Assessing the sensitivity and specificity of First Response HIV-1-2 test kit with whole blood and serum samples: a cross-sectional study

Boadu, Raymond; Darko, George; Nortey, Priscilla; Akweongo, Patricia; Sarfo, Bismark

doi:10.1186/s12981-016-0092-0

Cited by 16 publications

(15 citation statements)

References 20 publications

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“…The use of Oraquick Advance Rapid HIV-1/2 antibody test is consistent with the confirmatory testing protocol for HIV in Ghana [30]. …”

Section: Methodsmentioning

confidence: 89%

“…Blood samples of hospital participants were further tested for HIV using INSTANTCHEK HIV-1 + 2 rapid diagnostic test kit by EY Laboratories and Oraquick Advance Rapid HIV-1/2 antibody test by OraSure Technologies, Inc. The use of Oraquick Advance Rapid HIV-1/2 antibody test is consistent with the confirmatory testing protocol for HIV in Ghana [ 30 ].…”

Section: Methodsmentioning

confidence: 99%

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Prevalence of Plasmodium falciparum and non-P. falciparum infections in a highland district in Ghana, and the influence of HIV and sickle cell disease

Owusu

Brown

Grobusch

et al. 2017

Malar J

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BackgroundIn the past two decades, there has been a reported decline in malaria in Ghana and the rest of the world; yet it remains the number one cause of mortality and morbidity. Human immuno-deficiency virus (HIV) and sickle cell disease (SCD) share a common geographical space with malaria in sub-Saharan Africa and an interaction between these three conditions has been suggested. This study determined the Plasmodium falciparum and non-P. falciparum status of symptomatic and non-symptomatic residents of Mpraeso in the highlands of Kwahu-South district of Ghana based on evidence of current national decline. The influence of HIV and SCD on malaria was also determined.MethodsParticipants were 354 symptomatic patients visiting the Kwahu Government Hospital and 360 asymptomatic residents of the district capital. This cross-sectional study was conducted during the minor rainy season (October–December 2014). Rapid diagnostic tests (RDT), blood film microscopy and real-time polymerase chain reaction assessment of blood were done. Participants who tested positive with RDT were treated with artemisinin-based combination therapy; and assessment of venous blood was repeated 7 days after treatment. HIV screening and haemoglobin genotyping was done. Univariate and multivariate regression analysis was used to determine the influence of SCD and HIV.Results Plasmodium falciparum was prevalent at 124/142 (87.3%). Plasmodium malariae was the only non-falciparum species detected at 18/142 (12.7%). HIV and SCD did not significantly increase odds of malaria infection. However, the use of ITN and recent anti-malarial intake significantly decreased the odds of being malaria infected by 0.45-fold and 0.46-fold respectively.Conclusion Plasmodium falciparum and P. malariae infection are the prevailing species in the study area; albeit varying from the national average. HIV and SCD were not associated with the risk of having malaria.Electronic supplementary materialThe online version of this article (doi:10.1186/s12936-017-1823-y) contains supplementary material, which is available to authorized users.

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“…The use of Oraquick Advance Rapid HIV-1/2 antibody test is consistent with the confirmatory testing protocol for HIV in Ghana [30]. …”

Section: Methodsmentioning

confidence: 89%

Section: Methodsmentioning

confidence: 99%

Prevalence of Plasmodium falciparum and non-P. falciparum infections in a highland district in Ghana, and the influence of HIV and sickle cell disease

Owusu

Brown

Grobusch

et al. 2017

Malar J

View full text Add to dashboard Cite

show abstract

“…used plasma samples that had been frozen, shipped and stored, whereas RDTs, while often validated for serum and plasma, are designed to be used with fresh specimens, typically capillary whole blood. While the limited data available do not indicate clear discordance with the testing results from previously frozen samples, as noted by the authors, “some studies have shown differences in sensitivity and specificity when using plasma/serum compared to capillary whole blood,” which could be postulated to have had an impact on the results seen .…”

