to be infected or at risk of infection worldwide. We developed an immunochromatographic test (ICT) as a point-of-care (POC) tool for the rapid serodiagnosis of human fascioliasis caused by Fasciola gigantica and evaluated their diagnostic ability. Two tests were developed using antigens from adult F. gigantica excretory-secretory (ES) product and recombinant F. gigantica cathepsin L (rFgCL). Sera from 12 patients with parasitologically proven fascioliasis caused by F. gigantica, 18 with clinically suspected fascioliasis, 65 with other parasitic infections, and 30 healthy controls were used. Using a cutoff of > 0.5 for antibody detection, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the ES-based ICT method were 100%, 98.9% 96.8%, 100%, and 99.2%, respectively, and those of the rFgCL-based ICT method were 86.7%, 93.7%, 81.3%, 95.7%, and 92.0%, respectively. The concordance between the two methods was 91.2%. Tests using F. gigantica ES and rFgCL antigens can be employed quickly and easily as POC diagnostic tools. They can be used to support the clinical diagnosis of human fascioliasis gigantica and in large-scale surveys in endemic areas throughout tropical regions without necessitating additional facilities or ancillary supplies.

Immunochromatographic test systems known to foreign laboratory diagnostic experts as lateral flow immunoassay (LFIA) are simplified tape formats of modern biosensors. For 60 years, they have been widely used for the rapid detection of target molecules (ligands) in biosubstrates and the diagnosis of many diseases and conditions. The growing popularity of these test systems for providing medical care or diagnostics in developing countries, medical facilities, in emergency situations, as well as for individual home use by patients while monitoring their health are the main factors contributing to the continuous development and improvement of these methods, the emergence of a new generation of formats. The attractiveness and popularity of these fast, easy-to-use, inexpensive and portable diagnostic tools is associated primarily with their high analytical sensitivity and specificity, as well as the ease of interpretation of the results. These qualities have passed the test of time, and today LFIA test systems are fully consistent with the modern world concept of «point-of-care testing», finding wide application not only in medicine, but also in ecology, veterinary medicine, and agriculture. This review will highlight the modern principles of designing the most widely used formats of immunochromatographic test systems for clinical laboratory diagnostics, summarize the main advantages and disadvantages of the method, as well as current achievements and prospects of LFIA technology. Modern innovations aimed at improving the analytical characteristics of LFIA technology are interesting, promising and can bring additional benefits to immunochromatographic platforms that have gained popularity and attractiveness for six decades.

The evaluating results of the diagnostic characteristics of an immunochromatographic test for the detection of fecal occult blood (hemoglobin) were presents in the article. The test was approved samples without hemoglobin and model samples containing of standardized preparation of hemoglobin in various concentrations in comparison with two immunochromatographic test systems. The developed test system identified hemoglobin in concentrations higher 50 ng/ml in 99,2% cases, the specificity of the analysis was 98,1%. The obtained levels of sensitivity and specificity were higher the similar parameters for the compared test systems. The immunochromatographic FOB-test can be used for rapid analysis in the primary screening of colorectal cancer.

Detection of Legionella pneumophila serogroup 1 urinary antigens is the most widely used technique for the diagnosis of Legionnaires' disease (LD). The aim of this study was to evaluate the performance of the Legionella K-set® immunochromatographic test, in comparison with the BinaxNOW® Legionella urinary antigen card (UAC) on concentrated urine samples (US). A total of 250 concentrated US including 200 prospective US sent to the laboratory for urinary antigens' testing and 50 frozen US from patients with confirmed LD were tested. Positive US were retested after boiling (5 min, 100 °C). Each US leading to discordant results between the two tests was further tested using Binax™ Legionella EIA. Then, 10 additional positive non-concentrated US were tested using both tests. On concentrated US, Legionella K-set® test showed concordant results with that of BinaxNOW® Legionella. All negative US with BinaxNOW® were negative with Legionella K-set® test. For the 50 frozen US, all were positive with BinaxNOW® and 49 were positive with Legionella K-set®, all confirmed after boiling except 3 US which led to uninterpretable results with Legionella K-set®, due to a migration defect. Three of the 10 additional positive non-concentrated US were found negative with Legionella K-set® and only 1 US remained negative after concentration. All these positive non-concentrated US were positive with BinaxNOW® Legionella. The performance of the Legionella K-set® test is comparable to that of BinaxNOW® Legionella UAC, if performed on concentrated US.

Background This retrospective case-control study aimed to investigate the factors associated with the occurrence of human visceral leishmaniasis (VL) in the municipality of Rondonópolis, which is a highly endemic area for VL in Central-Western Brazil. Methods All VL cases reported in Rondonópolis from 2011 to 2016 were included. For each case, two neighborhood- and age-matched controls with the absence of past and present history of VL and negative rk39-based immunochromatographic test, were recruited. Data were retrospectively collected through interviews that assessed socioeconomic aspects, housing features, backyard characteristics, presence of animals and daily habits. A multivariate conditional logistic regression analysis was used to identify factors associated with human VL. Results During the study period, 81 VL cases were reported in Rondonópolis, of which 37 (45.7%) were included in this study. Seventy controls were also included. The variables associated with VL occurrence were the outdoor location of a bathroom and/or kitchen separated from the rest of the house (OR 7.8; 95% CI 2.1 to 29.5), the presence of a vegetable garden (OR 5.3; 95% CI 1.3 to 21.2) and the presence of decaying fruits (OR 10.7; 95% CI 2.0 to 52.1) in the backyard. Conclusions Our findings suggest an association between backyard characteristics and VL. This may be useful in guiding preventive and control measures against zoonotic VL worldwide.

Human strongyloidiasis is an important gastrointestinal disease with an estimated 30 to 100 million people infected. Prevalence is generally underestimated since many infections are asymptomatic, and traditional diagnostic tests based on parasitological examination of stool samples are not adequately sensitive. Serological tests are useful and supportive but are still only available in a reference research setting. We made an immunochromatographic test (ICT) kit for rapid serodiagnosis of human strongyloidiasis. The antigen used in the ICT kit was extracted from larvae of Strongyloides stercoralis. Diagnostic efficacy of the kit was evaluated using human serum samples from strongyloidiasis patients, healthy persons, and those with other parasitoses. When using a cutoff level of 0.5 or above, the diagnostic sensitivity, specificity, and positive and negative predictive values at the prevalence of infection of 34.4%, were 93.3%, 83.7%, 76.7%, and 95.6%, respectively. This ICT kit is easy to use at the point-of-care and a result can be obtained in 15 min. Sophisticated instruments and highly trained staff are not required. It can be used in several diagnostic and public-health settings, e.g., prevalence surveys in endemic areas, confirmation and monitoring of cure post-treatment, diagnosis and screening of infected but asymptomatic individuals, and populations “at risk” for hyperinfection syndrome or disseminated strongyloidiasis if they are given immunosuppressive treatment for other conditions.

