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Current guidelines for patient isolation in COVID-19 cases recommend a symptom-based approach, averting the use of control real-time reverse transcription PCR (rRT-PCR) testing. However, we hypothesized that patients with persistently positive results by RT-PCR for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) could be potentially infectious for a prolonged time, even if immunocompetent and asymptomatic, which would demand a longer social isolation period than presently recommended. To test this hypothesis, 72 samples from 51 mildly symptomatic immunocompetent patients with long-lasting positive rRT-PCR results for SARS-CoV-2 were tested for their infectiousness in cell culture. The serological response of samples from those patients and virus genomic integrity were also analyzed. Infectious viruses were successfully isolated from 34.38% (22/64) of nasopharynx samples obtained 14 days or longer after symptom onset. Indeed, we observed successful virus isolation up to 128 days. Complete SARS-COV-2 genome integrity was demonstrated, suggesting the presence of replication-competent viruses. No correlation was found between the isolation of infectious viruses and rRT-PCR cycle threshold values or the humoral immune response. These findings call attention to the need to review current isolation guidelines, particularly in scenarios involving high-risk individuals. IMPORTANCE In this study, we evaluated mildly symptomatic immunocompetent patients with long-lasting positive rRT-PCR results for SARS-CoV-2. Infectious viruses were successfully isolated in cell cultures from nasopharynx samples obtained 14 days or longer after symptom onset. Indeed, we observed successful virus isolation for up to 128 days. Moreover, SARS-CoV-2 genome integrity was demonstrated by sequencing, suggesting the presence of replication-competent viruses. These data point out the risk of continuous SARS-CoV-2 transmission from patients with prolonged detection of SARS-CoV-2 in the upper respiratory tract, which has important implications for current precaution guidelines, particularly in settings where vulnerable individuals may be exposed (e.g., nursing homes and hospitals).

BACKGROUND The high demand for adequate material for the gold standard reverse transcription real-time polymerase chain reaction (RT-qPCR)-based diagnosis imposed by the Coronavirus disease 2019 (COVID-19) pandemic, combined with the inherent contamination risks for healthcare workers during nasopharyngeal swab (NP) sample collection and the discomfort it causes patients, brought the need to identify alternative specimens suitable for the diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). OBJECTIVES The aim of this work was to compare saliva and gingival fluid swabs to NP swabs as specimens for RT-qPCR-based SARS-CoV-2 diagnosis. METHODS We compared gingival fluid swabs (n = 158) and saliva (n = 207) to the rayon-tipped NP swabs obtained from mild-symptomatic and asymptomatic subjects as specimens for RT-qPCR for SARS-CoV-2 detection. FINDINGS When compared to NP swabs, gingival fluid swabs had a concordance rate of 15.4% among positive samples, zero among inconclusive, and 100% among negative ones. For saliva samples, the concordance rate was 67.6% among positive samples, 42.9% among inconclusive, and 96.8% among negative ones. However, the concordance rate between saliva and NP swabs was higher (96.9%) within samples with lower cycle threshold (Ct) values (Ct > 10 ≤ 25). MAIN CONCLUSIONS Our data suggests that whereas gingival fluid swabs are not substitutes for NP swabs, saliva might be considered whenever NP swabs are not available or recommended.

Accurate serological tests are essential tools to allow adequate monitoring and control of COVID-19 spread. Production of a low-cost and high-quality recombinant viral antigen can enable the development of reliable and affordable serological assays, which are urgently needed to facilitate epidemiological surveillance studies in low-income economies. Trimeric SARS-COV-2 spike (S) protein was produced in serum-free, suspension-adapted HEK293 cells. Highly purified S protein was used to develop an ELISA, named S-UFRJ test. It was standardized to work with different types of samples: (i) plasma or serum from venous blood samples; (ii) eluates from dried blood spots (DBS) obtained by collecting blood drops from a finger prick. We developed a cost-effective, scalable technology to produce S protein based on its stable expression in HEK293 cells. Using this recombinant antigen, we presented a workflow for test development in the setting of a pandemic, starting from limited amounts of samples up to reaching final validation with hundreds of samples. Test specificity was determined to be 98.6%, whereas sensitivity was 95% for samples collected 11 or more days after symptoms onset. A ROC analysis allowed optimizing the cut-off and confirming the high accuracy of the test. Endpoint titers were shown to correlate with virus neutralization assessed as PRNT90. There was excellent agreement between plasma and DBS samples, significantly simplifying sample collection, storing, and shipping. An overall cost estimate revealed that the final retail price could be in the range of one US dollar. The S-UFRJ assay developed herein meets the quality requirements of high sensitivity and specificity. The low cost and the use of mailable DBS samples allow for serological surveillance and follow-up of SARS-CoV-2 vaccination of populations regardless of geographical and socio-economic aspects. We hope the detailed guidelines for the development of an affordable and accurate anti-spike SARS-COV-2 ELISA, such as S-UFRJ described here, will stimulate governmental and non-governmental health agencies in other countries to engage in much-needed large-scale studies monitoring the spread and immunity to SARS-COV-2 infection.

Introduction In the current standard of care (SoC) RT-PCR method for COVID-19, the patient's swab was extracted in viral transport media (VTM). For the Panbio™ COVID-19 Ag Rapid Test, the patient swab is flushed out in extraction buffer, of which a small fraction is used for testing, leaving more than half the sample unused. This study was designed to show that RT-PCR results from the residual sample of the Panbio™ COVID-19 Ag Rapid Test (called Novel RT-PCR) are not worse than the SoC RT-PCR result. Methods The study was performed using (1) dilution series of five patient samples, and (2) 413 patient samples comparing SOC versus Novel RT-PCR results. Results For the dilution series samples, all tested positive by both methods. The bias between Ct values of Novel RT-PCR and SoC RT-PCR did not exceed 3.00 Ct using primers N1 and N2. A total of 413 COVID symptomatic patients seeking COVID testing were tested, of which 89 patients tested positive and 324 tested negative with SoC RT-PCR. In 324 patients who tested negative with SoC RT-PCR, 323 tested negative with Novel RT-PCR, and one (1) tested positive. Out of 89 who tested positive with SoC RT-PCR, 80 tested positive with the Novel RT-PCR, and nine patients showed a negative test result. The Overall Percent Agreement for the 413 valid patient sample pairs was 97.5 [95% CI 97 to 98]. Conclusion The study demonstrated that the performance of the Novel RT-PCR method is acceptable compared to the SoC RT-PCR method and can be a useful tool to perform RT-PCR without the need for new swab collections.

