Evaluation of diagnostic performance of non-invasive HIV self-testing kit using oral fluid in Addis Ababa, Ethiopia: A facility-based cross-sectional study
Human immunodeficiency virus (HIV) testing is critical for early linkage to treatment and care services. However, there is a substantial gap in HIV testing, particularly in resource limited settings due to low accessibility of HIV testing sites, inconvenient testing hours, and concerns about loss of...
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| Vydané v: | PloS one Ročník 14; číslo 1; s. e0210866 |
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| Hlavní autori: | , , , , , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | English |
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United States
Public Library of Science
25.01.2019
Public Library of Science (PLoS) |
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| ISSN: | 1932-6203, 1932-6203 |
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| Abstract | Human immunodeficiency virus (HIV) testing is critical for early linkage to treatment and care services. However, there is a substantial gap in HIV testing, particularly in resource limited settings due to low accessibility of HIV testing sites, inconvenient testing hours, and concerns about loss of confidentiality. Thus, adopting new strategies such as HIV self-testing (HIVST) could overcome these barriers and increases HIV testing uptake.
The aim of this study was to evaluate the diagnostic performance of non-invasive HIVST kit using oral fluid for HIV diagnosis. This study also aimed to assess the ability of clients in interpretation of OraQuick HIVST results.
Between December 2017 and February 2018, a total of 400 study participants were enrolled into the study to assess a diagnostic accuracy of Oral fluid-based HIVST kit (OraQuick) in 15 public health facilities in Addis Ababa, Ethiopia. Participants were provided with instructions and visual aids on how to perform HIVST and interpret results. They also underwent a blood-based rapid HIV antibody test as per the current national algorithm. The results of HIVST were interpreted independently by the participants and respective health care workers (HCWs). The sensitivity, specificity, positive predictive value (PPV), Negative predictive value (NPV) and inter-rater agreement of the test were computed.
Out of 200 participants who tested positive on the national algorithm testing, oral fluid-based self-testing was positive in 199 (99.5%), false negative in 1 (0.5%). Of 200 participants who tested negative on the national algorithm testing, self-testing was negative in 200 (100%). There were no false positive and invalid tests. The sensitivity and specificity of the OraQuick HIVST were 99.5% (95%CI: 97.26-99.99) and 100% (95%CI: 98.18-100.0), respectively. The overall agreement between the two tests was high (κ value = 0.995). The PPV and NPV of OraQuick test were 100% and 99.5% (95%CI: 96.59-99.93) respectively.
This study showed a high diagnostic performance of OraQuick HIV self-test and suggests that OraQuick HIVST kit has a potential to be used for HIV testing in Ethiopia along with the national algorithm. |
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| AbstractList | Background Human immunodeficiency virus (HIV) testing is critical for early linkage to treatment and care services. However, there is a substantial gap in HIV testing, particularly in resource limited settings due to low accessibility of HIV testing sites, inconvenient testing hours, and concerns about loss of confidentiality. Thus, adopting new strategies such as HIV self-testing (HIVST) could overcome these barriers and increases HIV testing uptake. Objective The aim of this study was to evaluate the diagnostic performance of non-invasive HIVST kit using oral fluid for HIV diagnosis. This study also aimed to assess the ability of clients in interpretation of OraQuick HIVST results. Method Between December 2017 and February 2018, a total of 400 study participants were enrolled into the study to assess a diagnostic accuracy of Oral fluid-based HIVST kit (OraQuick) in 15 public health facilities in Addis Ababa, Ethiopia. Participants were provided with instructions and visual aids on how to perform HIVST and interpret results. They also underwent a blood-based rapid HIV antibody test as per the current national algorithm. The results of HIVST were interpreted independently by the participants and respective health care workers (HCWs). The sensitivity, specificity, positive predictive value (PPV), Negative predictive value (NPV) and inter-rater agreement of the test were computed. Results Out of 200 participants who tested positive on the national algorithm testing, oral fluid-based self-testing was positive in 199 (99.5%), false negative in 1 (0.5%). Of 200 participants who tested negative on the national algorithm testing, self-testing was negative in 200 (100%). There were no false positive and invalid tests. The sensitivity and specificity of the OraQuick HIVST were 99.5% (95%CI: 97.26-99.99) and 100% (95%CI: 98.18-100.0), respectively. The overall agreement between the two tests was high ([kappa] value = 0.995). The PPV and NPV of OraQuick test were 100% and 99.5% (95%CI: 96.59-99.93) respectively. Conclusion This study showed a high diagnostic performance of OraQuick HIV self-test and suggests that OraQuick HIVST kit has a potential to be used for HIV testing in Ethiopia along with the national algorithm. Human immunodeficiency virus (HIV) testing is critical for early linkage to treatment and care services. However, there is a substantial gap in HIV testing, particularly in resource limited settings due to low accessibility of HIV testing sites, inconvenient testing hours, and concerns about loss of confidentiality. Thus, adopting new strategies such as HIV self-testing (HIVST) could overcome these barriers and increases HIV testing uptake. The aim of this study was to evaluate the diagnostic performance of non-invasive HIVST kit using oral fluid for HIV diagnosis. This study also aimed to assess the ability of clients in interpretation of OraQuick HIVST results. Between December 2017 and February 2018, a total of 400 study participants were enrolled into the study to assess a diagnostic accuracy of Oral fluid-based HIVST kit (OraQuick) in 15 public health facilities in Addis Ababa, Ethiopia. Participants were provided with instructions and visual aids on how to perform HIVST and interpret results. They also underwent a blood-based rapid HIV antibody test as per the current national algorithm. The results of HIVST were interpreted independently by the participants and respective health care workers (HCWs). The sensitivity, specificity, positive predictive value (PPV), Negative predictive value (NPV) and inter-rater agreement of the test were computed. Out of 200 participants who tested positive on the national algorithm testing, oral fluid-based self-testing was positive in 199 (99.5%), false negative in 1 (0.5%). Of 200 participants who tested negative on the national algorithm testing, self-testing was negative in 200 (100%). There were no false positive and invalid tests. The sensitivity and specificity of the OraQuick HIVST were 99.5% (95%CI: 97.26-99.99) and 100% (95%CI: 98.18-100.0), respectively. The overall agreement between the two tests was high (κ value = 0.995). The PPV and NPV of OraQuick test were 100% and 99.5% (95%CI: 96.59-99.93) respectively. This study showed a high diagnostic performance of OraQuick HIV self-test and suggests that OraQuick HIVST kit has a potential to be used for HIV testing in Ethiopia along with the national algorithm. Human immunodeficiency virus (HIV) testing is critical for early linkage to treatment and care services. However, there is a substantial gap in HIV testing, particularly in resource limited settings due to low accessibility of HIV testing sites, inconvenient testing hours, and concerns about loss of confidentiality. Thus, adopting new strategies such as HIV self-testing (HIVST) could overcome these barriers and increases HIV testing uptake. The aim of this study was to evaluate the diagnostic performance of non-invasive HIVST kit using oral fluid for HIV diagnosis. This study also aimed to assess the ability of clients in interpretation of OraQuick HIVST results. Between December 2017 and February 2018, a total of 400 study participants were enrolled into the study to assess a diagnostic accuracy of Oral fluid-based HIVST kit (OraQuick) in 15 public health facilities in Addis Ababa, Ethiopia. Participants were provided with instructions and visual aids on how to perform HIVST and interpret results. They also underwent a blood-based rapid HIV antibody test as per the current national algorithm. The results of HIVST were interpreted independently by the participants and respective health care workers (HCWs). The sensitivity, specificity, positive predictive value (PPV), Negative predictive value (NPV) and inter-rater agreement of the test were computed. Out of 200 participants who tested positive on the national algorithm testing, oral fluid-based self-testing was positive in 199 (99.5%), false negative in 1 (0.5%). Of 200 participants who tested negative on the national algorithm testing, self-testing was negative in 200 (100%). There were no false positive and invalid tests. The sensitivity and specificity of the OraQuick HIVST were 99.5% (95%CI: 97.26-99.99) and 100% (95%CI: 98.18-100.0), respectively. The overall agreement between the two tests was high ([kappa] value = 0.995). The PPV and NPV of OraQuick test were 100% and 99.5% (95%CI: 