Background The H9N2 subtype of avian influenza virus (AIV) has become the most widespread subtype of AIV among birds in Asia, which threatens the poultry industry and human health. Therefore, it is important to establish methods for the rapid diagnosis and continuous surveillance of H9N2 subtype AIV. Methods In this study, an antigen-capture enzyme-linked immunosorbent assay (AC-ELISA) and a colloidal gold immunochromatographic test (ICT) strip using monoclonal antibodies (MAbs) 3G4 and 2G7 were established to detect H9N2 subtype AIV. Results The AC-ELISA method and ICT strip can detect H9N2 subtype AIV quickly, and do not cross-react with other subtype AIVs or other viruses. The detection limit of AC-ELISA was a hemagglutinin (HA) titer of 4 for H9N2 subtype AIV per 100 μl sample, and the limit of detection of the HA protein of AIV H9N2 was 31.5 ng/ml. The ICT strip detection limit was an HA titer of 4 for H9N2 subtype AIV per 100 μl sample. Moreover, both detection methods exhibited good reproducibility and repeatability, with coefficients of variation Conclusions The developed AC-ELISA and ICT strips displayed high specificity, sensitivity, and stability, making them suitable for rapid diagnosis and field investigation of H9N2 subtype AIV.

The developing and evaluating results of the diagnostic characteristics of an immunochromatographic test for the detection of fecal occult blood (hemoglobin) were presents in the article. The test was approved samples without hemoglobin and model samples containing of standardized preparation of hemoglobin in various concentrations. The developed test system identified hemoglobin in concentrations higher 5 μg/g feces in 97.6% cases, the specificity of the analysis was 100%. The immunochromatographic FOB-test can be used for rapid analysis in the primary screening of colorectal cancer.

The factors associated with Leishmania spp. infection in dogs are still poorly understood. This study aimed to identify such factors among domestic dogs from the Brazilian municipality of Rondonopolis, which recently emerged as an endemic area with intense transmission of human visceral leishmaniasis (VL). It was a household-based cross-sectional study conducted between 2016 and 2017. Interviews were conducted with 405 dog owners considering their socioeconomic characteristics, and environmental aspects of the household and its adjacent areas. In addition, 600 dogs were evaluated regarding physical characteristics, behavior, and care provided by the owner. Seropositive animals were those that showed reactivity in a rapid immunochromatographic test and enzyme-linked immunosorbent assay, which are currently recommended for canine visceral leishmaniasis (CVL) diagnosis in Brazil. A multivariable logistic regression analysis was employed to determine the associated factors. Low social class [OR = 2.0; 95% CI = (1.2–3.2)], presence of acerola tree ( Malpighia emarginata ) in the yard [OR = 2.2; 95% CI = (1.2–4.1)], presence of more than one dog in the household [OR = 2.0; 95% CI = (1.3–3.3)], horse and/or cattle breeding [OR = 12.0; 95% CI = (1.9–73.6)], existence of houses with yard adjacent to the home [OR = 4.0; 95% CI = (1.3–12.2)], presence of apparent signs consistent with CVL [OR = 10.6; 95% CI = (5.8–19.4)], dog staying mostly in the yard during the day [(OR = 4.8; 95% CI = (1.1–21.4)], and lack of cleaning of the dog's shelter [(OR = 1.9; 95% CI = (1.1–3.2)] were identified as the factors associated with Leishmania spp. infection. These results support the importance of socioeconomic and environmental aspects in the occurrence of Leishmania spp. infection. In addition, they may be useful in guiding control strategies in areas where zoonotic VL is endemic.

Background: Leishmaniasis caused by different species of Leishmania affect 98 countries worldwide. Visceral Leishmaniasis (VL) is the mortal clinical presentation of the disease that causes the dead to more than 90% of the patients who suffer it. The diagnosis of VL is made by the direct observation of the parasite in bone marrow, spleen and/or liver aspirates that requires complex proceedings. Therefore, serum samples are submitted to Indirect Immunofluorescence to identify the presence of anti-Leishmania antibodies. Despite the variability in the diagnostic performance of the Immunochromatographic Tests (ICTs), there are many evidences that suggest that ICTs can be used for epidemiological screening. However, in Colombia there are not any evidence about the performance of the ICTs for VL diagnosis, both for human and canine serum samples. Therefore, this study evaluated the diagnostic performance of 4 ICTs for VL (2 ICTs in human sera and 2 ICTs in canine sera) in samples from endemic areas of Colombia. Methods: We selected a total of 156 human serum samples (82 positive and 74 negative for VL) and 126 canine serum samples (71 positive and 54 negative) diagnosed by in house Indirect Immunofluorescence (IIF). The samples were submitted to the ICTs following the manufacturers' instructions. Statistical analysis was performed to evaluate the diagnostic performance of each ICT in comparison with the IIF. PCR for HSP70 gene and sanger sequencing was performed in samples with negative results for both ICTs. Results: The sensitivity (S) of both ICTs for human samples (Ad-bio Leishmania IgG/IgM Combo Rapid Test and Kalazar Detect™) was 91.5% and specificity (E) were 93.2 and 89.2% respectively, while for the ICTs tested on canine samples (Kalazar Detect™ Rapid Test, Canine and DPP® CVL rapid test) we found S values between 82.9 and 85.7% and E values between 79.6 and 92.6%. We found L. infantum by PCR and sequencing in 2 human samples, and L. braziliensis and L. amazonensis in canine serum samples that were negative by both ICTs. Conclusions: We conclude that both tests evaluated on human samples have a similar diagnostic performance, while the Kalazar Detect™ Rapid Test, Canine showed a better diagnostic performance than the DPP® CVL rapid test evaluated on canine samples. Also, we suggest that it is necessary to design tests with antigens of the circulating strains to increase its diagnostic utility. © 2019 The Author(s).

The rapid detection of carbapenemase-producing Gram-negative bacteria is indispensable to optimize treatment and avoid the further spread of these organisms. While phenotypic tests are time-consuming and PCR is expensive and not available in many routine laboratories, immunochromatographic tests (ICT) can provide rapid results at moderate cost. The aim of this study was to determine the performance of the new ICT RESIST-4 O.K.N.V. K-SeT (Coris BioConcept, Gembloux, Belgium) which can detect the four most prevalent carbapenemases: OXA-48-like, KPC, NDM, and VIM. Additionally, we analyzed the impact of different culture conditions on the sensitivity. The new ICT was challenged with 169 carbapenem-resistant isolates. Of these, 125 were carbapenemase producers: 43 OXA-48-like, 15 KPC, 29 NDM, and 43 VIM. The ICT correctly detected 129 of the 130 carbapenemases resulting in a sensitivity of 99.2% and specificity of 100% when tested from Mueller-Hinton agar (MHA). The sensitivity of the assay increased to 100% when performed from zinc-supplemented MHA and sheep blood agar (SBA) or when the inoculum was harvested from the inhibition zone of an ertapenem disk. All carbapenemase-negative carbapenem-resistant bacteria tested negative and no cross-reaction was observed. The new ICT is an excellent test for rapid diagnostic of carbapenemase-producing Gram-negatives in the routine laboratory. It is easy to handle and provides rapid results with a high sensitivity. For best results, we recommend to obtain the inoculum from a medium with sufficient zinc or from the inhibition zone of an ertapenem disk.