Introduction: Infections caused by the hepatitis B virus (HBV) and hepatitis C virus (HCV) are a major public health problem. Objectives: The study aimed to detect HBsAg, anti-HBc, anti-HBs and anti-HCV among health professionals and users of the Brazilian Unified Health System [Sistema Único de Saúde (SUS)] in the city of Resende, Rio de Janeiro, and to describe the sociodemographic profile and background of exposure. Methods: A total of 585 samples were collected between May and June 2014, obtained from the Brazilian Notifiable Diseases Surveillance System [Sistema de Informação de Agravos de Notificação (SINAN)] data, which were tested for HBsAg, anti-HBc, anti-HBs and anti-HCV. Results: The predominant age group observed was 30-44 years (n = 277; 47.3%), 54.87% (n = 321) were female and 271 (46.32%) self declared skin colour/ethnicity white. The married participants were 262 (44.78%), 42.22% graduated from high school (n = 247) and 174 were health professionals (29.74%). Four participants were anti-HCV reagents and 18 were anti-HBc reagents. From these, 15 participants were reactive for anti-HBs antibodies. Among health professionals, 68.8% were anti-HBs positive. And 63.9% of participants declared to be vaccinated against hepatitis B. Conclusion: The prevalence of 0.68% for HCV and 3.08% for anti-HBc are below that detected in the Southeast region from the last census in the capitals of Brazil. There is still a reduced acceptance among health professionals for HBV and HCV screening. RESUMO Introdução: As infecções causadas pelo vírus da hepatite B (VHB) e C (VHC) constituem grave problema de saúde pública. Objetivos: O estudo visou detectar os marcadores HBsAg, anti-HBc, anti-HBs e anti-VHC em profissionais de saúde e usuários do Sistema Único de Saúde (SUS) no município de Resende, Rio de Janeiro, bem como descrever o perfil sociodemográfico e os antecedentes de exposição. Métodos: Foram avaliadas 585 amostras entre maio e junho de 2014, obtidas dos dados do Sistema de Informação de Agravos de Notificação (SINAN). Elas foram testadas para HBsAg, anti-HBc, anti-HBs e anti-VHC. Resultados: A faixa etária predominante observada foi de 30-44 anos (n = 277; 47,3%); 54,87% (n = 321) eram do sexo feminino e 271 (46,32%) se autodeclararam de cor da pele/etnia branca. Os participantes casados foram 262 (44,78%); 42,22% tinham o ensino médio (n = 247) e 174 eram profissionais de saúde (29,74%). Quatro participantes eram anti-VHC reagentes e 18, reagentes para anti-HBc. Destes, 15 eram anti-HBs reagentes (aHBs+). Nos profissionais de saúde, 68,8% possuem aHbs+. Em relação à vacinação contra hepatite B, 63,9% declararam possuí-la. Conclusão: As prevalências 0,68% de VHC e de 3,08% de anti-HBc estão abaixo da detectada na região Sudeste no último censo nas capitais do Brasil. Há ainda reduzida adesão dos profissionais de saúde à testagem para VHB e VHC.

We describe a cost-effective, scalable technology to produce SARS-COV-2 spike (S) protein based on stable expression in HEK293 cells, and its use to develop a highly specific and sensitive ELISA test. The assay allows early detection of anti-S IgG seroconversion and endpoint titers correlate with virus neutralization. The low-cost S-antigen production, together with sample collection by finger prick and dried blood spots, allowed the development of a half-dollar test that fits the urgent need for large-scale serological surveillance in low-income countries.

PROBLEM Pregnancy appears to favor maternal antibody production. In contrast, by damaging follicular helper T cells (TFH ), HIV-1 infection compromises protective humoural immune response. Therefore, we aimed to investigate the frequency of different TFH -like cells in HIV-infected pregnant women (PW) before and after antiretroviral (ARV) therapy. METHOD OF STUDY Peripheral blood mononuclear cells, CD4+ T and B cells, were obtained from asymptomatic HIV-1-infected non-PW and PW just before and after ARV therapy. In some experiments, healthy HIV-1-negative PW were also tested. The frequency of different TFH -like cell subsets was determined by flow cytometry. The plasma titers of IgG anti-tetanus toxoid (TT), anti-HBsAg, and anti-gp41 were determined by ELISA. The in vitro production of total IgG, IL-21, and hormones (estrogen and progesterone) was quantified also by ELISA. RESULTS Our results demonstrate that antiretroviral (ARV) therapy was more efficient in elevating the percentage of circulating IL-21-secreting TFH cells in HIV-1-infected pregnant women (PW) than in non-pregnant patients (nPW). Moreover, in co-culture systems, CD4+ T cells from ART-treated PW were more efficient in assisting B cells to produce IgG production. The in vivo anti-HBsAg IgG titers after ARV therapy were also significantly higher in PW, and their levels were directly associated with both IL-21+ TFH frequency and plasma concentration of estrogen. CONCLUSION In summary, our results suggest that pregnancy favors the recovery of TFH -like cells after ARV therapy in HIV-1-infected women, which could help these mothers to protect their newborns from infectious diseases by transferring IgG across the placenta.

Background A new point-of-care (POC) HIV virus load technology has been recently developed and designed to be utilized in decentralized settings. Alere Technologies GmbH*, Germany, developed the mPIMA HIV-1/2 VL plasma test which uses real time PCR technology with 50 μl and a turnaround time of one hour. Objective Analyze the performance of mPIMA to detect and quantify HIV-1 and HIV-2 and compare with Abbott M2000 assay fooling patients HIV-1 failing ARV therapy. Study design In this study we evaluate the mPIMA HIV-1/2 VL plasma test using 413 specimens from 270 patients failing ARV therapy, and compared its performance with Abbott RealTime HIV-1 Viral Load assay on the m2000 system. In addition, were determined VL in plasma specimens obtained from HIV-2 infected patients. Results The results strongly indicate that mPIMA HIV-1/2 VL plasma test can determine HIV-1 with concordance of 88.9 % (95 % CI 85.4–91.7) the reference test when 1000 HIV-1 VL threshold was used as WHO cutoff to identify therapy failure. The overall correlation between HIV-1 VL was 0928 (Pearson correlation coefficient of Linear regression) and the Bland-Altman showed a mean difference of -0.20 Log cp/mL between the two technology. mPIMA HIV-1/2 VL plasma test was also able to measure HIV-2 viral load in 16 specimens from Guinea-Bissau HIV-1/HIV-2 positive samples. Conclusions These data support the use of mPIMA HIV-1/2 VL plasma test to follow up patients and select patients failing ART, guiding immediate clinical decisions such as adherence counseling or ART regimen switch during the patient consultation.

