scholarly journals Evaluation of nine HIV rapid test kits to develop a national HIV testing algorithm in Nigeria

Author(s):  
Orji Bassey ◽  
Kyle Bond ◽  
Adebayo Adedeji ◽  
Odafen Oke ◽  
Ado Abubakar ◽  
...  

Background: Non-cold chain-dependent HIV rapid testing has been adopted in many resource-constrained nations as a strategy for reaching out to populations. HIV rapid test kits (RTKs) have the advantage of ease of use, low operational cost and short turnaround times. Before 2005, different RTKs had been used in Nigeria without formal evaluation. Between 2005 and 2007, a study was conducted to formally evaluate a number of RTKs and construct HIV testing algorithms. Objectives: The objectives of this study were to assess and select HIV RTKs and develop national testing algorithms. Method: Nine RTKs were evaluated using 528 well-characterised plasma samples. These comprised 198 HIV-positive specimens (37.5%) and 330 HIV-negative specimens (62.5%), collected nationally. Sensitivity and specificity were calculated with 95% confidence intervals for all nine RTKs singly and for serial and parallel combinations of six RTKs; and relative costs were estimated. Results: Six of the nine RTKs met the selection criteria, including minimum sensitivity and specificity (both ≥ 99.0%) requirements. There were no significant differences in sensitivities or specificities of RTKs in the serial and parallel algorithms, but the cost of RTKs in parallel algorithms was twice that in serial algorithms. Consequently, three serial algorithms, comprising four test kits (BundiTM, DetermineTM, Stat-Pak® and Uni-GoldTM) with 100.0% sensitivity and 99.1% – 100.0% specificity, were recommended and adopted as national interim testing algorithms in 2007. Conclusion: This evaluation provides the first evidence for reliable combinations of RTKs for HIV testing in Nigeria. However, these RTKs need further evaluation in the field (Phase II) to re-validate their performance.

Author(s):  
Tivani P. Mashamba-Thompson ◽  
Pravi Moodley ◽  
Benn Sartorius ◽  
Paul K. Drain

Introduction: South African guidelines recommend two rapid tests for diagnosing human immunodeficiency virus (HIV) using the serial HIV testing algorithm, but the accuracy and compliance to this algorithm is unknown in rural clinics. We evaluated the accuracy of HIV rapid testing and the time to receiving test results among pregnant women in rural KwaZulu-Natal (KZN).Method: We observed the accuracy of rapid HIV testing algorithms for 208 consenting antenatal patients accessing voluntary HIV testing services in nine rural primary healthcare (PHC) clinics in KZN. A PHC-based HIV counsellor obtained finger-prick whole blood from each participant to perform rapid testing using the Advanced Quality™ One Step anti-HIV (1&2) and/or ABON™ HIV 1/2/O Tri-Line HIV test. A research nurse obtained venous blood for an enzyme-linked immunosorbent assay (ELISA) HIV test, which is the gold standard diagnostic test. We recorded the time of receipt of HIV test results for each test.Results: Among 208 pregnant women with a mean age of 26 years, 72 women from nine rural PHC clinics were identified as HIV-positive by two rapid tests with an HIV-prevalence of 35% (95% Bayesian credibility intervals [BCI]: 28% – 41%). Of the 208 patients, 135 patients from six clinics were tested with the serial HIV testing algorithm. The estimated sensitivity and specificity for the 135 participants were 100% (95% confidence interval [CI]: 93% – 100%) and 99% (CI: 95% – 100%), respectively. The positive predictive value and negative predictive value were estimated at 98% (CI: 94% – 100%) and 95% (CI: 88% – 99%), respectively. All women received their HIV rapid test results within 20 min of testing. Test stock-out resulted in poor test availability at point-of-care, preventing performance of a second HIV test in three out of nine PHC clinics in rural KZN.Conclusion: Despite the poor compliance with national guidelines for HIV rapid testing services, HIV rapid test results provided to pregnant women in rural PHC clinics in KZN were generally accurate and timely. Test stock-out was shown to be one of the barriers to test availability in rural PHC clinics, resulting in poor compliance with guidelines. We recommend a compulsory confirmation HIV rapid test for all HIV-negative test results obtained from pregnant patients in rural and resource-limited settings.


2020 ◽  
Vol 45 (6) ◽  
pp. 1228-1235
Author(s):  
Shamaya Whitby ◽  
◽  
Amanda Smith ◽  
Rebecca Rossetti ◽  
Johanna Chapin-Bardales ◽  
...  