Emotional stress negatively affects the quality of a person’s daily life. From a physiological point of view, stress is expressed in the excitation of the hypothalamic–pituitary–adrenal cortex axis, which leads to the release of the hormone cortisol into the blood. We developed a lateral flow immunoassay to detect cortisol in human salivary fluid and tested it on 10 healthy volunteers daily for about one month n = 293 saliva samples). Cortisol was detected in concentrations ranging from 1 to 70 ng/mL. Salivary cortisol levels were confirmed by ELISA. The straightness range of LFIA calibration was from 1 to 100 ng/mL. The diagnostic sensitivity of the method was 73%. It was found that in 3 out of 10 subjects, fluctuations in the level of cortisol in saliva partially corresponded to the subjectively assessed level of stress.

In the last 40 years, Latin America countries, including Brazil, have suffered from the emergence and reemergence of arboviruses, first Dengue (DENV) and recently Zika (ZIKV) and Chikungunya (CHIKV). All three arboviruses are currently endemic in Brazil and have caused major outbreaks in recent years. Rio de Janeiro city, host of the last Summer Olympic Games and the Football World Cup, has been specially affected by them. A surveillance system based on symptomatic reports is in place in Rio, but the true number of affected individuals is unknown due to the great number of Zika, Dengue and Chikungunya asymptomatic cases. Seroprevalence studies are more suitable to evaluate the real number of cases in a given population. We performed a populational seroprevalence survey in Rio, with recruitment of a sample of volunteers of all ages and gender from July to October 2018, within randomly selected census tracts and household. A total of 2,120 volunteers were interviewed and tested with rapid immunochromatographic test for ZIKV, DENV and CHIKV. Individuals with positive results for IgG and/or IgM from only one virus were classified accordingly, while those with test results positive for both ZIKV and DENV were classified as flaviviruses. We corrected for sample design and non-response in data analysis, and calculated point estimate prevalence and 95% confidence intervals for each virus. Arbovirus prevalence in the Rio's population (n = 6,688,927) was estimated at 48.6% [95% CI 44.8–52.4] (n = 3,254,121) for flaviviruses and at 18.0% [95% CI 14.8–21.2] (n = 1,204,765) for CHIKV. Approximately 17.0% [95% CI 14.1–20.1] (n = 1,145,674) of Rio´s population had no contact with any of the three arboviruses. The reported cases of Zika, Dengue and Chikungunya by the current surveillance system in place is insufficient to estimate their real numbers, and our data indicate that Zika seroprevalence could be at least five times and Chikungunya 45 times bigger. The high number of individuals having never been infected by any of the three arboviruses, may indicate a proper scenario for future outbreaks.

Oropharyngeal candidiasis is the most common opportunistic fungal infectious disease. Culture methods and microscopy are used to detect the presence of Candida species in clinical specimens. We have previously developed an immunochromatographic test (ICT) to enable the simple and rapid diagnosis of candidiasis. In this study, we evaluated the performance of the ICT for the detection of Candida species from pharyngeal swabs and compared the results with those of the culture method. The isolated Candida species were identified using polymerase chain reaction-restriction fragment length polymorphism, and viable cell counts were determined using selective chromogenic agar. The detection rate of C. albicans was 63.3% and 0% among ≤102 and ≥ 106 colony-forming units (CFU)/mL of viable Candida cells from pharyngeal swabs, respectively. The detection rate of non C. albicans Candida species, especially C. glabrata, increased commensurately from 16.7% at ≤102 CFU/mL to 75.0% at ≥106 CFU/mL. Among the 300 pharyngeal swabs analyzed, 59 cultures detected Candida species at a count of >103 CFU/mL (53 were ICT-positive). Of the remaining 241 culture-negative specimens, 219 were ICT-negative. The sensitivity, specificity, and accuracy of the ICT were 89.8%, 90.9%, and 90.7%, respectively. Taken together, the ICT evaluated can be made readily available for clinical use in detecting Candida.

The main goal of this work is to develop an economical, portable, disposable, and reliable point of care paper biosensor based on visualization, which can be used to detect viruses, bacteria, and proteins. However, the sensitivity of immunochromatography test (ICT) strips based on nitrocellulose to target detection has always been a problem. Here, we use an electrospun nitrocellulose (ENC) fiber membrane instead of traditional nitrocellulose fiber membrane to construct ICT strips for early pregnancy detection. By proper selection of the diameter of the ENC fiber to adjust the pore size, porosity, and morphology of the membrane, ICT strips with low flow rate and high protein loading were obtained. Based on these properties, a convenient and sensitive method for the colorimetric determination of human chorionic gonadotropin was developed. Under the optimal conditions, the detection limit of ICT based on ENC membrane is 10 mIU mL−1 (S/N = 3), the linear detection range is 5–1000 mIU mL−1, and the linear relationship is Y = 0.0434 X − 0.0136 (R2 = 0.9802). In addition, the test strip has good specificity and stability, and will not produce false-positive results.

Introduction: Intestinal parasites are known to cause infection in humans worldwide, with higher prevalence in low- and middle- incoming countries. Children are greatly affected leading to malnutrition and subsequently to physical and cognitive development impairment. Despite the scale and importance of this issue, there are few studies conducted in Mozambique concerning parasitic intestinal infections in hospitalized children. To our knowledge this is the first published report with data on this subject from Northern Mozambique. Methodology: A cross-sectional study was conducted in 2012 and 2013 in 831 children, attending the Central Hospital of Nampula in Northern Mozambique. One single stool sample was obtained from each child. Socio-demographic and clinical data were also obtained. Parasitological analysis of feces was performed through direct examination and Ritchie concentration technique and Giardia duodenalis antigen detection by rapid immunochromatographic test. Modified Ziehl-Neelsen staining was used for coccidia detection. Results: The global prevalence of pathogenic intestinal parasites was 31.6%. G. duodenalis (23.9%) was by far the most prevalent parasite followed by Strongyloides stercoralis (4.1%) and Cryptosporidium sp. (3.4%). Intestinal parasites were more frequent in older children (p = 0.005; aOR = 1.025). Conclusions: This work is one of the few published studies reporting intestinal parasites infection in hospitalized children. The percentage of children affected with G. duodenalis is higher than found in other studies in the African region. This highlights the need of particular attention being given to this intestinal protozoan and its resistance to water treatment, as well as to environmental health and personal hygiene.

