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

10.3823/2532 ◽  
2017 ◽  
Vol 10 ◽  
Author(s):  
Orlando Da Costa Ferreira Jr. ◽  
Nazle Mendonca Collaco Veras ◽  
Ana Flávia Nassif Coelho Pires ◽  
Maria Luiza Bazzo ◽  
Leonardo Rapone Da Motta ◽  
...  
Keyword(s):  
Western Blot ◽  
Whole Blood ◽  
Oral Fluid ◽  
Point Of Care ◽  
Hiv Positive ◽  
Hiv Diagnosis ◽  
Evaluation Program ◽  
Test Batch ◽  
Hiv 1 ◽  
Selection Of

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.

scholarly journals The performance of hepatitis C virus ( HCV ) antibody point‐of‐care tests on oral fluid or whole blood and dried blood spot testing for HCV serology and viral load among individuals at higher risk for HCV in South Africa

2021 ◽  
Vol 4 (1) ◽  
Author(s):  
Nishi Prabdial‐Sing ◽  
Lucinda Gaelejwe ◽  
Lillian Makhathini ◽  
Jayendrie Thaver ◽  
Morubula Jack Manamela ◽  
...  
Keyword(s):  
South Africa ◽  
Hepatitis C Virus ◽  
Viral Load ◽  
Hepatitis C ◽  
Whole Blood ◽  
Oral Fluid ◽  
Point Of Care ◽  
Hcv Antibody ◽  
Point Of Care Tests ◽  
Blood Spot

scholarly journals Feasibility and acceptability of implementing early infant diagnosis of HIV in Papua New Guinea at the point of care: a qualitative exploration of health worker and key informant perspectives

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e043679
Author(s):  
Yasmin Mohamed ◽  
Martha Kupul ◽  
Janet Gare ◽  
Steven G Badman ◽  
Selina Silim ◽  
...  
Keyword(s):  
Papua New Guinea ◽  
Standard Care ◽  
Health Workers ◽  
Point Of Care ◽  
Hiv Positive ◽  
Early Infant Diagnosis ◽  
Pmtct Programme ◽  
Early Infant ◽  
Qualitative Exploration ◽  
Hiv 1

IntroductionEarly infant diagnosis (EID) of HIV and timely initiation of antiretroviral therapy can significantly reduce morbidity and mortality among HIV-positive infants. Access to EID is limited in many low-income and middle-income settings, particularly those in which standard care involves dried blood spots (DBS) sent to centralised laboratories, such as in Papua New Guinea (PNG). We conducted a qualitative exploration of the feasibility and acceptability of implementing a point-of-care (POC) EID test (Xpert HIV-1 Qualitative assay) among health workers and key stakeholders working within the prevention of mother-to-child transmission of HIV (PMTCT) programme in PNG.MethodsThis qualitative substudy was conducted as part of a pragmatic trial to investigate the effectiveness of the Xpert HIV-1 Qualitative test for EID in PNG and Myanmar. Semistructured interviews were undertaken with 5 health workers and 13 key informants to explore current services, experiences of EID testing, perspectives on the Xpert test and the feasibility of integrating and scaling up POC EID in PNG. Coding was undertaken using inductive and deductive approaches, drawing on existing acceptability and feasibility frameworks.ResultsHealth workers and key informants (N=18) felt EID at POC was feasible to implement and beneficial to HIV-exposed infants and their families, staff and the PMTCT programme more broadly. All study participants highlighted starting HIV-positive infants on treatment immediately as the main advantage of POC EID compared with standard care DBS testing. Health workers identified insufficient resources to follow up infants and caregivers and space constraints in hospitals as barriers to implementation. Participants emphasised the importance of adequate human resources, ongoing training and support, appropriate coordination and a sustainable supply of consumables to ensure effective scale-up of the test throughout PNG.ConclusionsImplementation of POC EID in a low HIV prevalence setting such as PNG is likely to be both feasible and beneficial with careful planning and adequate resources.Trial registration number12616000734460.

