Sensitivity and specificity of OraQuick® HIV self-test compared to a 4th generation laboratory reference standard algorithm in urban and rural Zambia
Background HIV self-testing (HIVST) has the potential to increase coverage of HIV testing, but concerns exist about intended users’ ability to correctly perform and interpret tests, especially in poor communities with low literacy rates. We assessed the clinical performance of the 2016 prototype Ora...
Ausführliche Beschreibung
Autor*in: |
Neuman, Melissa [verfasserIn] |
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Englisch |
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2022 |
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© The Author(s) 2022 |
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Übergeordnetes Werk: |
Enthalten in: BMC infectious diseases - London : BioMed Central, 2001, 22(2022), Suppl 1 vom: 25. Mai |
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Übergeordnetes Werk: |
volume:22 ; year:2022 ; number:Suppl 1 ; day:25 ; month:05 |
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DOI / URN: |
10.1186/s12879-022-07457-5 |
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SPR050737805 |
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520 | |a Background HIV self-testing (HIVST) has the potential to increase coverage of HIV testing, but concerns exist about intended users’ ability to correctly perform and interpret tests, especially in poor communities with low literacy rates. We assessed the clinical performance of the 2016 prototype OraQuick® HIV Self-Test in rural and urban communities in Zambia to assess the sensitivity and specificity of the test compared to the national HIV rapid diagnostic test (RDT) algorithm and a laboratory reference standard using 4th generation enzyme immunoassays and HIV RNA detection. Methods Participants were recruited from randomly selected rural and urban households and one urban health facility between May 2016 and June 2017. Participants received a brief demonstration of the self-test, and then self-tested without further assistance. The research team re-read the self-test, repeated the self-test, drew blood for the laboratory reference, and conducted RDTs following the national HIV testing algorithm (Determine™ HIV1/2 (Alere) confirmed using Unigold™ HIV1/2 (Trinity Biotech)). Selected participants (N = 85) were videotaped whilst conducting the testing to observe common errors. Results Initial piloting showed that written instructions alone were inadequate, and a demonstration of self-test use was required. Of 2,566 self-test users, 2,557 (99.6%) were able to interpret their result. Of participants who were videoed 75/84 (89.3%) completed all steps of the procedure correctly. Agreement between the user-read result and the researcher-read result was 99.1%. Compared to the RDT algorithm, user-conducted HIVST was 94.1% sensitive (95%CI: 90.2–96.7) and 99.7% specific (95%CI: 99.3–99.9). Compared to the laboratory reference, both user-conducted HIVST (sensitivity 87.5%, 95%CI: 82.70–91.3; specificity 99.7%, 95%CI: 99.4–99.9) and the national RDT algorithm (sensitivity 93.4%, 95%CI: 89.7–96.1%; specificity 100% (95%CI: 99.8–100%) had considerably lower sensitivity. Conclusions Self-testers in Zambia who used OraQuick® HIV Self-Test achieved reasonable clinical performance compared to the national RDT algorithm. However, sensitivity of the self-test was reduced compared to a laboratory reference standard, as was the national RDT algorithm. In-person demonstration, along with the written manufacturer instructions, was needed to obtain accurate results. Programmes introducing self-care diagnostics should pilot and optimise support materials to ensure they are appropriately adapted to context. | ||
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650 | 4 | |a HIV |7 (dpeaa)DE-He213 | |
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650 | 4 | |a In vitro diagnostics |7 (dpeaa)DE-He213 | |
650 | 4 | |a Self-care |7 (dpeaa)DE-He213 | |
700 | 1 | |a Mwinga, Alwyn |4 aut | |
700 | 1 | |a Kapaku, Kezia |4 aut | |
700 | 1 | |a Sigande, Lucheka |4 aut | |
700 | 1 | |a Gotsche, Caroline |4 aut | |
700 | 1 | |a Taegtmeyer, Miriam |4 aut | |
700 | 1 | |a Dacombe, Russell |4 aut | |
700 | 1 | |a Maluzi, Kwitaka |4 aut | |
700 | 1 | |a Kosloff, Barry |4 aut | |
700 | 1 | |a Johnson, Cheryl |4 aut | |
700 | 1 | |a Hatzold, Karin |4 aut | |
700 | 1 | |a Corbett, Elizabeth L. |4 aut | |
700 | 1 | |a Ayles, Helen |4 aut | |