The ciprofloxacin (CIP) abuse has caused many problems threatening to human health. Here, we design the quantum dot microsphere (QDM) based immunochromatographic quantitative CIP test strip: when the sample under detection contains CIP, the QDM-monoclonal antibody (mAb) probes bound with the CIP and cannot be captured by CIP-bovine serum albumin (BSA) conjugation dispersed on the T lines, reducing the fluorescence intensities. These test strips can provide a low detection limit of 0.05 ng/mL and a wide linear detection range from 0.1 ng/mL to 100 ng/mL in high sensitivity and accuracy as well as good selectivity, reproducibility and stability. Moreover, a smartphone based test strip reader with the size of 85 mm × 48 mm × 44 mm is also fabricated using 3-D printing to automatically and quantitatively detect CIP. The whole process of CIP detection can be finished within 15 min, but only cost ~1 RMB (10 cents).

The presented study is focused on the impact of binding zone location on immunochromatographic test strips on the analytical parameters of multiplex lateral flow assays. Due to non-equilibrium conditions for such assays the duration of immune reactions influences significantly the analytical parameters, and the integration of several analytes into one multiplex strip may cause an essential decrease of sensitivity. To choose the best location for binding zones, we have tested reactants for immunochromatographic assays of lincomycin, chloramphenicol, and tetracycline. The influence of the distance to the binding zones on the intensity of coloration and limit of detection (LOD) was rather different. Basing on the data obtained, the best order of binding zones was chosen. In comparison with non-optimal location the LODs were 5&ndash, 10 fold improved. The final assay provides LODs 0.4, 0.4 and 1.0 ng/mL for lincomycin, chloramphenicol, and tetracycline, respectively. The proposed approach can be applied for multiplexed assays of other analytes.

Background Commonly, the application of radiological and clinical criteria and the determination of galactomannan (GM) in respiratory samples are used as a diagnostic tool for the detection of invasive pulmonary aspergillosis (IPA). Materials/methods In this study, two lateral flow assays, OLM Aspergillus lateral flow device (LFD) and IMMY sōna Aspergillus Galactomannan lateral flow assay (LFA), were evaluated at two tertiary hospitals in Germany. A total of 200 bronchoalveolar lavage (BAL) samples from patients with suspicion of IPA were analysed retrospectively. LFD and LFA were evaluated against four different criteria: Blot, EORTC/MSG, Schauwvlieghe and extended Blot criteria and additionally against GM. Results The evaluation of four algorithms for the diagnosis of IPA showed that there exist good diagnostic tools to rule out an IPA even before results of Aspergillus culture are available. Sensitivities and negative predictive values are generally higher for the LFA than for the LFD in all four criteria. Specificity and positive predictive values varied depending on the classification criteria. The total agreement between the GM and the LFA cube reader (cut-off = 1) was 84%. The correlation between the GM and LFA was calculated with r = 0.8. Conclusion The here presented data indicate that a negative LFA result in BAL fluid can reliable rule out an IPA in a heterogeneous group of ICU patients based on the original Blot criteria. LFA seems to be a promising immunochromatographic test exhibiting a good agreement with positive GM values.

Rapid diagnostic tests (RDTs) have been developed to detect influenza A virus for the swift diagnosis and management of patients. However, despite the simplicity and convenience, the low sensitivity of RDTs remains a limitation for their use in point of care testing (POCT). In this study, we developed a rapid fluorescent immunochromatographic strip test (FICT) and the performance of FICT was confirmed by the real-time reverse transcription-polymerase chain reaction (rRT-PCR) of H1N1, compared with that of RDT. The limit of detection (LOD) of FICT was improved by 16-fold compared to RDT. FICT showed 85.29% sensitivity (29/34) (95% Confidence Interval [95% CI]: 68.94 to 95.05), 100% specificity (26/26) (95% CI: 86.78 to 100.00), and a strong correlation (kappa; 0. 92) compared with rRT-PCR (20 ≤ Ct ≤ 36). In contrast, RDT (Standard Diagnostics [SD] BIOLINE Influenza Ag A/ B/ A(H1N1) Pandemic) showed 55.88% sensitivity (19/34) (95% CI: 37.87 to 72.82), 100% specificity (26/26) (95% CI: 77.07 to 100), and had a fair correlation with rRT-PCR (kappa; 0. 75). FICT had better sensitivity than RDT (P

Background: Differentiating scrub typhus from other acute febrile illness is difficult due to non specificity of clinical symptoms and relative absence of eschar in Indian population. The diagnosis thus relies mainly on laboratory tests. Antibody based serological tests are mainstay of scrub typhus diagnosis. Here, we evaluated the diagnostic performance of IgM ELISA, IgM IFA and ICT to detect antibodies against O. tsutsugamushi in acute serum of febrile patients. Methodology: The serum samples from 600 randomly selected patients suffering from acute undifferentiated fever were tested by all the three tests mentioned above. We used latent class analysis to generate unbiased results as all the tests for scrub typhus diagnosis are imperfect and none of them can be considered as reference standard. Results: We found that IgM ELISA with cutoff titer 0.5 OD has high diagnostic accuracy (sensitivity 99.9% and specificity 99.15) than IgM IFA (sensitivity 96.8% and specificity 99.7%) for scrub typhus diagnosis. ICT used in our study had very high specificity 100% but low sensitivity (38%) which would limit its use for acute serum samples. ICT being a screening or point of care test, has to be more sensitive while some compromise with specificity is affordable. Hence, optimal cutoff for ICT should be evaluated under different settings. Conclusion: IgM ELISA being simple and affordable could be an alternative diagnostic test to IgM IFA which is subjective and costly.

Over 90% of schistosomiasis infections occur in sub-Saharan Africa. A rapid ICT test would be a cheap and easy tool that could be used also in the field. We preliminarily evaluated the performance of a new Schistosoma black-latex based IgG-IgM ICT (Black-ICT) on serum samples. The results indicate a high sensitivity (98.0%) but the specificity depends on the application of a cut-off value that can discriminate between positive and negative samples. Considering a possible direct application of this test on blood from finger prick, the results are promising, providied that a signal intensity scale is developed, guiding the result interpretation.

Nigeria has the largest population at risk for lymphatic filariasis (LF) in Africa. This study used a transmission assessment survey (TAS) to determine whether mass drug administration (MDA) for LF could stop in 21 districts, divided into four evaluation units (EUs), of Plateau and Nasarawa States, Nigeria, after 8–12 years of annual albendazole–ivermectin treatment. A total of 7,131 first- and second-year primary school children (approximately 6–7 years old) were tested for LF antigen by immunochromatographic test (ICT) from May to June 2012. The target sample size of 1,692 was exceeded in each EU (range = 1,767–1,795). A total of 25 (0.4%) individuals were ICT positive, with the number of positives in each EU (range = 3–11) less than the TAS cutoff of 20, meaning that LF transmission had been reduced below sustainable levels. As a result, 3.5 million annual albendazole–ivermectin treatments were halted in 2013. Combined with the previous halt of MDA for LF in other parts of Plateau and Nasarawa, these are the first Nigerian states to stop LF MDA statewide. Posttreatment surveillance is ongoing to determine if LF transmission has been interrupted.