scholarly journals Performance evaluation of the point-of-care SAMBA I and II HIV-1 Qual whole blood tests

2016 ◽  
Vol 237 ◽  
pp. 143-149 ◽  
Author(s):  
Allyson V. Ritchie ◽  
Neha Goel ◽  
Hiroshi Sembongi ◽  
Jesse Lehga ◽  
Laura E. Farleigh ◽  
...  
Keyword(s):  
Performance Evaluation ◽  
Whole Blood ◽  
Point Of Care ◽  
Blood Tests ◽  
Hiv 1

scholarly journals Laboratory-based Evaluation of Wondfo HIV1/2 Rapid Test Kits in the Gambia, December 2020

2021 ◽  
Vol 8 (6) ◽  
Author(s):  
Mendy A ◽  
◽  
Sanneh ML ◽  
Jarju ML ◽  
Ceesay FB ◽  
...  
Keyword(s):  
Hiv Testing ◽  
Whole Blood ◽  
Rapid Test ◽  
The Gambia ◽  
Hiv Positive ◽  
Hiv Screening ◽  
Predictive Values ◽  
First Response ◽  
Sensitivity Specificity ◽  
Hiv 1

Background: HIV rapid diagnosis in The Gambia is mainly done using Determine HIV-1/2 and First Response HIV 1.2.0 or SD Bioline HIV-1/2 3.0 for screening and sero-typing of HIV respectively among children and adults. Polymerase Chain Reaction (PCR) is used for the detection of the HIV viral genome among infants born to HIV positive mothers. This is the HIV testing Algorithm recommended in the HIV testing guidelines of The Gambia for both HIV Counseling and Testing (HCT), Prevention of Mother-to-Child Transmission of HIV (PMTCT) as well as other clinical requests for HIV testing. At the National Public Health Reference Laboratories (NPHRL), ELISA is the first line of testing for HIV while First Response HIV 1.2.0 or SD Bioline HIV 1/2 3.0 is used for preliminary serotyping. MP Diagnostics HIV Blot 2.2 Western Assay, which is the gold standard for HIV testing in The Gambia, is used as the tie breaker (i.e., when there are discordant results). The aim of this study was to evaluate the sensitivity and specificity of the Wondfo HIV 1/2 rapid test kit for the detection of human antibodies to HIV in serum/plasma/whole blood and dried blood spots. Methods: The sensitivity, specificity, positive and negative predictive values of Wondfo HIV 1/2 kits were evaluated in terms of HIV screening against Determine HIV1/2, GenScreen Ultra HIV Ag-Ab ELISA and First Response HIV 1.2.0 using a total of 401 samples. Of these, 351 were sera/plasma samples {100 HIV negative, 250 HIV positive and 1 indeterminate that were stored at -20°C, 26 were whole blood samples (4 negative, 22 positive), and 24 were dried blood spot (DBS) specimens (16 negative and 8 positive) were used for this evaluation. HIV positive specimens were previously sero-typed using First Response HIV-1.2.0 test cards and MP Diagnostics HIV Blot 2.2 Western Assay. Results: The evaluation shows that the sensitivity, specificity, positive and negative predictive values of Wondfo HIV 1/2 Test Kits with regards to HIV Screening when compared with the GenScreen Ultra HIV Ag-Ab ELISA and First Response 1.2.O (n=401) were 100%, 100%, 100%, and 100% respectively. Similarly, the sensitivity, specificity, positive and negative predictive values of Wondfo HIV 1/2 Test Kits with regards to HIV Screening compared to Determine HIV1/2 (n=401) were 99.64%, 100%, 100%, and 99.17% respectively. Conclusions: This study demonstrates that Wondfo HIV 1/2 test kits have a high sensitivity and specificity when used for the detection of HIV antibodies using human serum/plasma, whole blood or DBS.

scholarly journals Finger-Stick Whole Blood HIV-1/-2 Home-Use Tests Are More Sensitive than Oral Fluid-Based In-Home HIV Tests