Hospital Federal dos Servidores do Estado. Infectious Diseases Department. Rio de Janeiro, RJ, Brazil. Universidade Federal do Rio de Janeiro. Instituto de Biologia. Departamento de Gen?tica. Laborat?rio de Biologia Molecular. Rio de Janeiro, RJ, Brazil. Hospital Federal dos Servidores do Estado. Infectious Diseases Department. Rio de Janeiro, RJ, Brazil / Funda??o Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil. Hospital Federal dos Servidores do Estado. Infectious Diseases Department. Rio de Janeiro, RJ, Brazil / Funda??o Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brazil. Universidade Federal do Rio de Janeiro. Instituto de Biologia. Departamento de Gen?tica. Laborat?rio de Biologia Molecular. Rio de Janeiro, RJ, Brazil. Universidade Federal do Rio de Janeiro. Instituto de Biologia. Departamento de Gen?tica. Laborat?rio de Biologia Molecular. Rio de Janeiro, RJ, Brazil. Universidade Federal do Rio de Janeiro. Instituto de Biof?sica Carlos Chagas Filho. Laborat?rio de Gen?mica Estrutural. Rio de Janeiro, RJ, Brazil. Universidade Federal do Rio de Janeiro. Instituto de Biof?sica Carlos Chagas Filho. Laborat?rio de Gen?mica Estrutural. Rio de Janeiro, RJ, Brazil. Universidade Federal do Rio de Janeiro. Instituto de Biologia. Departamento de Gen?tica. Laborat?rio de Biologia Molecular. Rio de Janeiro, RJ, Brazil. Minist?rio da Sa?de. Secretaria de Vigil?ncia em Sa?de. Instituto Evandro Chagas. Ananindeua, PA, Brasil. Hospital Federal dos Servidores do Estado. Infectious Diseases Department. Rio de Janeiro, RJ, Brazil. Hospital Federal dos Servidores do Estado. Maternal-Fetal Unit. Rio de Janeiro, RJ, Brazil. University of California at San Francisco. Department of Epidemiology and Biostatistics. San Francisco, California, United States of America. BACKGROUND: Zika virus (ZIKV) was first isolated in Uganda in 1947. In Brazil, the first reported case of ZIKV infection was in May 2015. Additionally, dengue (DENV) is endemic and there has been a recent outbreak of chikungunya (CHIKV). Since the clinical manifestations of different arboviral infections (AI) can be similar, definitive diagnosis requires laboratory testing. OBJECTIVES: To determine the prevalence of ZIKV, DENV, and CHIKV infections in a Brazilian cohort of HIV-infected pregnant women, to assess clinical/immunological characteristics and pregnancy outcomes of women with evidence of recent AI. STUDY DESIGN: Laboratory diagnosis of ZIKV, DENV and CHIKV infections utilized serological assays, RT-PCR and PRNT. The tests were performed at the first visit, 34-36 weeks of gestation and at any time if a woman had symptoms suggestive of AI. Mann-Whitney tests were used for comparison of medians, Chi-square or Fisher's to compare proportions; p< 0.05 was considered statistically significant. Poisson regression was used to analyze risk factors for central nervous system (CNS) malformations in the infant according to maternal symptomatology. RESULTS: Of 219 HIV-infected pregnant women enrolled, 92% were DENV IgG+; 47(22%) had laboratory evidence of recent AI. Of these, 34 (72%) were ZIKV+, nine (19%) CHIKV+, and two (4%) DENV+. Symptoms consistent with AI were observed in 23 (10%) women, of whom 10 (43%) were ZIKV+, eight (35%) CHIKV+. No CNS abnormalities were observed among infants of DENV+ or CHIKV+ women; four infants with CNS abnormalities were born to ZIKV+ women (three symptomatic). Infants born to ZIKV+ women had a higher risk of CNS malformations if the mother was symptomatic (RR = 7.20), albeit not statistically significant (p = 0.066). CONCLUSIONS: Among HIV-infected pregnant women with laboratory evidence of a recent AI, 72% were ZIKV-infected. In this cohort, CNS malformations occurred among infants born to both symptomatic and asymptomatic pregnant women with Zika infection.

Zika virus (ZIKV) disease has become a global health emergency with devastating effects on public health. Recent evidences implicate the virus as an emergent neuropathological agent promoting serious pathologies of the human nervous system, that include destructive and malformation consequences such as development of ocular and fetal brain lesions, microcephaly in neonates, and Guillain–Barré syndrome (GBS) in adults. These neurological disorders of both central and peripheral nervous systems are thought to be associated to the neurotropic properties of the virus that has ability to infect neural stem cells as well as peripheral neurons, a hallmark of its pathogenicity. The presence of autoantibodies against gangliosides plays a pivotal role in the etiogenesis of GBS and a variety of neurological disorders. Gangliosides are a class of galactose-containing cerebrosides mainly expressed in nervous system tissues playing a critical role in the physiology of neural cells and neurogenesis. Herein, our findings indicate that patients at acute phase of ZIKV infection without any neurological signs show increased levels of IgG autoantibody against GD3 gangliosides, a class of glycolipid found to be highly expressed in neural stem cell acting in the maintenance of their self-renewal cellular capacity. It is possible that a pathological threshold of these antibodies is only acquired in secondary or subsequent infections. In the light of these evidences, we propose that the target of GD3 by autoimmune responses may possibly has an effect in the neuropathy and neurogenesis disorder seen during ZIKV infection.

Background: This paper describes the transmission of hepatitis A virus (HAV) to two blood recipients from a healthy donor that later presented to the blood bank with jaundice. Methods: The RNA of HAV was detected by qualitative nested reverse transcription polymerase chain reaction (nested RT-PCR) and quantified by real-time RT-PCR. HAV RNA samples were genotyped by direct sequencing of PCR products. A sequence from a fragment of 168 bp from the VP1/2A HAV region was used to construct a phylogenetic tree. Case Report: A 31-year-old male donor accepted for donation of a whole blood unit returned to the blood bank with clinical jaundice 20 days after donation. His serological and NAT tests were negative for HBV and HCV. Serological tests for HAV IgM and IgG were negative on donation sample but positive on follow-up sample, confirming donor's HAV acute infection. Both recipients of red blood cells (R1) and platelet concentrate (R2) from the same implicated donation were HAV IgM-negative and IgG-positive. Qualitative PCR was positive on samples from all three individuals and phylogenetic analysis of viruses proved HAV transmission to the two recipients of blood products. HAV viral load on donor follow-up sample and the platelet recipient was 1.3 and 1.5 × 103 IU/ml, respectively. The RBC recipient, also infected by HCV, was undergoing bone marrow transplantation and died from fulminant hepatitis, 26 days after the implicated HAV transfusion. Conclusion: The blood donor, a garbage collector, spontaneously returned to the blood bank when developing jaundice. This highlights the importance of donor education to immediately report to blood banks of any signs and symptoms related to infectious disease developed after blood donation. The fact that one immunocompromised patient with HCV infection died from fulminant hepatitis after receiving a HAV-contaminated platelet transfusion underpins the importance of a HAV vaccination program for these group of patients.