OBJECTIVES: There is an urgent need for accurate and fast diagnostic tests capable of identifying carbapenemase producers. Here, we assessed the performance of a new multiplex lateral flow assay (OKN K -SeT) for the rapid detection of OXA-48-like, KPC and NDM carbapenemase-producing Enterobacteriaceae from culture colonies. METHODS: Two hundred collection isolates with characterized β-lactamase content and 183 non-duplicate consecutive isolates referred to two National Reference Centres over a 2 month period in 2016 were used to evaluate the OKN K -SeT assay. RESULTS: The assay correctly detected all 42 OXA-48-like-, 27 KPC- and 30 NDM-producing isolates from the collection panel, including 7 isolates that co-produced NDM and OXA-181 carbapenemases. No cross-reactivity was observed with non-targeted carbapenemases ( n = 41) or with non-carbapenemase producers ( n = 60). Prospectively, all OXA-48-like ( n = 69), KPC ( n = 9) and NDM ( n = 19) carbapenemase-producing Enterobacteriaceae isolates were correctly detected, while 11 carbapenemase producers not targeted by the assay went undetected [VIM ( n = 8) and OXA-23/OXA-58-like ( n = 3)]. Overall, the sensitivity and specificity of the assay were 100%. CONCLUSIONS: The OKN assay is efficient, rapid and easy to implement in the workflow of a clinical microbiology laboratory for the confirmation of OXA-48, NDM and KPC carbapenemases. This test represents a powerful diagnostic tool as it enables the rapid detection of the most clinically important carbapenemases without the need for more costly and less frequently available molecular assays.

We standardized an immunochromatographic test (IC) for heat-labile toxin I (LT-I) detection using LT-I antibodies and a specific platform containing the apparatus for application, assembly and cutting. IC detected as little as 62.5ng/mL of purified LT-I toxin and presented 91% sensitivity, 99.5% specificity and 96.0% accuracy, thereby proving to be an excellent point-of-care test for the diagnosis of enterotoxigenic E. coli infection in low-income countries.

The developing and the testing results of an immunochromatographic test for the D-dimer qualitative determination were presents in the article. The test was approved blood plasma samples in comparison with a quantitative enzyme-linked immunosorbent assay (ELISA). The results of assay with developed test were the same with ELISA results for 87,1% and 100% for samples with increased (more than 400 ng/ml FEU) and normal concentration of D-dimer, respectively. The immunochromatographic test for determination of D-dimer can be included in the diagnostic strategy as a cut test after the assessment of venous thromboembolism risk.

Prevention is the most effective management strategy for influenza A infection in humans. In this study, we developed a CdSe/CdS/ZnS quantum dot (QD) fluorescent dye for rapid and sensitive detection of two common subtypes (H1N1 and H3N2) of influenza A virus, and examined its utility. CdSe/CdS/ZnS QD was conjugated with antibody (Ab) after conjugation with latex, making QD conjugate of QD + Latex + Ab. A stable photoluminescence of QD conjugate and advantage of CdSe/CdS/ZnS QD used was characterized in this study. The performance of a rapid fluorescent immunochromatographic test (FICT) employing QD conjugate (QD-FICT) in detecting influenza A/H1N1 was 8-fold and 64-fold higher than that of a europium nanoparticle-based FICT and a rapid diagnostic test (RDT; Standard Diagnostics BIOLINE Influenza A/B), respectively. For influenza A/H3N2, QD-FICT showed 8-fold and 128-fold higher performance than europium nanoparticle-based FICT and RDT, respectively. In clinical evaluations, QD-FICT showed 93.75% clinical sensitivity [45/48; 95% confidence interval (95% CI): 82.80–98.69], 100% clinical specificity (117/117; 95% CI: 96.90–100.00), and strong correlation (kappa; 0.98) with rRT-PCR (20 ≤ Ct ≤ 40). Europium nanoparticle-linked FICT showed 79.17% clinical sensitivity (38/48; 95% CI: 65.01–89.53) and 100% clinical specificity (117/117; 95% CI: 96.90–100.00), whereas RDT showed 77.08% sensitivity (37/48; 95% CI: 62.69–87.97), 100% specificity (117/117; 95% CI: 96.90–100.00), and reasonably good correlation with rRT-PCR (kappa; 0.93). Water-soluble QDs can therefore be used as an effective material for developing fluorescent diagnostic systems for rapid detection of human influenza A virus in clinical specimens.

Background: Lymphatic filariasis is a debilitating neglected tropical disease that affects impoverished communities. Rapid diagnostic tests of antigenaemia are a practical alternative to parasitological tests of microfilaraemia for mapping and surveillance. However the relationship between these two methods of measuring burden has previously been difficult to interpret.\ud \ud Methods: A statistical model of the distribution of worm burden and microfilariae (mf) and resulting antigenaemic and mf prevalence was developed and fitted to surveys of two contrasting sentinel sites undergoing interventions. The fitted model was then used to explore the relationship in various pre- and post-intervention scenarios.\ud \ud Results: The model had good quantitative agreement with the data and provided estimates of the reduction in mf output due to treatment. When extrapolating the results to a range of prevalences there was good qualitative agreement with published data.\ud \ud Conclusions: The observed relationship between antigenamic and mf prevalence is a natural consequence of the relationship between prevalence and intensity of adult worms and mf production. The method described here allows the estimation of key epidemiological parameters and consequently gives insight into the efficacy of an intervention programme.

Visceral Leishmaniasis (VL) causes high morbidity and mortality in low-to-middle-income countries worldwide. In this study, we used Laser Direct-Write (LDW) technology to develop a new Lateral Flow Device (LFD) with double-channel geometry on a low-cost paper platform as a rapid and accurate serodiagnostic assay for human VL. This Duplex VL-LFD was based on a laser-patterned microfluidic device using two recombinant Leishmania proteins, β-tubulin and LiHyp1, as novel diagnostic antigens. The VL-LFD assay was tested with blood/serum samples from patients diagnosed with VL, Tegumentary Leishmaniasis, Leishmaniasis of unknown identity, other parasitic diseases with similar clinical symptoms, i.e. Leprosy Disease and Chagas Disease, and blood from healthy donors, and compared in parallel with commercial rK39 IT-LEISH® Kit. Clinical diagnosis and real-time Polymerase Chain Reaction assay were used as reference standards. VL-LFD Sensitivity (S ± 95% Confidence Intervals (CI)) of 90.9 (78.9-100) and Specificity (Sp ± 95% CI) of 98.7 (96.1-100) outperformed the IT-LEISH® Kit [S = 77.3 (59.8-94.8), Sp = 94.7 (89.6-99.8)]. This is the first study reporting successful development of an LFD assay using the LDW technology and the VL-LFD warrants comparative testing in larger patient cohorts and in areas with endemic VL in order to improve diagnosis and disease management.