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10.1186/s12879-022-07457-5 doi (DE-627)SPR050737805 (SPR)s12879-022-07457-5-e DE-627 ger DE-627 rakwb eng Neuman, Melissa verfasserin (orcid)0000-0002-8870-6504 aut Sensitivity and specificity of OraQuick® HIV self-test compared to a 4th generation laboratory reference standard algorithm in urban and rural Zambia 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Background HIV self-testing (HIVST) has the potential to increase coverage of HIV testing, but concerns exist about intended users’ ability to correctly perform and interpret tests, especially in poor communities with low literacy rates. We assessed the clinical performance of the 2016 prototype OraQuick® HIV Self-Test in rural and urban communities in Zambia to assess the sensitivity and specificity of the test compared to the national HIV rapid diagnostic test (RDT) algorithm and a laboratory reference standard using 4th generation enzyme immunoassays and HIV RNA detection. Methods Participants were recruited from randomly selected rural and urban households and one urban health facility between May 2016 and June 2017. Participants received a brief demonstration of the self-test, and then self-tested without further assistance. The research team re-read the self-test, repeated the self-test, drew blood for the laboratory reference, and conducted RDTs following the national HIV testing algorithm (Determine™ HIV1/2 (Alere) confirmed using Unigold™ HIV1/2 (Trinity Biotech)). Selected participants (N = 85) were videotaped whilst conducting the testing to observe common errors. Results Initial piloting showed that written instructions alone were inadequate, and a demonstration of self-test use was required. Of 2,566 self-test users, 2,557 (99.6%) were able to interpret their result. Of participants who were videoed 75/84 (89.3%) completed all steps of the procedure correctly. Agreement between the user-read result and the researcher-read result was 99.1%. Compared to the RDT algorithm, user-conducted HIVST was 94.1% sensitive (95%CI: 90.2–96.7) and 99.7% specific (95%CI: 99.3–99.9). Compared to the laboratory reference, both user-conducted HIVST (sensitivity 87.5%, 95%CI: 82.70–91.3; specificity 99.7%, 95%CI: 99.4–99.9) and the national RDT algorithm (sensitivity 93.4%, 95%CI: 89.7–96.1%; specificity 100% (95%CI: 99.8–100%) had considerably lower sensitivity. Conclusions Self-testers in Zambia who used OraQuick® HIV Self-Test achieved reasonable clinical performance compared to the national RDT algorithm. However, sensitivity of the self-test was reduced compared to a laboratory reference standard, as was the national RDT algorithm. In-person demonstration, along with the written manufacturer instructions, was needed to obtain accurate results. Programmes introducing self-care diagnostics should pilot and optimise support materials to ensure they are appropriately adapted to context. HIV self-testing (dpeaa)DE-He213 HIV (dpeaa)DE-He213 Diagnostic tests (dpeaa)DE-He213 In vitro diagnostics (dpeaa)DE-He213 Self-care (dpeaa)DE-He213 Mwinga, Alwyn aut Kapaku, Kezia aut Sigande, Lucheka aut Gotsche, Caroline aut Taegtmeyer, Miriam aut Dacombe, Russell aut Maluzi, Kwitaka aut Kosloff, Barry aut Johnson, Cheryl aut Hatzold, Karin aut Corbett, Elizabeth L. aut Ayles, Helen aut Enthalten in BMC infectious diseases London : BioMed Central, 2001 22(2022), Suppl 1 vom: 25. Mai (DE-627)326645381 (DE-600)2041550-3 1471-2334 nnns volume:22 year:2022 number:Suppl 1 day:25 month:05 https://dx.doi.org/10.1186/s12879-022-07457-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 22 2022 Suppl 1 25 05 |
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10.1186/s12879-022-07457-5 doi (DE-627)SPR050737805 (SPR)s12879-022-07457-5-e DE-627 ger DE-627 rakwb eng Neuman, Melissa verfasserin (orcid)0000-0002-8870-6504 aut Sensitivity and specificity of OraQuick® HIV self-test compared to a 4th generation laboratory reference standard algorithm in urban and rural Zambia 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Background HIV self-testing (HIVST) has the potential to increase coverage of HIV testing, but concerns exist about intended users’ ability to correctly perform and interpret tests, especially in poor communities with low literacy rates. We assessed the clinical performance of the 2016 prototype OraQuick® HIV Self-Test in rural and urban communities in Zambia to assess the sensitivity and specificity of the test compared to the national HIV rapid diagnostic test (RDT) algorithm and a laboratory reference standard using 4th generation enzyme immunoassays and HIV RNA detection. Methods Participants were recruited from randomly selected rural and urban households and one urban health facility between