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Field comparison of OraQuick ADVANCE Rapid HIV-1/2 antibody test and two blood-based rapid HIV antibody tests in Zambia.

Zachary D, Mwenge L, Muyoyeta M, Shanaube K, Schaap A, Bond V, Kosloff B, de Haas P, Ayles H - BMC Infect. Dis. (2012)

Bottom Line: The sensitivity and specificity of the OraQuick test were 98.7 (95%CI, 97.5-99.4) and 99.8 (95%CI, 99.6-99.9), respectively when compared to HIV positive serostatus.The current Determine/Uni-Gold testing algorithm is the least expensive when compared to Determine/OraQuick, OraQuick/Determine, and OraQuick/Uni-Gold in the Zambian setting.From our field experience, oral fluid based testing offers many advantages over blood-based testing, especially with self testing on the horizon.

View Article: PubMed Central - HTML - PubMed

Affiliation: ZAMBART Project, University of Zambia, Nationalist Road, Ridgeway, Lusaka, Zambia. dalila@zambart.org.zm

ABSTRACT

Background: Zambia's national HIV testing algorithm specifies use of two rapid blood based antibody assays, DetermineHIV-1/2 (Inverness Medical) and if positive then Uni-Gold Recombigen HIV-1/2 (Trinity Biotech). Little is known about the performance of oral fluid based HIV testing in Zambia. The aims of this study are two-fold: 1) to compare the diagnostic accuracy (sensitivity and specificity) under field conditions of the OraQuick ADVANCE Rapid HIV-1/2 (OraSure Technologies, Inc.) to two blood-based rapid antibody tests currently in use in the Zambia National Algorithm, and 2) to perform a cost analysis of large-scale field testing employing the OraQuick.

Methods: This was a operational retrospective research of HIV testing and questionnaire data collected in 2010 as part of the ZAMSTAR (Zambia South Africa TB and AIDS reduction) study. Randomly sampled individuals in twelve communities were tested consecutively with OraQuick test using oral fluid versus two blood-based rapid HIV tests, Determine and Uni-Gold. A cost analysis of four algorithms from health systems perspective were performed: 1) Determine and if positive, then Uni-Gold (Determine/Uni-Gold); based on current algorithm, 2) Determine and if positive, then OraQuick (Determine/OraQuick), 3) OraQuick and if positive, then Determine (OraQuick/Determine), 4) OraQuick and if positive, then Uni-Gold (OraQuick/Uni-Gold). This information was then used to construct a model using a hypothetical population of 5,000 persons with varying prevalence of HIV infection from 1-30%.

Results: 4,458 participants received both a Determine and OraQuick test. The sensitivity and specificity of the OraQuick test were 98.7 (95%CI, 97.5-99.4) and 99.8 (95%CI, 99.6-99.9), respectively when compared to HIV positive serostatus. The average unit costs per algorithm were US$3.76, US$4.03, US$7.35, and US$7.67 for Determine/Uni-Gold, Determine/OraQuick, OraQuick/Determine, and OraQuick/Uni-Gold, respectively, for an HIV prevalence of 15%.

Conclusions: An alternative HIV testing algorithm could include OraQuick test which had a high sensitivity and specificity. The current Determine/Uni-Gold testing algorithm is the least expensive when compared to Determine/OraQuick, OraQuick/Determine, and OraQuick/Uni-Gold in the Zambian setting. From our field experience, oral fluid based testing offers many advantages over blood-based testing, especially with self testing on the horizon.

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HIV testing algorithm. A If patient self reported Positive HIV status prior to testing then Uni-GoldTM testing was not performed and patient was referred to local ART clinic. B Patient told about the “window period” and asked to repeat test in 3 months. C Patient was referred for care at local ART clinic. D Patient was referred for further testing via routine VCT centers.
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Figure 1: HIV testing algorithm. A If patient self reported Positive HIV status prior to testing then Uni-GoldTM testing was not performed and patient was referred to local ART clinic. B Patient told about the “window period” and asked to repeat test in 3 months. C Patient was referred for care at local ART clinic. D Patient was referred for further testing via routine VCT centers.

Mentions: Of the sixteen ZAMSTAR study communities, twelve were conveniently sampled to take part in this field comparison study. Randomly sampled individuals in twelve communities in Zambia were tested consecutively from April 29, 2010 to August 13, 2010 in their homes for HIV using both the oral fluid and blood-based rapid assays (Figure 1). All steps in the HIV testing process (pre-test counseling, sample collection, performance of assays, interpretation of results, presentation of results and post-test counseling) were performed in the participants’ homes by qualified counselors. The twelve selected sites were mostly urban communities and one rural community.