PLoS ONE ◽  
2014 ◽  
Vol 9 (6) ◽  
pp. e101148 ◽  
Author(s):  
Marie Jaspard ◽  
Gwenaël Le Moal ◽  
Mariam Saberan-Roncato ◽  
David Plainchamp ◽  
Aurélie Langlois ◽  
...  
Keyword(s):  
Whole Blood ◽  
Oral Fluid ◽  
Finger Stick ◽  
Hiv 1

scholarly journals Study to evaluate the performance of a point-of-care whole blood HIV viral load test (SAMBA II HIV-1 Semi-Q Whole Blood).

2020 ◽  
Author(s):  
Gary Brook ◽  
Tetiana Stepchenkova ◽  
Innocent M. Ali ◽  
Sandra Chipuka ◽  
Neha Goel ◽  
...  
Keyword(s):  
Viral Load ◽  
Whole Blood ◽  
Point Of Care ◽  
Venous Blood ◽  
Load Test ◽  
Hiv Viral Load ◽  
Percent Agreement ◽  
Finger Prick ◽  
Hiv 1 ◽  
Point Of Care Assay

Remote areas of many low and middle income (LMI) countries have poor access to HIV viral load (HIV VL) testing. The SAMBA-II (Simple Amplification-based Assay) Semi-Q Whole Blood Test (Diagnostics for the Real World (DRW), Cambridge, UK) is a point of care assay which uses leucodepletion technology to allow whole blood testing in remote settings. 1540 consecutive HIV-positive clinic patients in Cameroon (250), UK (633), Ukraine (412) and Zimbabwe (245) donated venous blood (all countries) and finger-prick blood (all except UK) for testing on SAMBA-II. SAMBA II results were compared with simultaneous plasma results on the Abbott RealTime HIV-1 (Abbott Molecular, Des Plaines, IL) viral load assay and interpreted as either <1000 RNA copies/ml or ≥1000 RNA copies/ml. For 1528 venous whole-blood samples tested on SAMBA II, overall percent agreement with the reference test at a cut-off of HIV VL ≥1000 cps/ml was 96.9% (1480/1528 95% CI 95.9-97.7), negative percent agreement 97.7% (1259/1289 95% CI 96.7-98.4), positive percent agreement 92.5% (221/239 95% CI 88.4-95.5). For 854 finger-prick samples there was 95.0% (811/854 95% CI 93.3-96.3) overall percent agreement; negative percent agreement 98.0% (625/638, 95% CI 96.5-98.9); positive percent agreement 86.1% (186/216 95% CI 80.8-90.4). These rose to 93.5% (82.1, 98.6), 97.6% (95.6, 98.8) and 95.6% (93.3, 97.3) after exclusion of aberrant results from the Ukraine centre. These results show a high level of agreement between SAMBA-II and a laboratory-based assay. SAMBA-II has a performance that is suitable to use as a VL point of care assay in remote settings

WITHDRAWN: Rapid, point-of-care extraction of HIV-1 proviral DNA from whole blood for detection by real-time PCR

2009 ◽  
Author(s):  
S. R. Jangam ◽  
D. H. Yamada ◽  
S. M. McFall ◽  
D. M. Kelso
Keyword(s):  
Real Time ◽  
Real Time Pcr ◽  
Whole Blood ◽  
Point Of Care ◽  
Proviral Dna ◽  
Hiv 1

scholarly journals Use of Oral Fluid in a Rapid Syphilis Test Assay

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S107-S108 ◽  
Author(s):  
Chelsea Shannon ◽  
Claire Bristow ◽  
Sasha Herbst De Cortina ◽  
Jennifer Chang ◽  
Jeffrey Klausner
Keyword(s):  
Whole Blood ◽  
Oral Fluid ◽  
Point Of Care ◽  
Fluid Collection ◽  
Treponema Pallidum ◽  
Rapid Test ◽  
High Sensitivity ◽  
The United States ◽  
Collection Device ◽  
Positive Results