96.59-99.93) respectively. This study showed a high diagnostic performance of OraQuick HIV self-test and suggests that OraQuick HIVST kit has a potential to be used for HIV testing in Ethiopia along with the national algorithm. Human immunodeficiency virus (HIV) testing is critical for early linkage to treatment and care services. However, there is a substantial gap in HIV testing, particularly in resource limited settings due to low accessibility of HIV testing sites, inconvenient testing hours, and concerns about loss of confidentiality. Thus, adopting new strategies such as HIV self-testing (HIVST) could overcome these barriers and increases HIV testing uptake.BACKGROUNDHuman immunodeficiency virus (HIV) testing is critical for early linkage to treatment and care services. However, there is a substantial gap in HIV testing, particularly in resource limited settings due to low accessibility of HIV testing sites, inconvenient testing hours, and concerns about loss of confidentiality. Thus, adopting new strategies such as HIV self-testing (HIVST) could overcome these barriers and increases HIV testing uptake.The aim of this study was to evaluate the diagnostic performance of non-invasive HIVST kit using oral fluid for HIV diagnosis. This study also aimed to assess the ability of clients in interpretation of OraQuick HIVST results.OBJECTIVEThe aim of this study was to evaluate the diagnostic performance of non-invasive HIVST kit using oral fluid for HIV diagnosis. This study also aimed to assess the ability of clients in interpretation of OraQuick HIVST results.Between December 2017 and February 2018, a total of 400 study participants were enrolled into the study to assess a diagnostic accuracy of Oral fluid-based HIVST kit (OraQuick) in 15 public health facilities in Addis Ababa, Ethiopia. Participants were provided with instructions and visual aids on how to perform HIVST and interpret results. They also underwent a blood-based rapid HIV antibody test as per the current national algorithm. The results of HIVST were interpreted independently by the participants and respective health care workers (HCWs). The sensitivity, specificity, positive predictive value (PPV), Negative predictive value (NPV) and inter-rater agreement of the test were computed.METHODBetween December 2017 and February 2018, a total of 400 study participants were enrolled into the study to assess a diagnostic accuracy of Oral fluid-based HIVST kit (OraQuick) in 15 public health facilities in Addis Ababa, Ethiopia. Participants were provided with instructions and visual aids on how to perform HIVST and interpret results. They also underwent a blood-based rapid HIV antibody test as per the current national algorithm. The results of HIVST were interpreted independently by the participants and respective health care workers (HCWs). The sensitivity, specificity, positive predictive value (PPV), Negative predictive value (NPV) and inter-rater agreement of the test were computed.Out of 200 participants who tested positive on the national algorithm testing, oral fluid-based self-testing was positive in 199 (99.5%), false negative in 1 (0.5%). Of 200 participants who tested negative on the national algorithm testing, self-testing was negative in 200 (100%). There were no false positive and invalid tests. The sensitivity and specificity of the OraQuick HIVST were 99.5% (95%CI: 97.26-99.99) and 100% (95%CI: 98.18-100.0), respectively. The overall agreement between the two tests was high (κ value = 0.995). The PPV and NPV of OraQuick test were 100% and 99.5% (95%CI: 96.59-99.93) respectively.RESULTSOut of 200 participants who tested positive on the national algorithm testing, oral fluid-based self-testing was positive in 199 (99.5%), false negative in 1 (0.5%). Of 200 participants who tested negative on the national algorithm testing, self-testing was negative in 200 (100%). There were no false positive and invalid tests. The sensitivity and specificity of the OraQuick HIVST were 99.5% (95%CI: 97.26-99.99) and 100% (95%CI: 98.18-100.0), respectively. The overall agreement between the two tests was high (κ value = 0.995). The PPV and NPV of OraQuick test were 100% and 99.5% (95%CI: 96.59-99.93) respectively.This study showed a high diagnostic performance of OraQuick HIV self-test and suggests that OraQuick HIVST kit has a potential to be used for HIV testing in Ethiopia along with the national algorithm.CONCLUSIONThis study showed a high diagnostic performance of OraQuick HIV self-test and suggests that OraQuick HIVST kit has a potential to be used for HIV testing in Ethiopia along with the national algorithm. Background Human immunodeficiency virus (HIV) testing is critical for early linkage to treatment and care services. However, there is a substantial gap in HIV testing, particularly in resource