Background and rationale. Epidemics of hepatitis B and C are a public health burden, and their prevalence in Brazil varies among regions. We determined the prevalence of hepatitis markers in an urban university population in order to support the development of a comprehensive program for HBV immunization and HBV/HCV diagnosis. Students, employees, and visitors (n = 2,936, 31 years IQR 24.5-50, female = 69.0% and 81.1% with at least 12 years of education) were enrolled from May to November 2013. Antibodies against hepatitis B surface antigen (anti-HBs), against hepatitis B core antigen (anti-HBc), and hepatitis B surface antigen (HBsAg) were detected with enzyme immunoassays and anti-hepatitis C virus (anti-HCV) antibodies with a chemiluminescence immunoassay. The results were confirmed with polymerase chain reaction for HCV and nucleic acid amplification test for hepatitis B virus (HBV). Results. The overall prevalence of markers among the participants was 0.136% (95% confidence interval [CI]: 0.003-0.270) for HBsAg, 6.44% (95% CI: 5.55-7.33%) for anti-HBc, 50.8% (95% CI: 48.9-52.7%) for anti-HBs > 10 mIU/mL, and 0.44% (95% CI: 0.20-0.68) for anti-HCV. Almost 30.4% had anti-HBs titers > 100 mIU/mL. Participants with a detectable HCV viral load (n = 9) were infected with genotype 1a. Conclusions. In an urban university population, in which 80% of participants had > 11 years of education, prevalence increased with age, and self-declared ethnicity for anti-HBc and with age, marital status and professional activity for anti-HCV antibodies. A periodical offer of HCV rapid testing should be implemented, and HBsAg rapid testing should be offered to individuals above 20 years of age.

The point-of-care tests (POCTs) for HIV diagnosis have been widely used in Brazil in order to expand and to allow HIV diagnosis outside health units including remote areas, such as the Amazon region. In order to guarantee the quality of HIV diagnostics based on rapid tests, the Brazilian Ministry of Health (MoH) implemented the HIV POCT Evaluation Program. This study compiles the Brazilian experience acquired over the last 13 years conducting the HIV POCT Evaluation Program. Methods and Findings The selection of tests was based on the interest of manufacturers to qualify for the MoH tenders. Each round was performed with fresh whole blood and oral fluid samples, always including HIV positive and negative ones. In addition to the POCT, every sample was submitted to a reference testing protocol, based on an immunoassay followed by Western blot. The POCTs were evaluated for clinical sensitivity, clinical specificity, assay operational characteristics, detection of HIV-2 antibodies, sensitivity to subtypes panels; and sensitivity to seroconversion panels. Since its implementation in 2003, the POCT evaluation protocol has undergone some modifications aiming to improve and simplify the evaluation process, to know: (i) for HIV-positive samples, perform EIA and Western blot only if the POCT is non-reactive; (ii) reduction from 800 to 600 HIV negative samples; (iii) increase from one to three subtype panels (including HIV-2 samples); and (iv) inclusion of seroconversion panel. We evaluated six tests, four of which met the sensitivity criteria of 99.5%: BD Chek™ HIV Multi-test (whole blood), HIV 1/2 Colloidal Gold (whole blood), OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test (whole blood and oral fluid) and TR DPP HIV-1/2 (whole blood, plasma and oral fluid). Regarding other evaluated criteria, all assays met the requirements. Conclusions The successful Brazilian policy on POCT use for HIV infection diagnosis includes the evaluation of the POCT itself in addition to appropriate selection of tests to be acquired and nationwide distributed to the public health facilities, control of each test batch distributed by the MoH, proper and easily accessible training to all health professionals involved in rapid testing through distance learning tools, and continued evaluation of POCT use through external quality assessment.

We read the letter from Colavita, et al 1, where the authors show by in vitro experiments that human osteoblast-like SV-40 T antigen immortalized (HOBIT) cells are productively infected by Zika virus (ZIKV). Their experiments with HOBIT cells infected with both Asian and African Zika strains show that both viruses are indeed able to produce a fair amount of virus 96 h postinfection. It is interesting that ZIKV could replicate in a HOBIT … Address correspondence to Dr. L. Roimicher, Department of Rheumatology–Internal Medicine, Hospital Universitario CFF, Universidade Federal do Rio de Janeiro, Rua Prof Rodolpho Paulo Rocco 255, 70 Andar, Rio de Janeiro, Brazil. E-mail: mail-luizroimicher{at}gmail.com

The importance of metrological traceability in the manufacture of diagnostic kits is not well understood in the laboratory community. Therefore, its influence on method validation and the production of accurate and comparable results in clinical laboratories is rarely discussed. This study aims to contribute to the dissemination of the knowledge of metrological traceability and emphasize the importance of using Certified Reference Materials (CRMs) or reference methods (RFs) during the manufacture of diagnostic kits. According to our study, metrological traceability was exclusively demonstrated through the use of CRMs in 57% of cases and through that of RFs in 26% of cases. For the diagnostic kits that used CRMs during the manufacturing process, the CRMs were sourced exclusively from NIST (National Institute of Standards and Technology). Other results of the study indicate that 46% of the diagnostic kits reported to be used in the proficiency testing program at ControlLab - Biochemistry are produced in Brazil, which demonstrates the importance of the national industry. However, with respect to metrological traceability, 14% of the 121 diagnostic kits surveyed did not inform about metrological traceability, and all of them were manufactured in Brazil. This suggests that some Brazilian manufacturers are not attentive to the dissemination of metrological traceability information as a means of attesting to the quality of their product.