Abstract Background From 2014 to 2015, the syphilis rate in the United States increased by 19%, reaching its highest rate since 1994. Currently, point-of-care syphilis assays use fingerstick or venipuncture whole blood to identify Treponema pallidum (TP) antibodies by qualitative immunoassay. However, patients and providers prefer oral fluid testing to whole blood testing. In this study, we aimed to determine whether a rapid syphilis test intended for use on whole blood could be used to detect TP antibodies in oral fluid. Methods Oral fluid was collected from 72 participants using the Super•SAL™ Oral Fluid Collection Device (Oasis Diagnostics®, Vancouver, WA). The device uses an absorbent cylindrical pad to collect and filter ~1 mlml of oral fluid. Oral fluid filtrate was tested using the SD Bioline Syphilis 3.0 rapid test (Alere Diagnostics, MA) following manufacturer directions for whole blood. TP particle agglutination (TPPA) and rapid plasma reagin (RPR) results derived from participants’ medical records were used as reference values. We used three different definitions as comparators: 1: TPPA reactive; 2: TPPA and RPR reactive and 3: TPPA reactive and RPR titer &gt;1:4. Those with non-reactive TPPA and RPR results were considered seronegative. We calculated the sensitivity and specificity for definition 1 and sensitivity for definitions 2 and 3. We used the exact binomial method to determine 95% confidence intervals (CI). Results With definitions 1, 2, and 3, respectively, sensitivity was 83.3% (CI: 67.2, 93.6), 86.4% (CI: 65.1, 97.1), and 100% (CI: 71.5, 100). Specificity was 47.2% (CI: 36.5, 75.5). Conclusion The high sensitivity of the SD Bioline Syphilis 3.0 test using oral fluid suggests a strong potential for the development of accurate rapid oral syphilis tests. Sensitivity increased with higher RPR titer. False positive results may be due to the presence of non-venereal treponemal antibodies in oral fluid. Further research and development are needed to optimize specificity. Disclosures All authors: No reported disclosures.

Barriers to HIV testing among Australian gay men

Sexual Health ◽  
2012 ◽  
Vol 9 (5) ◽  
pp. 453 ◽  
Author(s):  
Garrett Prestage ◽  
Graham Brown ◽  
Phillip Keen
Keyword(s):  
Hiv Testing ◽  
Gay Men ◽  
Online Survey ◽  
Point Of Care ◽  
Anal Intercourse ◽  
Hiv Positive ◽  
Hiv Diagnosis ◽  
Increased Risk ◽  
To Receive ◽  
Hiv Positive Men

Objective To investigate the barriers to HIV testing among Australian gay men. Methods: An online survey was conducted to explore reasons for avoiding and delaying testing for HIV; 519 non-HIV-positive men completed the online survey. Results: Most non-HIV-positive men (92.9%) had been tested for HIV, with 75.4% indicating they had been tested in the previous year. The most common reasons for avoiding or delaying testing were a belief that they had not done anything risky (41.2%) and the need to return for a second clinic visit to receive results (40.3%). Among men who engaged in unprotected anal intercourse with casual partners (UAIC), those who had not been recently tested were more likely to cite the lack of any symptoms as reasons for not having tested (adjusted odds ratio: 2.34; 95% confidence interval: 1.03–5.31; P = 0.041). Conclusions: For men who do not engage in risky sex, the decision not to test is probably reasonable, but those who engage in noncondom-based risk reduction may be at some increased risk and should be encouraged to test relatively often. Changes to Australia’s national HIV testing policy may ameliorate some of the need to return for second clinic visits to receive results, but the policy still requires full implementation, including the introduction of rapid point-of-care HIV testing to Australia. Among men who engage in UAIC, there appears to be a particular need for information about the benefits of early treatment after HIV diagnosis and about the relative likelihood of experiencing HIV seroconversion illness.

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