Section: Discussionmentioning

confidence: 93%

A Commitment to HIV Diagnostic Accuracy – a comment on “Towards more accurate HIV testing in sub‐Saharan Africa: a multi‐site evaluation of HIV RDTs and risk factors for false positives” and “HIV misdiagnosis in sub‐Saharan Africa: a performance of diagnostic algorithms at six testing sites”

et al. 2018

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As part of the global response to the HIV/AIDS epidemic, the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) is committed to the provision of high‐quality services and ensuring testing accuracy. Two recently published papers focusing on HIV testing and misdiagnosis in sub‐Saharan Africa by Kosack et al. report on evaluations of HIV rapid diagnostic tests (RDTs) and found lower than expected specificity and sensitivity on some tests when used in certain geographic locations. The magnitude of PEPFAR's global HIV response has been possible due to the extensive use of RDTs, which have made HIV diagnosis accessible all over the world. We take the opportunity to address concerns raised about the potential implications that these findings could have on real‐world HIV testing accuracy. PEPFAR supported countries adhere to the normative guidance by World Health Organization (WHO) supporting algorithms which require sequential positive tests for diagnostic accuracy. An analysis of Médecins Sans Frontières (MSF) RDT site‐specific data applied to PEPFAR in‐country protocols demonstrate a variation in the diagnostic accuracy of the testing algorithms, but with a very small population‐level effect. The data demonstrate, with the use of these algorithms, that the RDT outcomes found in the study by Kosack et al. would be largely mitigated and would not be expected to have a significant impact on diagnostic accuracy and overall programming in most countries. Avoiding any misdiagnosis is a priority for PEPFAR, and it remains vital to gain a deeper understanding of the causes and the extent of diagnostic errors and any misclassification. Extensive quality control mechanisms and continued research are essential. With a focus on epidemic control and ensuring diagnostic accuracy, PEPFAR recommends that all countries use WHO pre‐qualified RDTs within the recommended strategies and algorithms for HIV testing. We also support validation of HIV testing algorithms using in‐country specimens to determine optimal performance, and the reverification testing of all people diagnosed with HIV prior to starting treatment as an essential quality assurance measure.

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“…For comparison, rapid diagnostic tests (RDTs) for HIV are reported to have 99% specificity, 32 , 33 but at least one RDT (First Response) had 100% specificity on whole blood but 82.86% specificity with serum specimen for HIV-1. 34 Comparing results with serum specimen, the HIV test would generate far more false positives than the Chagas RDT with serum that was used for estimating cost stated earlier.…”

Section: Discussionmentioning

confidence: 99%

Congenital Chagas Disease in the United States: Cost Savings through Maternal Screening

Stillwaggon

Perez-Zetune

Bialek

et al. 2018

The American Journal of Tropical Medicine and Hygiene

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Abstract.Chagas disease, caused by Trypanosoma cruzi, is transmitted by insect vectors through transfusions, transplants, insect feces in food, and from mother to child during gestation. Congenital infection could perpetuate Chagas disease indefinitely, even in countries without vector transmission. An estimated 30% of infected persons will develop lifelong, potentially fatal, cardiac or digestive complications. Treatment of infants with benznidazole is highly efficacious in eliminating infection. This work evaluates the costs of maternal screening and infant testing and treatment of Chagas disease in the United States. We constructed a decision-analytic model to find the lower cost option, comparing costs of testing and treatment, as needed, for mothers and infants with the lifetime societal costs without testing and the consequent morbidity and mortality due to lack of treatment or late treatment. We found that maternal screening, infant testing, and treatment of Chagas disease in the United States are cost saving for all rates of congenital transmission greater than 0.001% and all levels of maternal prevalence above 0.06% compared with no screening program. Newly approved diagnostics make universal screening cost saving with maternal prevalence as low as 0.008%. The present value of lifetime societal savings due to screening and treatment is about $634 million saved for every birth year cohort. The benefits of universal screening for T. cruzi as part of routine prenatal testing far outweigh the program costs for all U.S. births.

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Assessing the sensitivity and specificity of First Response HIV-1-2 test kit with whole blood and serum samples: a cross-sectional study

Cited by 16 publications

References 20 publications

Prevalence of Plasmodium falciparum and non-P. falciparum infections in a highland district in Ghana, and the influence of HIV and sickle cell disease

Prevalence of Plasmodium falciparum and non-P. falciparum infections in a highland district in Ghana, and the influence of HIV and sickle cell disease

Congenital Chagas Disease in the United States: Cost Savings through Maternal Screening

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