The usefulness of pneumococcal urinary antigen tests (UATs) in severe pneumococcal infection relies heavily on the performance in bacteremic patients. Fluorescence technology and automatic reading of test results may improve UAT performance. We evaluated the automatically read Sofia S. pneumoniae FIA for diagnosing pneumococcal bloodstream infection (BSI) in hospitalized adult patients., The usefulness of pneumococcal urinary antigen tests (UATs) in severe pneumococcal infection relies heavily on the performance in bacteremic patients. Fluorescence technology and automatic reading of test results may improve UAT performance. We evaluated the automatically read Sofia S. pneumoniae FIA for diagnosing pneumococcal bloodstream infection (BSI) in hospitalized adult patients. First, the Sofia FIA was evaluated on 97 patients with pneumococcal (n = 47) and nonpneumococcal (n = 50) BSI and compared with results by the visually read BinaxNOW S. pneumoniae immunochromatographic test (ICT) and ImmuView S. pneumoniae and Legionella pneumophila ICT. In four cases (4.1%), the Sofia FIA showed invalid test results, three of which showed invalid results by the ImmuView ICT previously. Based on 93 valid cases, the Sofia FIA showed similar sensitivity (for both comparisons: 68% versus 62%; P = 0.45) and specificity (for both comparisons: 91% versus 93%; P = 1.00) as the visually read UATs. Second, the Sofia FIA was prospectively evaluated on 82 consecutive nonfrozen urine samples, detecting pneumococcal antigen in 10 of 14 (sensitivity, 71%) pneumococcal BSI patients, similarly to the visually and automatically read BinaxNOW ICT (both 12 of 14; sensitivity, 86%; P = 0.50). Of five nonpneumococcal BSI cases, the Sofia FIA showed an invalid test result in one case, but no positive UAT results were obtained. Thus, the sensitivity and specificity of the Sofia FIA were similar to the performance rates of other UATs in patients with BSI, but invalid test results are of concern for the usefulness in pneumococcal BSI.

Immunochromatographic assays are used by crime laboratories to conduct simple and quick analyses of bodily fluids. These streamlined tests are ideal for decreasing the sexual assault kit backlog in the United States. A large-scale analysis of the frequency of positive results of amylase and prostate specific antigen (PSA) endogenously found in the vaginal cavity was conducted using the SERATEC PSA Semiquant and Amylase tests. Vaginal swabs were self-collected by participants after 7-10 days of no oral contact or male ejaculation. In this study of 50 participants, 98% were negative for PSA and 92% were negative for amylase. Positive results were confirmed to contain no exogenous DNA by male-specific quantitation, short tandem repeat (STR) typing, and Y-STR typing. These results can be used by crime laboratories to help guide interpretation of immunochromatographic test results from vaginal swabs and aid in decision-making in downstream DNA testing.

The KPC K-SeT immunochromatographic test (Coris BioConcept®, Gembloux, Belgium) has been widely used for detection of KPC in Enterobacteriaceae with reported sensitivities and specificities of 100%. However, to our knowledge, there are no reports of its use in KPC-positive Pseudomonas species. We evaluated the KPC K-SeT test in 36 clinical isolates of Enterobacteriaceae (21 KPC-positive and 15 KPC-negative) and 20 Pseudomonas species (5 KPC-positive and 15 KPC-negative) using conventional PCR for carbapenemase genes as the reference method. The KPC K-SeT test detected 25 out of 26 KPC-positive isolates (96.1%). The undetected isolate was 1 P. aeruginosa bearing the mutation D179Y in the omega loop region of KPC-2 carbapenemase. This mutation was already reported in Enterobacteriaceae as conferring resistance to ceftazidime-avibactam. To our knowledge, this is the first report of evaluation of KPC K-SeT test in KPC-positive P. aeruginosa isolates.

Stable and efficient conjugates between antibodies and gold nanoparticles (GNP-Ab) are sought to develop highly sensitive and robust biosensors with applications in medicine, toxicology, food safety controls, and targeted drug delivery. Several strategies have been proposed for directing the antibody attachment to GNPs thus preserving antibody activity, including covalently coupling the antibody to a polymer grafted on GNP surface and exploiting the high affinity of bioreceptors as mediators for the binding. Both approaches also allow for shielding GNPs with a protective layer that guarantees the robustness of the conjugate. Notwithstanding, antibodies freely adsorb to GNP with high binding efficiency. The nonspecific adsorption is far more simple, fast, and inexpensive than any mediated coupling. Therefore, it is preferred for most applications, although it is considered to produce GNP-Ab with a limited activity. In this work, we compared three strategies for producing GNP-Ab, such as (i) covalent coupling mediated by a chemical layer, (ii) affinity-based binding mediated by a biomolecular layer composed of Staphylococcal protein A, and (iii) direct attachment via adsorption. The so-prepared GNP-Ab were employed as probes in a colorimetric lateral flow immunoassay (LFIA) for measuring salivary cortisol as a model biosensor that relies on the use of active GNP-Ab conjugates. Unexpectedly, the biosensors fabricated using the three probes were completely comparable in terms of their ability to measure salivary cortisol. Furthermore, we observed that the sensitivity of the LFIA primarily depended on the amount of the antibody bound to GNPs rather than on the method by which it was bound. The probes prepared using both the direct adsorption approach and mediated coupling via the biochemical mediator enabled development of point-of-care devices for the fast, sensitive, and reliable measurement of human salivary cortisol.

Legionnaires' disease (LD) refers to a serious form of acute pneumonia caused by Legionella species. LD can be difficult to diagnose because the signs and symptoms are nonspecific, and therefore a rapid laboratory diagnosis is of paramount importance. In this study, a recently introduced immunochromatographic test (Immunocatch Legionella; Eiken Chemical Co., Ltd.) for Legionella pneumophila (serogroup 1) urinary antigen detection was compared with the Sofia Legionella fluorescent immunoassay (FIA) (Quidel) (routinely used in our laboratory) and with the widely used BinaxNOW Legionella assay (Alere). A total of 248 urine samples (60 frozen and 188 fresh) were evaluated. All of the samples were collected from patients with high clinical suspicion of Legionnaires' disease. The three assays were performed simultaneously according to the manufacturers' instructions. A total of 180 concordant negative and 66 concordant positive results were obtained. Only 2 discrepant results were registered. The sensitivity and specificity of Immunocatch compared with Sofia were, respectively, 98.5% and 99.4%. Cohen's kappa coefficient and overall percent agreement between Immunocatch and Sofia were also calculated and resulted in, respectively, 0.97 and 99.2%. These performances suggest that the Immunocatch test is a useful tool for Legionella pneumophila (serogroup 1) urinary antigen detection.