May 2016 and June 2017. Participants received a brief demonstration of the self-test, and then self-tested without further assistance. The research team re-read the self-test, repeated the self-test, drew blood for the laboratory reference, and conducted RDTs following the national HIV testing algorithm (Determine™ HIV1/2 (Alere) confirmed using Unigold™ HIV1/2 (Trinity Biotech)). Selected participants (N = 85) were videotaped whilst conducting the testing to observe common errors. Results Initial piloting showed that written instructions alone were inadequate, and a demonstration of self-test use was required. Of 2,566 self-test users, 2,557 (99.6%) were able to interpret their result. Of participants who were videoed 75/84 (89.3%) completed all steps of the procedure correctly. Agreement between the user-read result and the researcher-read result was 99.1%. Compared to the RDT algorithm, user-conducted HIVST was 94.1% sensitive (95%CI: 90.2–96.7) and 99.7% specific (95%CI: 99.3–99.9). Compared to the laboratory reference, both user-conducted HIVST (sensitivity 87.5%, 95%CI: 82.70–91.3; specificity 99.7%, 95%CI: 99.4–99.9) and the national RDT algorithm (sensitivity 93.4%, 95%CI: 89.7–96.1%; specificity 100% (95%CI: 99.8–100%) had considerably lower sensitivity. Conclusions Self-testers in Zambia who used OraQuick® HIV Self-Test achieved reasonable clinical performance compared to the national RDT algorithm. However, sensitivity of the self-test was reduced compared to a laboratory reference standard, as was the national RDT algorithm. In-person demonstration, along with the written manufacturer instructions, was needed to obtain accurate results. Programmes introducing self-care diagnostics should pilot and optimise support materials to ensure they are appropriately adapted to context. HIV self-testing (dpeaa)DE-He213 HIV (dpeaa)DE-He213 Diagnostic tests (dpeaa)DE-He213 In vitro diagnostics (dpeaa)DE-He213 Self-care (dpeaa)DE-He213 Mwinga, Alwyn aut Kapaku, Kezia aut Sigande, Lucheka aut Gotsche, Caroline aut Taegtmeyer, Miriam aut Dacombe, Russell aut Maluzi, Kwitaka aut Kosloff, Barry aut Johnson, Cheryl aut Hatzold, Karin aut Corbett, Elizabeth L. aut Ayles, Helen aut Enthalten in BMC infectious diseases London : BioMed Central, 2001 22(2022), Suppl 1 vom: 25. Mai (DE-627)326645381 (DE-600)2041550-3 1471-2334 nnns volume:22 year:2022 number:Suppl 1 day:25 month:05 https://dx.doi.org/10.1186/s12879-022-07457-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 22 2022 Suppl 1 25 05 |
allfields_unstemmed |
10.1186/s12879-022-07457-5 doi (DE-627)SPR050737805 (SPR)s12879-022-07457-5-e DE-627 ger DE-627 rakwb eng Neuman, Melissa verfasserin (orcid)0000-0002-8870-6504 aut Sensitivity and specificity of OraQuick® HIV self-test compared to a 4th generation laboratory reference standard algorithm in urban and rural Zambia 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Background HIV self-testing (HIVST) has the potential to increase coverage of HIV testing, but concerns exist about intended users’ ability to correctly perform and interpret tests, especially in poor communities with low literacy rates. We assessed the clinical performance of the 2016 prototype OraQuick® HIV Self-Test in rural and urban communities in Zambia to assess the sensitivity and specificity of the test compared to the national HIV rapid diagnostic test (RDT) algorithm and a laboratory reference standard using 4th generation enzyme immunoassays and HIV RNA detection. Methods Participants were recruited from randomly selected rural and urban households and one urban health facility between May 2016 and June 2017. Participants received a brief demonstration of the self-test, and then self-tested without further assistance. The research team re-read the self-test, repeated the self-test, drew blood for the laboratory reference, and conducted RDTs following the national HIV testing algorithm (Determine™ HIV1/2 (Alere) confirmed using Unigold™ HIV1/2 (Trinity Biotech)). Selected participants (N = 85) were videotaped whilst conducting the testing to observe common errors. Results Initial piloting showed that written instructions alone were inadequate, and a demonstration of self-test use was required. Of 2,566 self-test users, 2,557 (99.6%) were able to interpret their result. Of participants who were videoed 75/84 (89.3%) completed all steps of the procedure correctly. Agreement between the user-read result and the researcher-read result was 99.1%. Compared to the RDT algorithm, user-conducted HIVST was 94.1% sensitive (95%CI: 90.2–96.7) and 99.7% specific (95%CI: 99.3–99.9). Compared to the laboratory