To the Editor: Since 2015, Brazil has experienced a major public health crisis caused by the arboviruses Zika (ZIKV) and Chikungunya (CHIKV), which are circulating along with the dengue virus1. ZIKV is now considered endemic in all Brazilian states and is currently spreading widely in South and Central America and is threatening the United States and Europe2,3. ZIKV and CHIKV share similar acute clinical presentation with arthralgia, skin rash, and fever, which also resembles other rheumatic diseases1,4. Most relevantly, ZIKV and CHIKV may complicate the clinical condition of rheumatic patients. We share here the case of a 53-year-old woman with a … Address correspondence to Dr. L. Roimicher, Department of Rheumatology–Internal Medicine, Hospital Universitario CFF, Universidade Federal do Rio de Janeiro, Rua Prof Rodolpho Paulo Rocco 255, 70 Andar, Rio de Janeiro, Brazil. E-mail: mail-luizroimicher{at}gmail.com

Introduction: Prevention of acute HIV infections in pregnancy is required to achieve elimination of pediatric HIV. Identification and support for HIV negative pregnant women and their partners, particularly serodiscordant couples, are critical. A mixed method study done in Southern Mozambique estimated HIV incidence during pregnancy, associated risk factors and factors influencing partner's HIV testing. Methods: Between April 2008 and November 2011, a prospective cohort of 1230 HIV negative pregnant women was followed during pregnancy. A structured questionnaire, HIV testing, and collection of dried blood spots were done at 2-3 scheduled visits. HIV incidence rates were calculated by repeat HIV testing and risk factors assessed by Poisson regression. A qualitative study including 37 individual interviews with men, women, and nurses and 11 focus group discussions (n=94) with men, women and grandmothers explored motivators and barriers to uptake of male HIV testing. Results: HIV incidence rate was estimated at 4.28/100 women-years (95% CI: 2.33-7.16). Significant risk factors for HIV acquisition were early sexual debut (RR 3.79, 95% CI: 1.04-13.78, p=0.04) and living in Maputo Province (RR 4.35, 95% CI: 0.97-19.45, p=0.05). Nineteen percent of women reported that their partner had tested for HIV (93% knew the result with 8/213 indicating an HIV positive partner), 56% said their partner had not tested and 19% did not know their partner test status. Of the 14 seroconversions, only one reported being in a serodiscordant relationship. Fear of discrimination or stigma was reported as a key barrier to male HIV testing, while knowing the importance of getting tested and receiving care was the main motivator. Conclusions: HIV incidence during pregnancy is high in Southern Mozambique, but knowledge of partners' HIV status remains low. Knowledge of both partners' HIV status is critical for maximal effectiveness of prevention and treatment services to reach elimination of pediatric HIV/AIDS.

Introduction : Acute infection with HIV in the postpartum period results in a high risk of vertical transmission through breastfeeding. A study was done to determine the HIV incidence rate and associated risk factors among postpartum women in Southern Mozambique, where HIV prevalence among pregnant women is 21%. Methods : A prospective cohort study was conducted in six rural health facilities in Gaza and Maputo provinces from March 2008 to July 2011. A total of 1221 women who were HIV-negative on testing at delivery or within two months postpartum were recruited and followed until 18 months postpartum. HIV testing, collection of dried blood spot samples and administration of a structured questionnaire to women were performed every three months. Infant testing by DNA-PCR was done as soon as possible after identification of a new infection in women. HIV incidence was estimated, and potential risk factors at baseline were compared using Poisson regression. Results : Data from 957 women were analyzed with follow-up after the enrolment visit, with a median follow-up of 18.2 months. The HIV incidence in postpartum women is estimated at 3.20/100 women-years (95% CI: 2.30–4.46), with the highest rate among 18- to 19-year-olds (4.92 per 100 women-years; 95% CI: 2.65–9.15). Of the new infections, 14 (34%) were identified during the first six months postpartum, 11 (27%) between 6 and 12 months and 16 (39%) between 12 and 18 months postpartum. Risk factors for incident HIV infection include young age, low number of children, higher education level of the woman's partner and having had sex with someone other than one's partner. The vertical transmission was 21% (95% CI: 5–36) among newly infected women. Conclusions : Incidence of HIV is high among breastfeeding women in Southern Mozambique, contributing to increasing numbers of HIV-infected infants. Comprehensive primary prevention strategies targeting women of reproductive age, particularly pregnant and postpartum women and their partners, will be crucial for the elimination of paediatric AIDS in Africa. Keywords: PMTCT; breastfeeding; incidence; HIV; elimination paediatric HIV; Mozambique. To access the supplementary material to this article please see Supplementary Files in the column to the right (under Article Tools) (Published: 5 March 2014) Citation: De Schacht C et al. Journal of the International AIDS Society 2014, 17 :18808 http://www.jiasociety.org/index.php/jias/article/view/18808 | http://dx.doi.org/10.7448/IAS.17.1.18808

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ) Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) Prefeitura Municipal de Campina Grande IMPORTANCE Recent studies have reported an increase in the number of fetuses and neonates with microcephaly whose mothers were infected with the Zika virus (ZIKV) during pregnancy. To our knowledge, most reports to date have focused on select aspects of the maternal or fetal infection and fetal effects. OBJECTIVE To describe the prenatal evolution and perinatal outcomes of 11 neonates who had developmental abnormalities and neurological damage associated with ZIKV infection in Brazil. DESIGN, SETTING, AND PARTICIPANTS We observed 11 infants with congenital ZIKV infection from gestation to 6 monthus in the state of Paraba, Brazil. Ten of 11 women included in this study presented with symptoms of ZIKV infection during the first half of pregnancy, and all 11 had laboratory evidence of the infection in several tissues by serology or polymerase chain reaction. Brain damage was confirmed through intrauterine ultrasonography and was complemented by magnetic resonance imaging. Histopathological analysis was performed on the placenta and brain tissue from infants who died. The ZIKV genome was investigated in several tissues and sequenced for further phylogenetic analysis. MAIN OUTCOMES AND MEASURES Description of the major lesions caused by ZIKV congenital infection. RESULTS Of the 11 infants, 7 (63.6%) were female, and the median (SD) maternal age at delivery was 25 (6) years. Three of 11 neonates died, giving a perinatal mortality rate of 27.3%. The median (SD) cephalic perimeter at birth was 31 (3) cm, a value lower than the limit to consider a microcephaly case. In all patients, neurological impairments were identified, including microcephaly, a reduction in cerebral volume, ventriculomegaly, cerebellar hypoplasia, lissencephaly with hydrocephalus, and fetal akinesia deformation sequence (ie, arthrogryposis). Results of limited testing for other causes of microcephaly, such as genetic disorders and viral and bacterial infections, were negative, and the ZIKV genome was found in both maternal and neonatal tissues (eg, amniotic fluid, cord blood, placenta, and brain). Phylogenetic analyses showed an intrahost virus variation with some polymorphisms in envelope genes associated with different tissues. CONCLUSIONS AND RELEVANCE Combined findings from clinical, laboratory, imaging, and pathological examinations provided a more complete picture of the severe damage and developmental abnormalities caused by ZIKV infection than has been previously reported. The term congenital Zika syndrome is preferable to refer to these cases, as microcephaly is just one of the clinical signs of this congenital malformation disorder. Inst Pesquisa Prof Amorim Neto IPESQ, Campina Grande, Paraiba, Brazil Inst Saude Elpidio de Almeida, Campina Grande, Paraiba, Brazil Fac Ciencias Med Campina Grande, Campina Grande, Paraiba, Brazil Hosp Municipal Pedro I, Campina Grande, Paraiba, Brazil Univ Fed Rio de Janeiro, Inst Biol, Dept Genet, Rio De Janeiro, Brazil Univ Fed Campina Grande, Campina Grande, Paraiba, Brazil Tel Aviv Univ, Div Ultrasound Obstet & Gynecol, Lis Matern Hosp, Tel Aviv Sourasky Med Ctr,Sackler Fac Med, Tel Aviv, Israel Fundacao Med Fetal Latino Amer, Sao Paulo, Brazil Univ Fed Sao Paulo, Fundacao Inst Pesquisa & Ensino Diagnost Imagem, Sao Paulo, Brazil Univ Fed Rio de Janeiro, Inst Ciencias Biomed, Rio De Janeiro, Brazil Inst DOr Pesquisa & Ensino, Rio De Janeiro, Brazil Inst Estadual Cerebro Paulo Niemeyer, Lab Neuropatol, Rio De Janeiro, Brazil Fundacao Oswaldo Cruz, Inst Oswaldo Cruz, Lab Flavivirus, Rio De Janeiro, Brazil Univ Fed Sao Paulo, Dept Diagnost Imagem, Sao Paulo, Brazil Fundação Instituto de Pesquisa e Ensino de Diagnostico por Imagem, Universidade Federal de São Paulo, São Paulo, Brazil Departamento de Diagnóstico por Imagem, Universidade Federal de São Paulo, São Paulo, Brazil Web of Science