The rapid detection of KPC-producing Enterobacteriaceae by microbiology laboratories has been required for infectious control programs. Herein we evaluated the performance of a novel immunochromatographic test for detecting KPC-2-, KPC-3-, KPC-4-, KPC-6-, KPC-7-, KPC-8-, and KPC-11-producing isolates and the influence of different growth media on the test performance.

Rapid immunochromatographic tests (ICT) for dengue non-structural protein 1 (NS1) have shown good performance for diagnosing acute-phase dengue in serum in laboratory settings, but rarely have been assessed in whole blood and at point of care (POC). This study compare the accuracy and inter- and intra-observer reliability of the NS1 Bioeasy™ ICT in whole blood at POC versus serum in the laboratory, during a DENV-1 epidemic. Cross-sectional study involving 144 adults spontaneously demanding care in an emergency department within 4 days of onset of acute febrile illness. Accuracy of NS1 Bioeasy™ ICT was compared in whole blood and serum, both at 15 and 30 min, blinded to the reference RT-PCR or NS1 ELISA. Non-dengue patients were also tested for Zika virus with RT-PCR. Reliability of whole blood and serum readings by the same or different observers was measured by simple kappa (95% CI). At 15 min, sensitivity (Sn) of NS1 Bioeasy™ ICT in whole blood/POC was 76.7% (95% CI: 68.0–84.1) and specificity (Sp) was 87.0% (95% CI: 66.4–97.2). Sn in serum/laboratory was 82% (95% CI: 74.1–88.6) and Sp 100% (95% CI: 85.8–100). Positive likelihood ratio was 5.9 (95% CI: 2.0–17.0) for whole blood/POC and 19.8 (95% CI: 2.9–135.1) for serum/laboratory. Reliability of matched readings of whole blood/POC and serum/laboratory by the same observer (k = 0.83, 95% CI: 0.74–0.93) or different observers (k = 0.81, 95% CI: 0.72–0.92) was almost perfect, with higher discordant levels in the absence of dengue. Results did not differ statistically at 5%. NS1 Bioeasy™ ICT in DENV-1 epidemics is a potentially confirmatory test. Invalid results at 15 min should be reread at 30 min. To optimize impact of implementing ICT in the management of false-negatives it should be incorporated into an algorithm according to setting and available specimen. UTN U1111-1145-9451 .

In this study, the performance of the “RESIST-3 O.K.N. K-SeT” (Coris BioConcept, Gembloux, Belgium) immunochromatographic assay was evaluated in 132 Klebsiella pneumoniae comprising 102 carbapenem resistant and 30 carbapenem susceptible isolates. Genotypically known isolates of Gram negative bacteria ( n = 22) including various species were also tested by the assay as controls. The isolates tested by the immunochromatographic assay and also were run PCR for bla KPC , bla IMP , bla VIM , bla NDM , and bla OXA-48 . The rates of bla NDM , bla OXA-48 , and bla KPC in carbapenem resistant isolates were found at 52.9%, 39.2%, and 2.0%, respectively. Both bla NDM and bla OXA-48 were found in six (5.9%) isolates. The results of the assay showed 100% concordance with those obtained by PCR in 132 K. pneumoniae . The agreement between the two methods was found to be identical at the isolate level. The assay also correctly detected all genotypically known isolates of Escherichia coli , Serratia marcescens , Citrobacter freundii , Enterobacter cloacae , K. pneumoniae carrying bla KPC , bla NDM , and/or bla OXA-48 . On the other hand, the assay did not exhibit any cross-reaction in control isolates harboring bla IMP and bla VIM . We conclude that the RESIST-3 O.K.N. K-SeT is a reliable, rapid, and user friendly test and we recommend it for routine diagnostic laboratories.

Background Foodborne Neglected Zoonotic Helminths (FNZH) are parasites of both economic and public health importance. They include Taenia solium, Echinococcus granulosus sensu lato, Echinococcus multilocularis and Foodborne trematodes (FBT). FNZH are earmarked for major interventions for control, elimination and eradication. This systematic review highlights the progress towards development of rapid tests for the diagnosis of FNZH since 2010 when they were listed as neglected tropical diseases. Methodology A systematic search was conducted in three databases, World of Science, Embase and PubMed using the same search phrase. The search produced 480 hits. Three studies from back referencing were included. Only 22 of these met the inclusion criteria. Data was extracted from these and presented qualitatively. Results Twenty-five rapid diagnostic tests were found to have been developed since 2010, eight for diagnosis of T. solium infections, eight for echinococcosis and nine for FBT infections. The rapid tests for diagnosing T. solium infections included six antibody detecting and two antigen detecting tests. They constitute a combination among them, with some tests providing qualitative, others quantitative results. Similarly, seven out of the eight rapid tests developed for Echinococcus infections were antibody detecting tests save for one loop mediated isothermal amplification test. All of them were qualitative tests. For FBT infections, nine rapid tests were described; two antibody and one nucleic acid detecting test for diagnosis of Fascioliasis; three nucleic acid detecting tests for Opisthorchiasis; one antibody detecting test for Paragonimiasis; and for Clonorchiasis, one antibody and one nucleic acid detecting test. The FBT infection rapid tests were all qualitative in nature. Most of these tests have not undergone field evaluation in endemic areas where they will be used most. Conclusion This review describes the development and evaluation of rapid diagnostic tests, while highlighting the need for in depth validations of the tools to determine how well they can perform in endemic areas.

We evaluated the performance of the RESIST-4 O.K.N.V. assay (Coris) with 98 isolates to detect OXA-48-like and KPC-, NDM-, and VIM-type carbapenemases directly on positive human blood cultures. OXA-48-like and KPC-type isolates were correctly detected, but the detection of NDM- and VIM-type carbapenemases was weak and variable. We show that repeating the test on a 4-h subculture improves the detection of NDM- and VIM-type carbapenemases to 100%.

Background: Leptospirosis is a zoonotic disease of ubiquitous distribution. During rainy seasons, in spring and summer and also during harvest times, the risk of leptospirosis increases as there are chances of frequent contact with infected rat population which is common in Karnataka as farming is a main source of income to the people here. There is a paucity of data regarding the prevalent serovars from Karnataka. This study was undertaken as an attempt to compare a battery of tools such as immunochromatographic test (ICT), microscopic agglutination test (MAT), immunoglobulin M (IgM) enzyme-linked immunosorbent assay (ELISA) and in-house polymerase chain reaction (PCR) to detect leptospirosis. Settings and Design: This study using consecutive sampling technique was conducted in a tertiary care centre, Mysore, Karnataka. Subjects and Methods: Samples from 783 suspected cases of leptospirosis in and around Mysore between April 2013 and April 2016 were processed. Samples from 783 patients suspected of leptospirosis were subjected to ICT, IgM ELISA, MAT and in-house PCR. Statistical Analysis Used: The statistical analysis was carried out using SPSS software version. Results: Among 783 samples tested, only 14 (1.7%) were positive by ICT, 341 (44%) were positive by IgM ELISA, 368 (47%) were positive by MAT and 393 (50.2%) were positive by in-house PCR. Conclusions: Mysore can be considered endemic for leptospirosis. The in-house PCR based on LipL32 gene proved to be useful in the early diagnosis of leptospirosis.