Abstract HIV rapid testing algorithms (RTAs) using any two orthogonal rapid tests (RTs) allow for on-site confirmation of infection. RTs vary in performance characteristics therefore the selection of RTs in an algorithm may affect identification of infection, particularly if acute. National HIV Behavioral Surveillance (NHBS) assessed RTAs among men who have sex with men recruited using anonymous venue-based sampling. Different algorithms were evaluated among participants who self-reported never having received a positive HIV test result prior to the interview. NHBS project areas performed sequential or parallel RTs using whole blood. Participants with at least one reactive RT were offered anonymous linkage to care and provided a dried blood spot (DBS) for testing at CDC. Discordant results (RT-1 reactive/RT-2 non-reactive) were tested at CDC with lab protocols modified for DBS. DBS were also tested for HIV-1 RNA (VL) and antiretroviral (ARV) drug levels. Of 6500 RTAs, 238 were RT-1 reactive; of those, 97.1% (231/238) had concordant results (RT-1/RT-2 reactive) and 2.9% (7/238) had discordant results. Five DBS associated with discordant results were available for confirmation at CDC. Four had non-reactive confirmatory test results that implied RT-1 false reactivity; one had ambiguous confirmatory test results which was non-reactive in further testing. Regardless of order and type of RT used, RTAs demonstrated high concordant results in the population surveyed. Additional laboratory testing on DBS following discordant results confirmed no infection. Implementing RTAs in the context of anonymous venue-based HIV testing could be an option when laboratory follow-up is not practicable.


2015 ◽  
Vol 22 (7) ◽  
pp. 817-822 ◽  
Author(s):  
Jingna An ◽  
Qixia Chen ◽  
Qianqian Liu ◽  
Chenli Rao ◽  
Dongdong Li ◽  
...  

ABSTRACTThe resurgence of syphilis in recent years has become a serious threat to public health worldwide, and the serological detection of specific antibodies againstTreponema pallidumremains the most reliable method for laboratory diagnosis of syphilis. This study examined the performance of the recently launched HISCL anti-Treponema pallidum(anti-TP) assay as a screening test for syphilis in a high-volume laboratory. The HISCL anti-TP assay was tested in 300 preselected syphilis-positive samples, 704 fresh syphilis-negative samples, 48 preselected potentially interfering samples, and 30 “borderline” samples and was compared head to head with the commercially available Lumipulse G TP-N. In this study, the HISCL anti-TP assay was in perfect agreement with the applied testing algorithms with an overall agreement of 100%, comparable to that of Lumipulse G TP-N (99.63%). The sensitivity and specificity of the HISCL anti-TP assay were 100% (95% confidence interval [CI], 98.42% to 100%) and 100% (95% CI, 99.37% to 100%), respectively. Considering the excellent ease of use and automation, high throughput, and its favorable sensitivity and specificity, the HISCL anti-TP assay may represent a new choice for syphilis screening in high-volume laboratories.


2010 ◽  
Vol 44 (5) ◽  
pp. 803-811 ◽  
Author(s):  
Valdiléa G Veloso ◽  
Francisco I Bastos ◽  
Margareth Crisóstomo Portela ◽  
Beatriz Grinsztejn ◽  
Esau Custodio João ◽  
...  

OBJECTIVE: To assess the feasibility of HIV rapid testing for pregnant women at maternity hospital admission and of subsequent interventions to reduce perinatal HIV transmission. METHODS: Study based on a convenience sample of women unaware of their HIV serostatus when they were admitted to delivery in public maternity hospitals in Rio de Janeiro and Porto Alegre, Brazil, between March 2000 and April 2002. Women were counseled and tested using the Determine HIV1/2 Rapid Test. HIV infection was confirmed using the Brazilian algorithm for HIV infection diagnosis. In utero transmission of HIV was determined using HIV-DNA-PCR. There were performed descriptive analyses of sociodemographic data, number of previous pregnancies and abortions, number of prenatal care visits, timing of HIV testing, HIV rapid test result, neonatal and mother-to-child transmission interventions, by city studied. RESULTS: HIV prevalence in women was 6.5% (N=1,439) in Porto Alegre and 1.3% (N=3.778) in Rio de Janeiro. In Porto Alegre most of women were tested during labor (88.7%), while in Rio de Janeiro most were tested in the postpartum (67.5%). One hundred and forty-four infants were born to 143 HIV-infected women. All newborns but one in each city received at least prophylaxis with oral zidovudine. It was possible to completely avoid newborn exposure to breast milk in 96.8% and 51.1% of the cases in Porto Alegre and Rio de Janeiro, respectively. Injectable intravenous zidovudine was administered during labor to 68.8% and 27.7% newborns in Porto Alegre and Rio de Janeiro, respectively. Among those from whom blood samples were collected within 48 hours of birth, in utero transmission of HIV was confirmed in 4 cases in Rio de Janeiro (4/47) and 6 cases in Porto Alegre (6/79). CONCLUSIONS: The strategy proved feasible in maternity hospitals in Rio de Janeiro and Porto Alegre. Efforts must be taken to maximize HIV testing during labor. There is a need of strong social support to provide this population access to health care services after hospital discharge.


