Evaluation of Performance and Acceptability of Two Rapid Oral Fluid Tests for HIV Detection in Mozambique

Baltazar, Cynthia Semá; Raposo, Cristina; Jani, Ilesh; Shodell, Daniel; Correia, Della; Silva, Cristiane Gonçalves da; Kalou, Mireille; Patel, Hetal; Parekh, Bharat

doi:10.1128/jcm.01098-14

Cited by 24 publications

(23 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Studies concerning OraQuick ADVANCE ® Rapid HIV-1/2 Antibody Test performance for oral fluid samples [10][11][12][13][14][15] described a sensitivity range from 99.1% [11] to 100% [13], and a specificity from 99.6% [11] to 100% [13]. The present report is in agreement with the findings presented by these authors.…”

Section: Discussionsupporting

confidence: 83%

Brazilian Program For HIV Point-Of-Care Test Evaluation: A Decade’s Experience

et al. 2017

View full text Add to dashboard Cite

Background: 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™ IntroductionFor most infectious diseases, prompt and accurate diagnosis is a crucial public health strategy for implementing early and more effective treatment and, consequently, interrupting transmission chains sustained by untreated unaware cases [1].According to the 2015 Brazilian HIV/AIDS Epidemiological Bulletin, since 1980, a total of 798,366 Acquired Immunodeficiency Syndrome (AIDS) cases and 290,929 AIDS related deaths have been registered in the country. Over the last decade, AIDS detection rates have shown that HIV/AIDS epidemic in Brazil has been relatively stable (with an AIDS incidence rate of 20.5 per 100,000 inhabitants), although there were important differences among Brazilian states, ranging from 9.2 AIDS cases per 100,000 inhabitants (Acre state) to 39.2 AIDS cases per 100,000 inhabitants (Amazonas state) [2].In Brazil, HIV diagnostic is regulated by the Ministerial Directive MS/SVS n° 29 [3], which approved the Technical Manual for the Diagnosis of HIV Infection in Adults and Children. The Manual establishes six algorithms for HIV diagnosis, two of which are based on the use of point-of-care tests (POCTs). The main reasons for employing POCTs in Brazil are to expand and to allow HIV diagnosis outside health units including remote areas, such as the Amazon region. Indeed, HIV POCTs have been widely used to test parturient and puerperal women unaware of their serological status, patients attending emergency clinics, campaigns...

show abstract

Section: Discussionsupporting

confidence: 83%

Brazilian Program For HIV Point-Of-Care Test Evaluation: A Decade’s Experience

et al. 2017

View full text Add to dashboard Cite

show abstract

“…Results from field evaluations in Nigeria and Mozambique indicate that the assay performs well in OF and whole blood [4,8] specimens from these countries which predominantly have subtypes A, C, CRF-02 AG, and G. Cameroon specimens of these subtypes were also detected using plasma in our study. However, a recent study showed a lower sensitivity in OF among specimens with low viral load and/or high CD4 counts [5].…”

Section: Discussionmentioning

confidence: 80%

“…DPP ® HIV is the first RT approved in the U.S. that incorporates the dual path platform (DPP) technology. Although the DPP ® HIV received the Clinical Laboratory Improvement Amendments (CLIA) waiver in 2014, this test had been used, mainly with oral fluid (OF), outside of the U.S. since 2009 [4,5]. In addition, in 2013, a RT that detects and distinguishes between HIV antigen and antibody was approved in the US.…”

Section: Introductionmentioning

confidence: 98%

“…Although the DPP ® HIV can be used with different specimen types and studies have reported very good sensitivity and specificity for DPP ® HIV using OF and whole blood [4,5,[7][8][9], no study has been conducted in early infections and/or using plasma specimens. Results using plasma specimens have been limited to the manufacturer's clinical trials which reports 99.9% sensitivity for HIV-1 and 99.5% for HIV-1 non-B subtypes, 100% sensitivity for HIV-2, and 99.9% specificity [6].…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Performance evaluation of the CHEMBIO DPP® (dual path platform) HIV-1/2 assay in early and established infections

Masciotra

Price

Sprinkle

et al. 2015

Journal of Clinical Virology

View full text Add to dashboard Cite

“…The major advantages of replacing serum/plasma with OF include easy access to testing and noninvasive collection while maintaining high-level performance (5,6,7). OF tests do not require the presence of experienced healthcare personnel.…”

Section: Introductionmentioning

confidence: 99%

Validation study of a conventional enzyme immunoassay to detect HIV antibodies in oral fluid

Staneková¹,

Mirandola²,

Gios³

et al. 2016

BLL

View full text Add to dashboard Cite

OBJECTIVES: The aim of our study was to validate the Genscreen HIV ½ version 2 (BIO-RAD) for detecting HIV antibodies in oral fl uid specimens (OF). BACKGROUND: The advantage of assays to detect HIV infection in OF lies in the on-site easy access and noninvasive sample collection. METHODS: Paired serum and OF were collected from 496 subjects (263 HIV-positive and 233 HIV-negative) using the Oracol test kit (Oracle Diagnostics, Inc). The quality of OF was verifi ed by measuring total IgGs using the Human IgG ELISA Quantitation Kit (Bethyl Lab.inc). All reactive OF samples were retested by Western blot HIV1/2 BLOT 2.2 (MP Biomedical, Singapore, China). RESULTS: Of 263 OF samples from participants with blood-based HIV-positive results, 259 were positive by Genscreen HIV ½ version 2 (98.48% sensitivity, 95% CI; 96.2-99.6). The 233 individuals who had a non-reactive HIV blood test were found negative on testing their OF by Genscreen HIV ½ version 2 (100% specifi city, 95% CI; 98.4-100). NPV and PPV of the assay were 98.31% (95% CI; 95.74-99.34) and 100%, (95% CI; 98.53-100.00), respectively. CONCLUSION: Genscreen HIV ½ version 2 (Bio-Rad) is a prospective method for HIV surveillance studies in hard-to-reach populations with high risk behavior using non

show abstract

Evaluation of Performance and Acceptability of Two Rapid Oral Fluid Tests for HIV Detection in Mozambique

Cited by 24 publications

References 12 publications

Brazilian Program For HIV Point-Of-Care Test Evaluation: A Decade’s Experience

Brazilian Program For HIV Point-Of-Care Test Evaluation: A Decade’s Experience

Performance evaluation of the CHEMBIO DPP® (dual path platform) HIV-1/2 assay in early and established infections

Validation study of a conventional enzyme immunoassay to detect HIV antibodies in oral fluid

Contact Info

Product

Resources

About