limited settings due to low accessibility of HIV testing sites, inconvenient testing hours, and concerns about loss of confidentiality. Thus, adopting new strategies such as HIV self-testing (HIVST) could overcome these barriers and increases HIV testing uptake. Objective The aim of this study was to evaluate the diagnostic performance of non-invasive HIVST kit using oral fluid for HIV diagnosis. This study also aimed to assess the ability of clients in interpretation of OraQuick HIVST results. Method Between December 2017 and February 2018, a total of 400 study participants were enrolled into the study to assess a diagnostic accuracy of Oral fluid-based HIVST kit (OraQuick) in 15 public health facilities in Addis Ababa, Ethiopia. Participants were provided with instructions and visual aids on how to perform HIVST and interpret results. They also underwent a blood-based rapid HIV antibody test as per the current national algorithm. The results of HIVST were interpreted independently by the participants and respective health care workers (HCWs). The sensitivity, specificity, positive predictive value (PPV), Negative predictive value (NPV) and inter-rater agreement of the test were computed. Results Out of 200 participants who tested positive on the national algorithm testing, oral fluid-based self-testing was positive in 199 (99.5%), false negative in 1 (0.5%). Of 200 participants who tested negative on the national algorithm testing, self-testing was negative in 200 (100%). There were no false positive and invalid tests. The sensitivity and specificity of the OraQuick HIVST were 99.5% (95%CI: 97.26–99.99) and 100% (95%CI: 98.18–100.0), respectively. The overall agreement between the two tests was high (κ value = 0.995). The PPV and NPV of OraQuick test were 100% and 99.5% (95%CI: 96.59–99.93) respectively. Conclusion This study showed a high diagnostic performance of OraQuick HIV self-test and suggests that OraQuick HIVST kit has a potential to be used for HIV testing in Ethiopia along with the national algorithm. Background Human immunodeficiency virus (HIV) testing is critical for early linkage to treatment and care services. However, there is a substantial gap in HIV testing, particularly in resource limited settings due to low accessibility of HIV testing sites, inconvenient testing hours, and concerns about loss of confidentiality. Thus, adopting new strategies such as HIV self-testing (HIVST) could overcome these barriers and increases HIV testing uptake. Objective The aim of this study was to evaluate the diagnostic performance of non-invasive HIVST kit using oral fluid for HIV diagnosis. This study also aimed to assess the ability of clients in interpretation of OraQuick HIVST results. Method Between December 2017 and February 2018, a total of 400 study participants were enrolled into the study to assess a diagnostic accuracy of Oral fluid-based HIVST kit (OraQuick) in 15 public health facilities in Addis Ababa, Ethiopia. Participants were provided with instructions and visual aids on how to perform HIVST and interpret results. They also underwent a blood-based rapid HIV antibody test as per the current national algorithm. The results of HIVST were interpreted independently by the participants and respective health care workers (HCWs). The sensitivity, specificity, positive predictive value (PPV), Negative predictive value (NPV) and inter-rater agreement of the test were computed. Results Out of 200 participants who tested positive on the national algorithm testing, oral fluid-based self-testing was positive in 199 (99.5%), false negative in 1 (0.5%). Of 200 participants who tested negative on the national algorithm testing, self-testing was negative in 200 (100%). There were no false positive and invalid tests. The sensitivity and specificity of the OraQuick HIVST were 99.5% (95%CI: 97.26–99.99) and 100% (95%CI: 98.18–100.0), respectively. The overall agreement between the two tests was high (κ value = 0.995). The PPV and NPV of OraQuick test were 100% and 99.5% (95%CI: 96.59–99.93) respectively. Conclusion This study showed a high diagnostic performance of OraQuick HIV self-test and suggests that OraQuick HIVST kit has a potential to be used for HIV testing in Ethiopia along with the national algorithm. |
| Audience | Academic |
| Author | Belete, Wudinesh Menna, Takele Mamo, Girmachew Getaneh, Yimam Kifle, Tsigereda Feleke, Altaye Zula, Yonas Abdella, Saro Abate, Ebba Workalemahu, Endale Moshago, Tezera Lemma, Israel Deressa, Tekalign Hebtesilassie, Abebe Demissie, Minilik |
| AuthorAffiliation | Instituto Rene Rachou, BRAZIL 1 Ethiopian Public health institute, Addis Ababa, Ethiopia 2 Population service International/E, Addis Ababa, Ethiopia |