reference, both user-conducted HIVST (sensitivity 87.5%, 95%CI: 82.70–91.3; specificity 99.7%, 95%CI: 99.4–99.9) and the national RDT algorithm (sensitivity 93.4%, 95%CI: 89.7–96.1%; specificity 100% (95%CI: 99.8–100%) had considerably lower sensitivity. Conclusions Self-testers in Zambia who used OraQuick® HIV Self-Test achieved reasonable clinical performance compared to the national RDT algorithm. However, sensitivity of the self-test was reduced compared to a laboratory reference standard, as was the national RDT algorithm. In-person demonstration, along with the written manufacturer instructions, was needed to obtain accurate results. Programmes introducing self-care diagnostics should pilot and optimise support materials to ensure they are appropriately adapted to context. HIV self-testing (dpeaa)DE-He213 HIV (dpeaa)DE-He213 Diagnostic tests (dpeaa)DE-He213 In vitro diagnostics (dpeaa)DE-He213 Self-care (dpeaa)DE-He213 Mwinga, Alwyn aut Kapaku, Kezia aut Sigande, Lucheka aut Gotsche, Caroline aut Taegtmeyer, Miriam aut Dacombe, Russell aut Maluzi, Kwitaka aut Kosloff, Barry aut Johnson, Cheryl aut Hatzold, Karin aut Corbett, Elizabeth L. aut Ayles, Helen aut Enthalten in BMC infectious diseases London : BioMed Central, 2001 22(2022), Suppl 1 vom: 25. Mai (DE-627)326645381 (DE-600)2041550-3 1471-2334 nnns volume:22 year:2022 number:Suppl 1 day:25 month:05 https://dx.doi.org/10.1186/s12879-022-07457-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 22 2022 Suppl 1 25 05 |
allfieldsGer |
10.1186/s12879-022-07457-5 doi (DE-627)SPR050737805 (SPR)s12879-022-07457-5-e DE-627 ger DE-627 rakwb eng Neuman, Melissa verfasserin (orcid)0000-0002-8870-6504 aut Sensitivity and specificity of OraQuick® HIV self-test compared to a 4th generation laboratory reference standard algorithm in urban and rural Zambia 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Background HIV self-testing (HIVST) has the potential to increase coverage of HIV testing, but concerns exist about intended users’ ability to correctly perform and interpret tests, especially in poor communities with low literacy rates. We assessed the clinical performance of the 2016 prototype OraQuick® HIV Self-Test in rural and urban communities in Zambia to assess the sensitivity and specificity of the test compared to the national HIV rapid diagnostic test (RDT) algorithm and a laboratory reference standard using 4th generation enzyme immunoassays and HIV RNA detection. Methods Participants were recruited from randomly selected rural and urban households and one urban health facility between May 2016 and June 2017. Participants received a brief demonstration of the self-test, and then self-tested without further assistance. The research team re-read the self-test, repeated the self-test, drew blood for the laboratory reference, and conducted RDTs following the national HIV testing algorithm (Determine™ HIV1/2 (Alere) confirmed using Unigold™ HIV1/2 (Trinity Biotech)). Selected participants (N = 85) were videotaped whilst conducting the testing to observe common errors. Results Initial piloting showed that written instructions alone were inadequate, and a demonstration of self-test use was required. Of 2,566 self-test users, 2,557 (99.6%) were able to interpret their result. Of participants who were videoed 75/84 (89.3%) completed all steps of the procedure correctly. Agreement between the user-read result and the researcher-read result was 99.1%. Compared to the RDT algorithm, user-conducted HIVST was 94.1% sensitive (95%CI: 90.2–96.7) and 99.7% specific (95%CI: 99.3–99.9). Compared to the laboratory reference, both user-conducted HIVST (sensitivity 87.5%, 95%CI: 82.70–91.3; specificity 99.7%, 95%CI: 99.4–99.9) and the national RDT algorithm (sensitivity 93.4%, 95%CI: 89.7–96.1%; specificity 100% (95%CI: 99.8–100%) had considerably lower sensitivity. Conclusions Self-testers in Zambia who used OraQuick® HIV Self-Test achieved reasonable clinical performance compared to the national RDT algorithm. However, sensitivity of the self-test was reduced compared to a laboratory reference standard, as was the national RDT algorithm. In-person demonstration, along with the written manufacturer instructions, was needed to obtain accurate results. Programmes introducing self-care diagnostics should pilot and optimise support materials to ensure they are appropriately adapted to context. HIV self-testing (dpeaa)DE-He213 HIV (dpeaa)DE-He213 Diagnostic tests (dpeaa)DE-He213 In vitro diagnostics (dpeaa)DE-He213 Self-care (dpeaa)DE-He213 Mwinga, Alwyn aut Kapaku, Kezia aut Sigande, Lucheka aut Gotsche, Caroline aut Taegtmeyer, Miriam aut Dacombe, Russell aut Maluzi, Kwitaka aut Kosloff, Barry aut Johnson, Cheryl aut Hatzold, Karin aut Corbett, Elizabeth L. aut Ayles, Helen aut Enthalten in BMC infectious diseases London : BioMed Central, 2001 22(2022), Suppl 1 vom: 25. Mai (DE-627)326645381 (DE-600)2041550-3 1471-2334 nnns volume:22 year:2022 number:Suppl 1 day:25 month:05 https://dx.doi.org/10.1186/s12879-022-07457-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 22 2022 Suppl 1 25 05 |