Introduction The standard screening method for alpha thalassaemia is the examination of HbH preparation. It is labour intensive and poorly standardized. The development of a rapid strip immunochromatographic test (ICT) for haemoglobin Barts offers a fast, user friendly and cost‐effective alternative screening tool. Method A total of 180 subjects with results of the thalassaemia screen and genetic testing were included. Results of the ICT and HbH preparation were correlated with genetic results to determine the performance characteristics of the tests and the effect of mean sample age on results. Results Of 180 subjects, 111 carried alpha thalassaemia mutations and 69 participants had normal genetic results. The ICT had a sensitivity of 63.06% for all alpha gene mutations and 100% for both heterozygous alpha0 and HbH disease, with a specificity of 91.30%. Examination of HbH preparation had a sensitivity of 34.23% overall, detecting 89% of heterozygous alpha0 and 100% of HbH disease with a specificity of 98.55%. Sample age did not affect overall results. Conclusions The ICT is a sensitive screening method for significant alpha mutations and detects the majority of homozygous alpha+ and nondeletional mutations. It demonstrates greater correlation with genetic testing than HbH preparation and could replace HbH preparation in the screening algorithm for alpha thalassaemia.

Biosensing platforms for detecting and quantifying biomarkers have played an important role in the past decade. Among them, platforms based on magnetoresistance (MR) sensing technology are attractive. The resistance value of the material changes with the externally applied magnetic field is the core mechanism of MR sensing technology. A typical MR-based sensor has the characteristics of cost-effective, simple operation, high compactness, and high sensitivity. Moreover, using magnetic nanoparticles (MNPs) as labels, MR-based sensors have the ability to overcome the high background noise of complex samples, so they are particularly suitable for point-of-care testing (POCT). However, the problem still exists. How to obtain high-throughput, that is, multiple detections of biomarkers in MR-based sensors, thereby improving detection efficiency and reducing the burden on patients is an important issue in future work. This paper reviews three MR-based detection technologies for the detection of biomarkers, i.e., anisotropic magnetoresistance (AMR), giant magnetoresistance (GMR), and tunneling magnetoresistance (TMR). Based on these three common technologies, different typical applications that include biomedical diagnosis, food safety, and environmental monitoring are presented. Furthermore, the existing MR-based detection method is better expanded to make it more in line with present detection needs by combining different advanced technologies including microfluidics, Microelectromechanical systems (MEMS), and Immunochromatographic test strips (ICTS). And then, a brief discussion of current challenges and perspectives of MR-based sensors are pointed out.

Background/aim: The prevalences of Plasmodium falciparum and Plasmodium vivax are increasing rapidly in Pakistan, but recent data on the epidemiology of malaria are not properly reported with scarce diagnostic methods for quick diagnosis. This study was designed to determine the current prevalence and distribution of Plasmodium species in the vicinity of Rawalpindi and Islamabad and report on the validity of the immunochromatographic test (ICT) in diagnosing malarial infections. Materials and methods: A total of 1500 blood samples obtained from a local hospital were screened during the course of this study via microscopic examination and ICT. Results: It was seen that malaria was highly endemic in this region. Both P. vivax and P. falciparum were prevalent in all age groups with high seasonal variations, showing a summer peak for P. vivax and a winter peak for P. falciparum. In a comparative study of the diagnostic methods it was observed that the ICT is 95% sensitive and 100% specific for both P. falciparum and P. vivax, while microscopic study was 100% sensitive and 96.8% specific. Conclusion: Epidemiological study of the malarial parasites showed that majority of the patients were from Rawalpindi as compared to Islamabad and that P. vivax was the dominant cause of malarial infection.

Objective To develop and optimize a rapid molecular method for diagnosing campylobacteriosis directly from a clinical fecal sample and at the same time for determining the most common causing agents - C. jejuni/coli. Materials and methods 38 clinical fecal samples from hospitalized patients with diarrheal syndrome were tested using a rapid immunochromatographic test. All positive samples were tested for confirmation by culturing in a microaerophilic atmosphere. The Eva Green real-time mPCR reaction of a direct fecal sample was conducted using the "IQ5TM Real-Time PCR System" apparatus. Results Out of 38 clinical fecal samples which were ICT positive, 18 strains were isolated by culture, namely, 17 of C. jejuni and 1 of C. coli. The Eva Green real-time mPCR reaction also reported 18 positive samples for Campylobacter, out of which 17 were of C. jejuni and only one of C.coli. Conclusion We developed and optimized the Eva Green real-time mPCR for the detection and species differentiation of C. jejuni/coli directly from a clinical fecal sample. The molecular analysis we described has a 100% sensitivity and specificity when comparing the results obtained by it to those of the culture method, which is currently the "gold standard" in the diagnosis of campylobacteriosis (Tab. 2, Fig. 1, Ref. 6).

Background . Viral infections are recognized as the most common cause of acute gastroenteritis (AGE). Virus detection by immune analytical methods is recommended for diagnosis because of its simplicity and low cost. Objectives . Two commercial immunochromatographic (ICG) techniques (Materlab) for rapid detection of rotavirus/adenovirus and norovirus respectively, were evaluated by comparison to the results obtained using PCR methods. In addition, clinical and epidemiologic characteristics of AGE infections have been described. Study design . A total of 100 faecal samples collected from patients with AGE (84% children) admitted into a Spanish Hospital between February and July 2018, were studied for rotavirus-A, adenovirus and norovirus GI/GII by the ICG tests as well as by PCR and sequencing. Other enteric viruses (enterovirus and astrovirus) were investigated by PCR methods. Gastrointestinal bacteria and parasites were also tested. Results . Evaluated ICG tests yielded high specificity (>97%). Sensitivity values were high for rotavirus/adenovirus (>80%) but lower for norovirus (57%). Overall, and taking into account coinfections, viruses (32%), bacteria (14%) and parasites (1%) could be detected. Rotavirus-A were the most frequently identified viruses (16%), followed by enterovirus (12%), norovirus (4%), adenovirus 41 (4%) and astrovirus (1%). In five vaccinated children, a rotavirus was detected. Conclusions . ICG technique is a useful tool for the routine diagnosis of AGE infections at hospital, but for surveillance and epidemiological studies, it is needed the use of amplification and sequencing methods, which also allow monitoring of new strains or variants emergence. In this study, an etiological pathogen was determined only in 44% of samples.