Field comparison of OraQuick ADVANCE Rapid HIV-1/2 antibody test and two blood-based rapid HIV antibody tests in Zambia.

Zachary D, Mwenge L, Muyoyeta M, Shanaube K, Schaap A, Bond V, Kosloff B, de Haas P, Ayles H - BMC Infect. Dis. (2012)

HIV testing algorithm. A If patient self reported Positive HIV status prior to testing then Uni-GoldTM testing was not performed and patient was referred to local ART clinic. B Patient told about the “window period” and asked to repeat test in 3 months. C Patient was referred for care at local ART clinic. D Patient was referred for further testing via routine VCT centers.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3475053&req=5

Figure 1: HIV testing algorithm. A If patient self reported Positive HIV status prior to testing then Uni-GoldTM testing was not performed and patient was referred to local ART clinic. B Patient told about the “window period” and asked to repeat test in 3 months. C Patient was referred for care at local ART clinic. D Patient was referred for further testing via routine VCT centers.
Mentions: Of the sixteen ZAMSTAR study communities, twelve were conveniently sampled to take part in this field comparison study. Randomly sampled individuals in twelve communities in Zambia were tested consecutively from April 29, 2010 to August 13, 2010 in their homes for HIV using both the oral fluid and blood-based rapid assays (Figure 1). All steps in the HIV testing process (pre-test counseling, sample collection, performance of assays, interpretation of results, presentation of results and post-test counseling) were performed in the participants’ homes by qualified counselors. The twelve selected sites were mostly urban communities and one rural community.

Bottom Line: The sensitivity and specificity of the OraQuick test were 98.7 (95%CI, 97.5-99.4) and 99.8 (95%CI, 99.6-99.9), respectively when compared to HIV positive serostatus.The current Determine/Uni-Gold testing algorithm is the least expensive when compared to Determine/OraQuick, OraQuick/Determine, and OraQuick/Uni-Gold in the Zambian setting.From our field experience, oral fluid based testing offers many advantages over blood-based testing, especially with self testing on the horizon.

View Article: PubMed Central - HTML - PubMed

Affiliation: ZAMBART Project, University of Zambia, Nationalist Road, Ridgeway, Lusaka, Zambia. dalila@zambart.org.zm

ABSTRACT

Background: Zambia's national HIV testing algorithm specifies use of two rapid blood based antibody assays, DetermineHIV-1/2 (Inverness Medical) and if positive then Uni-Gold Recombigen HIV-1/2 (Trinity Biotech). Little is known about the performance of oral fluid based HIV testing in Zambia. The aims of this study are two-fold: 1) to compare the diagnostic accuracy (sensitivity and specificity) under field conditions of the OraQuick ADVANCE Rapid HIV-1/2 (OraSure Technologies, Inc.) to two blood-based rapid antibody tests currently in use in the Zambia National Algorithm, and 2) to perform a cost analysis of large-scale field testing employing the OraQuick.

Methods: This was a operational retrospective research of HIV testing and questionnaire data collected in 2010 as part of the ZAMSTAR (Zambia South Africa TB and AIDS reduction) study. Randomly sampled individuals in twelve communities were tested consecutively with OraQuick test using oral fluid versus two blood-based rapid HIV tests, Determine and Uni-Gold. A cost analysis of four algorithms from health systems perspective were performed: 1) Determine and if positive, then Uni-Gold (Determine/Uni-Gold); based on current algorithm, 2) Determine and if positive, then OraQuick (Determine/OraQuick), 3) OraQuick and if positive, then Determine (OraQuick/Determine), 4) OraQuick and if positive, then Uni-Gold (OraQuick/Uni-Gold). This information was then used to construct a model using a hypothetical population of 5,000 persons with varying prevalence of HIV infection from 1-30%.

Results: 4,458 participants received both a Determine and OraQuick test. The sensitivity and specificity of the OraQuick test were 98.7 (95%CI, 97.5-99.4) and 99.8 (95%CI, 99.6-99.9), respectively when compared to HIV positive serostatus. The average unit costs per algorithm were US$3.76, US$4.03, US$7.35, and US$7.67 for Determine/Uni-Gold, Determine/OraQuick, OraQuick/Determine, and OraQuick/Uni-Gold, respectively, for an HIV prevalence of 15%.

Conclusions: An alternative HIV testing algorithm could include OraQuick test which had a high sensitivity and specificity. The current Determine/Uni-Gold testing algorithm is the least expensive when compared to Determine/OraQuick, OraQuick/Determine, and OraQuick/Uni-Gold in the Zambian setting. From our field experience, oral fluid based testing offers many advantages over blood-based testing, especially with self testing on the horizon.

Show MeSH
Related in: MedlinePlus