allfieldsSound |
10.1186/s12879-022-07457-5 doi (DE-627)SPR050737805 (SPR)s12879-022-07457-5-e DE-627 ger DE-627 rakwb eng Neuman, Melissa verfasserin (orcid)0000-0002-8870-6504 aut Sensitivity and specificity of OraQuick® HIV self-test compared to a 4th generation laboratory reference standard algorithm in urban and rural Zambia 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s) 2022 Background HIV self-testing (HIVST) has the potential to increase coverage of HIV testing, but concerns exist about intended users’ ability to correctly perform and interpret tests, especially in poor communities with low literacy rates. We assessed the clinical performance of the 2016 prototype OraQuick® HIV Self-Test in rural and urban communities in Zambia to assess the sensitivity and specificity of the test compared to the national HIV rapid diagnostic test (RDT) algorithm and a laboratory reference standard using 4th generation enzyme immunoassays and HIV RNA detection. Methods Participants were recruited from randomly selected rural and urban households and one urban health facility between May 2016 and June 2017. Participants received a brief demonstration of the self-test, and then self-tested without further assistance. The research team re-read the self-test, repeated the self-test, drew blood for the laboratory reference, and conducted RDTs following the national HIV testing algorithm (Determine™ HIV1/2 (Alere) confirmed using Unigold™ HIV1/2 (Trinity Biotech)). Selected participants (N = 85) were videotaped whilst conducting the testing to observe common errors. Results Initial piloting showed that written instructions alone were inadequate, and a demonstration of self-test use was required. Of 2,566 self-test users, 2,557 (99.6%) were able to interpret their result. Of participants who were videoed 75/84 (89.3%) completed all steps of the procedure correctly. Agreement between the user-read result and the researcher-read result was 99.1%. Compared to the RDT algorithm, user-conducted HIVST was 94.1% sensitive (95%CI: 90.2–96.7) and 99.7% specific (95%CI: 99.3–99.9). Compared to the laboratory reference, both user-conducted HIVST (sensitivity 87.5%, 95%CI: 82.70–91.3; specificity 99.7%, 95%CI: 99.4–99.9) and the national RDT algorithm (sensitivity 93.4%, 95%CI: 89.7–96.1%; specificity 100% (95%CI: 99.8–100%) had considerably lower sensitivity. Conclusions Self-testers in Zambia who used OraQuick® HIV Self-Test achieved reasonable clinical performance compared to the national RDT algorithm. However, sensitivity of the self-test was reduced compared to a laboratory reference standard, as was the national RDT algorithm. In-person demonstration, along with the written manufacturer instructions, was needed to obtain accurate results. Programmes introducing self-care diagnostics should pilot and optimise support materials to ensure they are appropriately adapted to context. HIV self-testing (dpeaa)DE-He213 HIV (dpeaa)DE-He213 Diagnostic tests (dpeaa)DE-He213 In vitro diagnostics (dpeaa)DE-He213 Self-care (dpeaa)DE-He213 Mwinga, Alwyn aut Kapaku, Kezia aut Sigande, Lucheka aut Gotsche, Caroline aut Taegtmeyer, Miriam aut Dacombe, Russell aut Maluzi, Kwitaka aut Kosloff, Barry aut Johnson, Cheryl aut Hatzold, Karin aut Corbett, Elizabeth L. aut Ayles, Helen aut Enthalten in BMC infectious diseases London : BioMed Central, 2001 22(2022), Suppl 1 vom: 25. Mai (DE-627)326645381 (DE-600)2041550-3 1471-2334 nnns volume:22 year:2022 number:Suppl 1 day:25 month:05 https://dx.doi.org/10.1186/s12879-022-07457-5 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 22 2022 Suppl 1 25 05 |
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Neuman, Melissa @@aut@@ Mwinga, Alwyn @@aut@@ Kapaku, Kezia @@aut@@ Sigande, Lucheka @@aut@@ Gotsche, Caroline @@aut@@ Taegtmeyer, Miriam @@aut@@ Dacombe, Russell @@aut@@ Maluzi, Kwitaka @@aut@@ Kosloff, Barry @@aut@@ Johnson, Cheryl @@aut@@ Hatzold, Karin @@aut@@ Corbett, Elizabeth L. @@aut@@ Ayles, Helen @@aut@@ |