Early identification of patients co-infected with HIV and human T-lymphotropic virus type 1 (HTLV-1) is essential to improve care, as CD4+ T-cell counts have been revealed to be an unreliable laboratory parameter to monitor HIV infection in co-infection. Unfortunately, HTLV-1 testing is not currently available in sub-Saharan Africa. We conducted this study to determine the performance of absolute CD4+ T-cell count estimation in guiding the clinical suspicion of co-infection. A cross-sectional survey was conducted in antiretroviral-naïve HIV (AN-HIV) patients attending an HIV outpatient clinic in Maputo city, Mozambique. Seven hundred and one AN-HIV patients were enrolled in the study. The prevalence of HTLV-1 co-infection was 4.5% (95% confidence interval [CI] 3.0–6.0%). Logistic regression analysis showed that CD4+ T-cell count was an independent predictor of co-infection ( P value: 0.000). The performance of absolute CD4+ T-cell counts in predicting co-infection was higher in symptomatic HIV patients when compared with asymptomatic HIV patients. The best performance was achieved with the cut-off of CD4+ count of 500 cells/mm3, which gave sensitivity, specificity, positive and negative predictive values of 54.2%, 87.2%, 24.0% and 96.2%, respectively. In conclusion, our data provide evidence that the absolute CD4+ T-cell count is of moderate accuracy in guiding the clinical suspicion of co-infection in AN-HIV and its implementation could improve the care provided to a significant number of HIV patients in Mozambique.

The HIV/AIDS pandemic is primarily caused by HIV-1. Another virus type, HIV-2, is found mainly in West African countries. We hypothesized that population migration and mobility in Africa may have facilitated the introduction and spreading of HIV-2 in Mozambique. The presence of HIV-2 has important implications for diagnosis and choice of treatment of HIV infection. Hence, the aim of this study was to estimate the prevalence of HIV-2 infection and its genotype in Maputo, Mozambique. HIV-infected individuals (N = 1,200) were consecutively enrolled and screened for IgG antibodies against HIV-1 gp41 and HIV-2 gp36 using peptide-based enzyme immunoassays (pepEIA). Specimens showing reactivity on the HIV-2 pepEIA were further tested using the INNO-LIA immunoblot assay and HIV-2 PCR targeting RT and PR genes. Subtype analysis of HIV-2 was based on the protease gene. After screening with HIV-2 pepEIA 1,168 were non-reactive and 32 were reactive to HIV-2 gp36 peptide. Of this total, 30 specimens were simultaneously reactive to gp41 and gp36 pepEIA while two samples reacted solely to gp36 peptide. Only three specimens containing antibodies against gp36 and gp105 on the INNO-LIA immunoblot assay were found to be positive by PCR to HIV-2 subtype A. The proportion of HIV-2 in Maputo City was 0.25% (90%CI 0.01-0.49). The HIV epidemic in Southern Mozambique is driven by HIV-1, with HIV-2 also circulating at a marginal rate. Surveillance program need to improve HIV-2 diagnosis and consider periodical survey aiming to monitor HIV-2 prevalence in the country.

BACKGROUND: Screening for human T-lymphotropic virus-1/2 (HTLV-1/2) infection is not performed in blood banks in Mozambique. The aim was to determine the prevalence of HTLV-1/2 among blood donors of the Maputo Central Hospital Blood Bank and measure the coinfection rate of HTLV-1/2 with human immunodeficiency virus (HIV), hepatitis B virus (HBV), and syphilis. STUDY DESIGN AND METHODS: A total of 2019 consecutive blood donors were screened for HTLV-1/2 antibodies, HIV-1/2 antibodies, hepatitis B surface antigen (HBsAg), and rapid plasma reagin (RPR) for syphilis. Specimens reactive on a first HTLV-1/2 enzyme immunoassay (EIA) were retested using a second EIA. Specimens that were dually reactive on both EIAs were further tested using Western blot (WB) and real-time polymerase chain reaction (PCR). RESULTS: All 18 dually reactive specimens (0.89%; 95% confidence interval, 0.48%-1.30%) were positive for the presence of HTLV-1 by WB and real-time PCR. HTLV-2 was not detected. The prevalences of anti-HIV, HBsAg, and reactivity in the RPR test were 5.72, 6.01, and 0.98 percent, respectively. There was no significant association between HTLV-1 infection and demographic variables (age and sex) or serologic markers (HIV, HBsAg, and RPR). For the 17 HTLV-1–positive donors for whom serologic data for HIV, HBsAg, and syphilis RPR were available, 2 showed coinfection with HIV and 1 with HBV. CONCLUSION: Compared to other infectious agents, HTLV-1 is present at relatively low levels among blood donors in Mozambique. Cost and logistics will present as major challenges for introducing HTLV-1/2 screening in blood banks. In blood banks in Southern Africa where EIA testing is possible, a sequential algorithm of two EIAs may be a cost-efficient option for HTLV-1/2 screening.