2011 ◽  
Vol 18 (9) ◽  
pp. 1480-1485 ◽  
Author(s):  
Tania Crucitti ◽  
Doug Taylor ◽  
Greet Beelaert ◽  
Katrien Fransen ◽  
Lut Van Damme

ABSTRACTA multitest sequential algorithm based on rapid and simple (R/S) assays was applied for the diagnosis of HIV infection among participants in a phase 3 microbicide effectiveness trial. HIV testing was performed on finger-prick blood samples obtained from patients after their enrollment in the trial. The specimens were tested in a serial procedure using three different rapid tests (Determine HIV-1/2 [Abbott], SD Bioline HIV-1/2 3.0 [Standard Diagnostics], and Uni-Gold HIV [Trinity Biotech]). In the event of discordant results between the Determine HIV-1/2 and SD Bioline HIV-1/2 3.0 tests, the third assay (Uni-Gold HIV) determined the final outcome. When the final outcome was positive, a second specimen was collected and tested with the same algorithm, only if a positive result was obtained with this sample the participant was informed of her positive serostatus. A total of 5,734 postenrollment specimens obtained from 1,398 women were tested. Forty-six women tested positive according to the testing algorithm performed on the first collected specimen. Confirmatory testing results obtained at the ITM confirmed that 42 women were truly infected. Two of four initial false positives tested negative upon analysis of a second blood specimen. The other two tested false positive twice using specimens collected the same day. A high percentage of specimens reactive with the Determine HIV-1/2 assay was only observed at the study site in Kampala. This result did not appear to be associated with pregnancy or malaria infection. We conclude that HIV testing algorithms, including only R/S assays, are suitable for use in clinical trials, provided that adequate quality assurance procedures are in place.


2015 ◽  
Vol 70 ◽  
pp. S123-S124
Author(s):  
Gülden Çelik ◽  
Yeþim Gürol ◽  
Ýskender Karaltý ◽  
Sahap Aksaçlý ◽  
Burcu Öksüz ◽  
...  

2012 ◽  
Vol 5 (1) ◽  
Author(s):  
Steven Baveewo ◽  
Moses R Kamya ◽  
Harriet Mayanja-Kizza ◽  
Robin Fatch ◽  
David R Bangsberg ◽  
...  

2018 ◽  
Vol 47 (2) ◽  
pp. e15-e23 ◽  
Author(s):  
Hubert Demorat ◽  
Amanda Lopes ◽  
Dorothée Chopin ◽  
Véronique Delcey ◽  
Philippe Clevenbergh ◽  
...  

2018 ◽  
Vol 3 (1) ◽  
pp. 89-99 ◽  
Author(s):  
Robert H Christenson ◽  
Marvin Lessig ◽  
Gabrielle Miles ◽  
Silke Luebcke ◽  
Cheryl Stillions ◽  
...  

Abstract Background The Elecsys® syphilis immunoassay is an automated, qualitative immunoassay that uses a double-antigen sandwich format to detect antibodies to Treponema pallidum in human serum and plasma. We aimed to validate performance of the immunoassay in various populations at risk for syphilis infection in the US and Argentina. Methods Samples were obtained for a number of study cohorts, including participants from routine syphilis testing at high or low risk for syphilis, HIV-positive patients, pregnant women, and patients in various stages of syphilis infection. The primary objective was to validate the Elecsys syphilis immunoassay by comparing it with a composite testing algorithm using US Food and Drug Administration (FDA)-approved tests, including the predicate IMMULITE 2000 syphilis screening assay, the rapid plasma reagin, and the T. pallidum particle agglutination assay. Results Complete algorithm testing was performed on all 2660 collected samples. Acceptable precision was demonstrated in all samples. Comparison of the Elecsys syphilis immunoassay with the final syphilis status for all samples yielded a diagnostic sensitivity of 99.5% (95% CI, 98.21–99.94) and a diagnostic specificity of 99.2% (95% CI, 98.69–99.49). Overall, the lower limit of the 95% CIs for sensitivity and specificity met the expected performance of ≥95%. Conclusion This is the first study that confirms the high sensitivity and specificity of the Elecsys syphilis immunoassay in US and Argentinian cohorts and highlights the assay's usefulness as an alternative to current tests for the diagnosis of syphilis infection in a broad range of participant cohorts.


Jurnal INKOM ◽  
2014 ◽  
Vol 8 (1) ◽  
pp. 29 ◽  
Author(s):  
Arnida Lailatul Latifah ◽  
Adi Nurhadiyatna

This paper proposes parallel algorithms for precipitation of flood modelling, especially applied in spatial rainfall distribution. As an important input in flood modelling, spatial distribution of rainfall is always needed as a pre-conditioned model. In this paper two interpolation methods, Inverse distance weighting (IDW) and Ordinary kriging (OK) are discussed. Both are developed in parallel algorithms in order to reduce the computational time. To measure the computation efficiency, the performance of the parallel algorithms are compared to the serial algorithms for both methods. Findings indicate that: (1) the computation time of OK algorithm is up to 23% longer than IDW; (2) the computation time of OK and IDW algorithms is linearly increasing with the number of cells/ points; (3) the computation time of the parallel algorithms for both methods is exponentially decaying with the number of processors. The parallel algorithm of IDW gives a decay factor of 0.52, while OK gives 0.53; (4) The parallel algorithms perform near ideal speed-up.


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