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We assessed the clinical performance of the 2016 prototype OraQuick® HIV Self-Test in rural and urban communities in Zambia to assess the sensitivity and specificity of the test compared to the national HIV rapid diagnostic test (RDT) algorithm and a laboratory reference standard using 4th generation enzyme immunoassays and HIV RNA detection. Methods Participants were recruited from randomly selected rural and urban households and one urban health facility between May 2016 and June 2017. Participants received a brief demonstration of the self-test, and then self-tested without further assistance. The research team re-read the self-test, repeated the self-test, drew blood for the laboratory reference, and conducted RDTs following the national HIV testing algorithm (Determine™ HIV1/2 (Alere) confirmed using Unigold™ HIV1/2 (Trinity Biotech)). Selected participants (N = 85) were videotaped whilst conducting the testing to observe common errors. Results Initial piloting showed that written instructions alone were inadequate, and a demonstration of self-test use was required. Of 2,566 self-test users, 2,557 (99.6%) were able to interpret their result. Of participants who were videoed 75/84 (89.3%) completed all steps of the procedure correctly. Agreement between the user-read result and the researcher-read result was 99.1%. Compared to the RDT algorithm, user-conducted HIVST was 94.1% sensitive (95%CI: 90.2–96.7) and 99.7% specific (95%CI: 99.3–99.9). Compared to the laboratory reference, both user-conducted HIVST (sensitivity 87.5%, 95%CI: 82.70–91.3; specificity 99.7%, 95%CI: 99.4–99.9) and the national RDT algorithm (sensitivity 93.4%, 95%CI: 89.7–96.1%; specificity 100% (95%CI: 99.8–100%) had considerably lower sensitivity. Conclusions Self-testers in Zambia who used OraQuick® HIV Self-Test achieved reasonable clinical performance compared to the national RDT algorithm. 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Neuman, Melissa misc HIV self-testing misc HIV misc Diagnostic tests misc In vitro diagnostics misc Self-care Sensitivity and specificity of OraQuick® HIV self-test compared to a 4th generation laboratory reference standard algorithm in urban and rural Zambia |
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Sensitivity and specificity of OraQuick® HIV self-test compared to a 4th generation laboratory reference standard algorithm in urban and rural Zambia HIV self-testing (dpeaa)DE-He213 HIV (dpeaa)DE-He213 Diagnostic tests (dpeaa)DE-He213 In vitro diagnostics (dpeaa)DE-He213 Self-care (dpeaa)DE-He213 |
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Sensitivity and specificity of OraQuick® HIV self-test compared to a 4th generation laboratory reference standard algorithm in urban and rural Zambia |
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Neuman, Melissa Mwinga, Alwyn Kapaku, Kezia Sigande, Lucheka Gotsche, Caroline Taegtmeyer, Miriam Dacombe, Russell Maluzi, Kwitaka Kosloff, Barry Johnson, Cheryl Hatzold, Karin Corbett, Elizabeth L. Ayles, Helen |
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sensitivity and specificity of oraquick® hiv self-test compared to a 4th generation laboratory reference standard algorithm in urban and rural zambia |
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Sensitivity and specificity of OraQuick® HIV self-test compared to a 4th generation laboratory reference standard algorithm in urban and rural Zambia |
abstract |
Background HIV self-testing (HIVST) has the potential to increase coverage of HIV testing, but concerns exist about intended users’ ability to correctly perform and interpret tests, especially in poor communities with low literacy rates. We assessed the clinical performance of the 2016 prototype OraQuick® HIV Self-Test in rural and urban communities in Zambia to assess the sensitivity and specificity of the test compared to the national HIV rapid diagnostic test (RDT) algorithm and a laboratory reference standard using 4th generation enzyme immunoassays and HIV RNA detection. Methods Participants were recruited from randomly selected rural and urban households and one urban health facility between May 2016 and June 2017. Participants received a brief demonstration of the self-test, and then self-tested without further assistance. The research team re-read the self-test, repeated the self-test, drew blood for the laboratory reference, and conducted RDTs following the national HIV testing algorithm (Determine™ HIV1/2 (Alere) confirmed using Unigold™ HIV1/2 (Trinity Biotech)). Selected participants (N = 85) were videotaped whilst conducting the testing to observe common errors. Results Initial piloting showed that written instructions alone were inadequate, and a demonstration of self-test use was