Objectives: This assessment in Brazil was to evaluate the performance of commercially available HIV rapid test (RT) against the gold standard testing and to establish a highly sensitive and specific RT algorithm for HIV diagnosis. Design: A prospective, anonymous and unlinked study. Methods: An evaluation of seven commercially available RT to compare their performance against the gold standard tests for Brazil. This includes two competing enzyme immunoassays plus a Western blot for confirmation. After informed consent, whole blood samples were collected from volunteers in voluntary counselling and testing sites (n = 400), antenatal clinics (n = 500) and from HIV-positive controls in AIDS treatment centres (n = 200). Two seroconversion panels, one HIV-1 subtype (B, B′, C and F) panel and an operational assay performance evaluation were also part of the study parameters. Results: For the seven RT the clinical sensitivity ranged from 97.74 to 100% and clinical specificity from 99.43 to 100%. However, only four RT were considered acceptable after full evaluation. The two EIA had a clinical sensitivity of 100% and clinical specificity of 99.32 and 99.66%. Two RT had the same performance on the seroconversions panels as the EIA. The operational assay performance evaluation for the RT indicated that Hexagon and Capillus could not be classified as simple assays. Conclusion: We have provided evidence that RT assays can perform equally or better than EIA for the detection of HIV antibodies. The simplicity and rapidity of the RT warrants its utilization in an algorithm for a rapid diagnosis of HIV infection.

Mycobacterium avium complex (MAC) infection has not been reported as a major opportunistic infection among patients with AIDS in Latin American or Africa In this study 125 AIDS patients who had persistent fever anemia and leukopenia were examined among 2628 AIDS patients admitted to Instituto de Infectologia Emilio Ribas between May 1990 and April 1992. From the bone marrow aspirates of the 125 patients MAC was isolated from 23 (18.4%) and Mycobacterium tuberculosis was isolated from 9 (7.2%). Between 1985 and 1990 only 11 MAC isolations among 60000 cultures obtained from human immunodeficiency virus-seronegative patients were documented in Sao Paulo. Hence the minimal estimated rate of MAC infection in AIDS patients in this city was 23/2628 or 0.88%. These findings suggest that MAC infection is an important opportunistic infection especially among a subset of patients with AIDS in Brazil who have clinical characteristics and risk activities similar to those associated with MAC infections in North America and Europe. (authors)

CONTEXT: The hemoglobin (Hb) level is the most-used parameter for screening blood donors for the presence of anemia, one of the most-used methods for measuring Hb levels is based on photometric detection of cyanmetahemoglobin, as an alternative to this technology, HemoCue has developed a photometric method based on the determination of azide metahemoglobin. OBJECTIVE: To evaluate the performance of three methods for hemoglobin (Hb) determination in a blood bank setting. DESIGN: Prospective study utilizing blood samples to compare methods for Hb determination. SETTING: Hemotherapy Service of the Hospital Israelita Albert Einstein, a private institution in the tertiary health care system. SAMPLE: Serial blood samples were collected from 259 individuals during the period from March to June 1996. MAIN MEASUREMENTS: Test performances and their comparisons were assessed by the analysis of coefficients of variation (CV), linear regression and mean differences. RESULTS: The CV for the three methods were: Coulter 0.68%, Cobas 0.82% and HemoCue 0.69%. There was no difference between the mean Hb determination for the three methods (p>0.05). The Coulter and Cobas methods showed the best agreement and the HemoCue method gave a lower Hb determination when compared to both the Coulter and Cobas methods. However, pairs of methods involving the HemoCue seem to have narrower limits of agreement (± 0.78 and ± 1.02) than the Coulter and Cobas combination (± 1.13). CONCLUSION: The three methods provide good agreement for hemoglobin determination. CONTEXTO: A medida de hemoglobina (Hb) é o indicador mais utilizado para a verificação de anemia, na triagem de doadores de sangue. Atualmente o método fotométrico mais utilizado é o da ciano-metahemoglobina. Como alternativa a essa tecnologia, a Hemocue desenvolveu um método fotométrico baseado na determinação da azida metahemoglobina. OBJETIVO: Avaliar o desempenho de três métodos de dosagem de hemoglobina (Hb) em doadores de sangue. TIPO DE ESTUDO: Estudo prospectivo utilizando amostras de sangue para comparar testes de dosagem de Hb. LOCAL: Serviço de Hemoterapia do Hospital Israelita Albert Einstein, instituição privada de atenção terciária de saúde. AMOSTRA: Foram colhidas amostras seriadas de sangue de 259 indivíduos no período de março a junho de 1996. VARIÁVEIS ESTUDADAS: O desempenho dos testes e suas comparações foram realizados pela análise do coeficiente de correlação, regressão linear e comparação das médias. RESULTADOS: Os coeficientes de variação para os três métodos foram: Coulter, 0.68%, Cobas, 0.82%, e HemoCue, 0.69%. Não houve diferenças estatísticamente significativas entre as médias das determinações de hemoglobina pelos três métodos (p>0,05). Os métodos Coulter e Cobas mostraram melhor concordância enquanto o método HemoCue teve medidas de hemoglobina menores. Entretanto, os pares Coulter/HemoCue e Cobas/HemoCue tiveram limites de concordância mais estreitos (+ 0,78 e + 1,02) daquele obtido com o par Coulter/Cobas (+ 1,13). CONCLUSÕES: Os três métodos demostraram excelente concordância para a dosagem de hemoglobina.

Classical serological screening assays for Chagas' disease are time consuming and subjective. The objective of the present work is to evaluate the enzyme immuno-assay (ELISA) methodology and to propose an algorithm for blood banks to be applied to Chagas' disease. Seven thousand, nine hundred and ninety nine blood donor samples were screened by both reverse passive hemagglutination (RPHA) and indirect immunofluorescence assay (IFA). Samples reactive on RPHA and/or IFA were submitted to supplementary RPHA, IFA and complement fixation (CFA) tests. This strategy allowed us to create a panel of 60 samples to evaluate the ELISA methodology from 3 different manufacturers. The sensitivity of the screening by IFA and the 3 different ELISA's was 100%. The specificity was better on ELISA methodology. For Chagas disease, ELISA seems to be the best test for blood donor screening, because it showed high sensitivity and specificity, it is not subjective and can be automated. Therefore, it was possible to propose an algorithm to screen samples and confirm donor results at the blood bank.Os testes sorológicos clássicos utilizados na triagem de doadores de sangue são trabalhosos e subjetivos. O objetivo do presente trabalho é o de avaliar a metodologia imuno-enzimática (ELISA) e propor um algorítmo para doença de Chagas em bancos de sangue. Foram estudados 7999 doadores de sangue e/ou componentes cujas amostras foram testadas com o objetivo de tria-las sorologicamente para doença de Chagas utilizando hemaglutinação passiva reversa (RPHA) e imunofluorescência indireta (IFA). As amostras reativas em pelo menos uma destas metodologias, foram retestadas com reativos diferentes por RPHA, IFA e fixação de complemento (CFA). Esta estratégia nos permitiu criar um painel de 60 amostras com as quais tornou-se possível a avaliação do método imunoenzimático (ELISA). A sensibilidade da triagem dos doadores pelos métodos ELISA e IFA foi de 100%. A especificidade foi melhor para a metodologia imunoenzimática. O teste ELISA parece ser o ideal para triagem em bancos de sangue pois é altamente sensível, específico, não é subjetivo e pode ser automatizado. Desta forma, torna-se possível a formulação de um algorítimo a ser utilizado na triagem sorológica e confirmação de resultados em doadores de bancos de sangue.