required. Of 2,566 self-test users, 2,557 (99.6%) were able to interpret their result. Of participants who were videoed 75/84 (89.3%) completed all steps of the procedure correctly. Agreement between the user-read result and the researcher-read result was 99.1%. Compared to the RDT algorithm, user-conducted HIVST was 94.1% sensitive (95%CI: 90.2–96.7) and 99.7% specific (95%CI: 99.3–99.9). Compared to the laboratory reference, both user-conducted HIVST (sensitivity 87.5%, 95%CI: 82.70–91.3; specificity 99.7%, 95%CI: 99.4–99.9) and the national RDT algorithm (sensitivity 93.4%, 95%CI: 89.7–96.1%; specificity 100% (95%CI: 99.8–100%) had considerably lower sensitivity. Conclusions Self-testers in Zambia who used OraQuick® HIV Self-Test achieved reasonable clinical performance compared to the national RDT algorithm. However, sensitivity of the self-test was reduced compared to a laboratory reference standard, as was the national RDT algorithm. In-person demonstration, along with the written manufacturer instructions, was needed to obtain accurate results. Programmes introducing self-care diagnostics should pilot and optimise support materials to ensure they are appropriately adapted to context. © The Author(s) 2022 |
abstractGer |
Background HIV self-testing (HIVST) has the potential to increase coverage of HIV testing, but concerns exist about intended users’ ability to correctly perform and interpret tests, especially in poor communities with low literacy rates. We assessed the clinical performance of the 2016 prototype OraQuick® HIV Self-Test in rural and urban communities in Zambia to assess the sensitivity and specificity of the test compared to the national HIV rapid diagnostic test (RDT) algorithm and a laboratory reference standard using 4th generation enzyme immunoassays and HIV RNA detection. Methods Participants were recruited from randomly selected rural and urban households and one urban health facility between May 2016 and June 2017. Participants received a brief demonstration of the self-test, and then self-tested without further assistance. The research team re-read the self-test, repeated the self-test, drew blood for the laboratory reference, and conducted RDTs following the national HIV testing algorithm (Determine™ HIV1/2 (Alere) confirmed using Unigold™ HIV1/2 (Trinity Biotech)). Selected participants (N = 85) were videotaped whilst conducting the testing to observe common errors. Results Initial piloting showed that written instructions alone were inadequate, and a demonstration of self-test use was required. Of 2,566 self-test users, 2,557 (99.6%) were able to interpret their result. Of participants who were videoed 75/84 (89.3%) completed all steps of the procedure correctly. Agreement between the user-read result and the researcher-read result was 99.1%. Compared to the RDT algorithm, user-conducted HIVST was 94.1% sensitive (95%CI: 90.2–96.7) and 99.7% specific (95%CI: 99.3–99.9). Compared to the laboratory reference, both user-conducted HIVST (sensitivity 87.5%, 95%CI: 82.70–91.3; specificity 99.7%, 95%CI: 99.4–99.9) and the national RDT algorithm (sensitivity 93.4%, 95%CI: 89.7–96.1%; specificity 100% (95%CI: 99.8–100%) had considerably lower sensitivity. Conclusions Self-testers in Zambia who used OraQuick® HIV Self-Test achieved reasonable clinical performance compared to the national RDT algorithm. However, sensitivity of the self-test was reduced compared to a laboratory reference standard, as was the national RDT algorithm. In-person demonstration, along with the written manufacturer instructions, was needed to obtain accurate results. Programmes introducing self-care diagnostics should pilot and optimise support materials to ensure they are appropriately adapted to context. © The Author(s) 2022 |
abstract_unstemmed |
Background HIV self-testing (HIVST) has the potential to increase coverage of HIV testing, but concerns exist about intended users’ ability to correctly perform and interpret tests, especially in poor communities with low literacy rates. We assessed the clinical performance of the 2016 prototype OraQuick® HIV Self-Test in rural and urban communities in Zambia to assess the sensitivity and specificity of the test compared to the national HIV rapid diagnostic test (RDT) algorithm and a laboratory reference standard using 4th generation enzyme immunoassays and HIV RNA detection. Methods Participants were recruited from randomly selected rural and urban households and one urban health facility between May 2016 and June 2017. Participants received a brief demonstration of the self-test, and then self-tested without further assistance. The research team re-read the self-test, repeated the self-test, drew blood for the laboratory reference, and conducted RDTs following the national HIV testing algorithm (Determine™ HIV1/2 (Alere) confirmed using Unigold™ HIV1/2 (Trinity Biotech)). Selected participants (N = 85) were videotaped whilst conducting the testing to observe common errors. Results Initial piloting showed that written instructions alone were inadequate, and a demonstration of self-test use was required. Of 2,566 self-test users, 2,557 (99.6%) were able to interpret their result. Of participants who were videoed 75/84 (89.3%) completed all steps of the procedure correctly. Agreement between the user-read result and the researcher-read result was 99.1%. Compared to the RDT algorithm, user-conducted HIVST was 94.1% sensitive (95%CI: 90.2–96.7) and 99.7% specific (95%CI: 99.3–99.9). Compared to the laboratory reference, both user-conducted HIVST (sensitivity 87.5%, 95%CI: 82.70–91.3; specificity 99.7%, 95%CI: 99.4–99.9) and the national RDT algorithm (sensitivity 93.4%, 95%CI: 89.7–96.1%; specificity 100% (95%CI: 99.8–100%) had considerably lower sensitivity. Conclusions Self-testers in Zambia who used OraQuick® HIV Self-Test achieved reasonable clinical performance compared to the national RDT algorithm. However, sensitivity of the self-test was reduced compared to a laboratory reference standard, as was the national RDT algorithm. In-person demonstration, along with the written manufacturer instructions, was needed to obtain accurate results. Programmes introducing self-care diagnostics should pilot and optimise support materials to ensure they are appropriately adapted to context. © The Author(s) 2022 |
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Sensitivity and specificity of OraQuick® HIV self-test compared to a 4th generation laboratory reference standard algorithm in urban and rural Zambia |
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Mwinga, Alwyn Kapaku, Kezia Sigande, Lucheka Gotsche, Caroline Taegtmeyer, Miriam Dacombe, Russell Maluzi, Kwitaka Kosloff, Barry Johnson, Cheryl Hatzold, Karin Corbett, Elizabeth L. Ayles, Helen |
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Mwinga, Alwyn Kapaku, Kezia Sigande, Lucheka Gotsche, Caroline Taegtmeyer, Miriam Dacombe, Russell Maluzi, Kwitaka Kosloff, Barry Johnson, Cheryl Hatzold, Karin Corbett, Elizabeth L. Ayles, Helen |
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We assessed the clinical performance of the 2016 prototype OraQuick® HIV Self-Test in rural and urban communities in Zambia to assess the sensitivity and specificity of the test compared to the national HIV rapid diagnostic test (RDT) algorithm and a laboratory reference standard using 4th generation enzyme immunoassays and HIV RNA detection. Methods Participants were recruited from randomly selected rural and urban households and one urban health facility between May 2016 and June 2017. Participants received a brief demonstration of the self-test, and then self-tested without further assistance. The research team re-read the self-test, repeated the self-test, drew blood for the laboratory reference, and conducted RDTs following the national HIV testing algorithm (Determine™ HIV1/2 (Alere) confirmed using Unigold™ HIV1/2 (Trinity Biotech)). Selected participants (N = 85) were videotaped whilst conducting the testing to observe common errors. Results Initial piloting showed that written instructions alone were inadequate, and a demonstration of self-test use was required. Of 2,566 self-test users, 2,557 (99.6%) were able to interpret their result. Of participants who were videoed 75/84 (89.3%) completed all steps of the procedure correctly. Agreement between the user-read result and the researcher-read result was 99.1%. Compared to the RDT algorithm, user-conducted HIVST was 94.1% sensitive (95%CI: 90.2–96.7) and 99.7% specific (95%CI: 99.3–99.9). Compared to the laboratory reference, both user-conducted HIVST (sensitivity 87.5%, 95%CI: 82.70–91.3; specificity 99.7%, 95%CI: 99.4–99.9) and the national RDT algorithm (sensitivity 93.4%, 95%CI: 89.7–96.1%; specificity 100% (95%CI: 99.8–100%) had considerably lower sensitivity. Conclusions Self-testers in Zambia who used OraQuick® HIV Self-Test achieved reasonable clinical performance compared to the national RDT algorithm. However, sensitivity of the self-test was reduced compared to a laboratory reference standard, as was the national RDT algorithm. In-person demonstration, along with the written manufacturer instructions, was needed to obtain accurate results. 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