Prison populations are at increased risk of both human immunodeficiency virus (HIV) and Mycobacterium tuberculosis infections, but among female inmates information on such risks remains scarce, especially in developing countries. Between October 1992 and November 1993, 350 women incarcerated at a prison in Sao Paulo, Brazil, were prospectively evaluated for HIV and M. tuberculosis infection and disease. Among them, 87 (25%) were HIV seropositive, and 20 (5.7%) had tuberculosis (TB). During the incarceration period, the purified protein derivative test conversion rate was 29% for HIV-positive and 32% for HIV-negative women. However, the incidence of TB was 9.9 per 100 person-years for HIV-positive and 0.7 per 100 person-years of incarceration for HIV-negative women (p < 0.0001). A multivariate analysis indicated that HIV infection (p < 0.0001) and incarceration time < 12 months (p < 0.05) were each associated with TB. These findings indicate that new transmissions of M. tuberculosis infection are common among female inmates and that HIV-infected women are more likely to acquire active disease during the first 12 months of incarceration. Because of their role in childbearing and care female inmates are an important potential source of transmission of M. tuberculosis, and new strategies to control the spread of TB in prisons need to be developed.

Introduction: Metrological traceability is a little-known and little-discussed metrology theme in clinical laboratories, although it is the basis for comparable results. It is associated with certified reference material (CRM) and reference method (RMet). When it is used in the supply chain by diagnostic kit manufacturers, it ensures accuracy of the results yielded by laboratories. Objective: This study shows the availability of information on metrological traceability provided by diagnostic kit manufacturers. Method: It was done with the information obtained in kits of glucose, urea, creatinine, uric acid and cholesterol participants in a proficiency testing program throughout 2012 and 2013. Results and conclusion: In the research, 18 producers of reference materials (RMs) and 204 measurands available for laboratory medicine were found. In the study of metrological traceability, the preferential use of CRM was demonstrated by kit manufacturers (glucose 60%, urea 69%, creatinine 60%, uric acid 50%, and cholesterol 43%). An important factor is that there are a significant number of kits that do not report traceability (glucose 16%, urea 19%, creatinine 16%, uric acid 13%, and cholesterol 5%), although it is a requirement for product registration in Brazil. We hope that this study will contribute to sensitize the laboratory community to the need for a more comprehensive knowledge of this subject, and that it will stimulate institutions involved in the dissemination of knowledge in laboratory medicine to hold discussions on this topic. RESUMO Introdução: Rastreabilidade metrológica é um tema da metrologia pouco conhecido e discutido nos laboratórios clínicos, apesar de ser a base para resultados comparáveis; associa-se a material de referência certificado (MRC) e a método de referência (MetR). Quando usada na cadeia de suprimentos pelos fabricantes de conjuntos diagnósticos, atua na garantia da exatidão dos resultados produzidos pelos laboratórios. Objetivo: Apresentar a disponibilidade das informações sobre rastreabilidade metrológica fornecidas pelos fabricantes de conjuntos diagnósticos. Método: O estudo foi feito com as informações obtidas nos conjuntos diagnóstico de glicose (GLI), ureia (URE), creatinina (CRE), ácido úrico (AU) e colesterol (COL) participantes de um programa de ensaio de proficiência ao longo de 2012 e 2013. Resultados e conclusão: Na pesquisa sobre produtores de materiais de referência (MRs) e de produtos disponibilizados, foram encontrados 18 produtores e 204 analitos para a área de laboratórios clínicos. No estudo sobre rastreabilidade metrológica, foi demonstrado o uso preferencial de MRC pelos fabricantes de conjuntos diagnósticos (GLI 60%; URE 69%; CRE 60%, AU 50% e COL 43%), bem como o dado importante de que há um número expressivo de conjuntos diagnósticos que não informa rastreabilidade (GLI 16%; URE 19%; CRE 16%, AU 13% e COL 5%), embora ela seja requisito em norma nacional que regulamenta o registro de produtos. Esperamos que este estudo contribua para sensibilizar a comunidade laboratorial da necessidade de conhecimento mais abrangente acerca deste assunto e que estimule as instituições relacionadas com a disseminação de conhecimento na área de laboratório clínico a promover discussões sobre o tema.

BACKGROUND: Little is known about the prevalence of and risk factors for human T-lymphotropic virus type I and type II (HTLV-I, HTLV-II) infections in Brazil. STUDY DESIGN AND METHODS: Sera from 17,063 healthy Brazilian donors were screened by enzyme-linked immunosorbent assay for antibody to HTLV-I/II between August 1991 and July 1993. Repeatedly reactive samples were confirmed by Western blot, and discrimination between HTLV-I and HTLV-II was made by polymerase chain reaction or synthetic peptide enzyme-linked immunosorbent assay. A univariate analysis was performed on demographic and serologic data. RESULTS: HTLV-I infection was demonstrated in 83 percent of the 30 donors with reactive serologic tests (0.15% of the total tested [17,063]; 95% CI, 0.09-0.20) and HTLV-II infection in 17 percent (0.03% of the total tested [17,063]; 95% CI, 0.01-0.05). HTLV-I-positive donors were more likely than reference groups to be of Asian ethnicity (odds ratio [OR] 15.1; reference group: whites), more than 50 years old (OR 4.2; reference group: 20–29 years old), and positive for antibody to hepatitis C virus (anti-HCV) (OR 21.8) or to hepatitis B core (antigen) (anti-HBc) (OR 5.7). HTLV-II showed a significant association with anti-HCV (OR 75.2) and anti-HBc (OR 21.8). Eleven of the 25 HTLV-I- positive donors were counseled. Family origin in endemic areas of Japan (n = 4), prior blood transfusion (n = 3), or sexual contact with prostitutes (n = 1) were the risk factors reported by 8 donors. In 3 white men, no risk factors could be identified. CONCLUSION: Both HTLV-I and HTLV-II occur among Brazilian blood donors. HTLV-I is associated with Asian ethnicity, greater age, and the presence of anti-HCV and anti-HBc. Three HTLV-I-positive donors had a history of blood transfusion, which emphasizes the need for HTLV-I/II screening in Brazil.