| AuthorAffiliation_xml | – name: 2 Population service International/E, Addis Ababa, Ethiopia – name: Instituto Rene Rachou, BRAZIL – name: 1 Ethiopian Public health institute, Addis Ababa, Ethiopia |
| Author_xml | – sequence: 1 givenname: Wudinesh surname: Belete fullname: Belete, Wudinesh – sequence: 2 givenname: Tekalign orcidid: 0000-0003-1159-5866 surname: Deressa fullname: Deressa, Tekalign – sequence: 3 givenname: Altaye surname: Feleke fullname: Feleke, Altaye – sequence: 4 givenname: Takele surname: Menna fullname: Menna, Takele – sequence: 5 givenname: Tezera surname: Moshago fullname: Moshago, Tezera – sequence: 6 givenname: Saro surname: Abdella fullname: Abdella, Saro – sequence: 7 givenname: Abebe surname: Hebtesilassie fullname: Hebtesilassie, Abebe – sequence: 8 givenname: Yimam surname: Getaneh fullname: Getaneh, Yimam – sequence: 9 givenname: Minilik surname: Demissie fullname: Demissie, Minilik – sequence: 10 givenname: Yonas surname: Zula fullname: Zula, Yonas – sequence: 11 givenname: Israel surname: Lemma fullname: Lemma, Israel – sequence: 12 givenname: Girmachew surname: Mamo fullname: Mamo, Girmachew – sequence: 13 givenname: Endale surname: Workalemahu fullname: Workalemahu, Endale – sequence: 14 givenname: Tsigereda surname: Kifle fullname: Kifle, Tsigereda – sequence: 15 givenname: Ebba surname: Abate fullname: Abate, Ebba |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/30682062$$D View this record in MEDLINE/PubMed |
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| Copyright | COPYRIGHT 2019 Public Library of Science 2019 Belete et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. 2019 Belete et al 2019 Belete et al |
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| DOI | 10.1371/journal.pone.0210866 |
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| DocumentTitleAlternate | Performance evaluation of HIV self-testing |
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| References | ref12 ref15 RP Walensky (ref27) 2006; 145 ref14 ref11 ref10 ref2 ref1 N Pant Pai (ref18) 2007; 2 ref16 OT Ng (ref25) 2012; 7 BM Branson (ref4) 2013; 63 AE Meiberg (ref9) 2008; 5 AT Choko (ref17) 2011; 8 RL Hamers (ref19) 2008; 48 SF Morin (ref8) 2006; 41 B Hensen (ref13) 2014; 28 ref23 ref26 ref21 D Zachary (ref24) 2012; 12 ref7 J Sophie (ref20) 2009; 23 N Pant Pai (ref22) 2007; 7 ref3 ref6 ref5 |
| References_xml | – volume: 2 start-page: e367 year: 2007 ident: ref18 article-title: Evaluation of diagnostic accuracy, feasibility and client preference for rapid oral fluid-based diagnosis of HIV infection in rural India publication-title: PLoS ONE doi: 10.1371/journal.pone.0000367 – ident: ref1 – ident: ref3 – ident: ref5 – ident: ref7 – volume: 41 start-page: 218 year: 2006 ident: ref8 article-title: Removing barriers to knowing HIV status same-day mobile HIV testing in Zimbabwe publication-title: JAIDS – volume: 23 start-page: 7 year: 2009 ident: ref20 article-title: Field Evaluation of Diagnostic Accuracy of an Oral Fluid Rapid Test for HIV, Tested at Point-of-Service Sites in Rural Zimbabwe publication-title: AIDS PATIENT CARE and STDs – volume: 145 start-page: 459 year: 2006 ident: ref27 article-title: Rapid HIV testing at home: does it solve a problem or create one? publication-title: Annals of Internal Medicine doi: 10.7326/0003-4819-145-6-200609190-00010 – volume: 63 start-page: S117 issue: Suppl 2 year: 2013 ident: ref4 article-title: Expanding HIV testing: back to the future publication-title: J Acquir Immune Defic Syndr doi: 10.1097/QAI.0b013e3182986f25 – volume: 8 issue: 10 year: 2011 ident: ref17 article-title: The uptake and accuracy of oral kits for HIV self-testing in high HIV prevalence setting: a cross-sectional feasibility study in Blantyre, Malawi publication-title: PLoS Medicine doi: 10.1371/journal.pmed.1001102 – volume: 28 start-page: 2133 year: 2014 ident: ref13 article-title: Systematic review of strategies to increase men’s HIV testing in sub-Saharan Africa publication-title: AIDS doi: 10.1097/QAD.0000000000000395 – volume: 12 start-page: 183 issue: 1 year: 2012 ident: ref24 article-title: Field comparison of OraQuick ADVANCE Rapid HIV-1/2 antibody test and two blood-based rapid HIV antibody tests in Zambia publication-title: BMC infect dis doi: 10.1186/1471-2334-12-183 – ident: ref11 – ident: ref15 – volume: 7 start-page: 325 year: 2007 ident: ref22 article-title: Oral fluid-based rapid HIV testing: Issues, challenges and research directions publication-title: Expert Rev Mol Diagn doi: 10.1586/14737159.7.4.325 – ident: ref2 – ident: ref6 – ident: ref21 – ident: ref23 – volume: 7 start-page: e45168 issue: 9 year: 2012 ident: ref25 article-title: Accuracy and User-Acceptability of HIV Self-Testing Using an Oral Fluid-Based HIV Rapid Test publication-title: PLoS ONE doi: 10.1371/journal.pone.0045168 – ident: ref26 – volume: 5 start-page: 49 issue: 2 year: 2008 ident: ref9 article-title: Fear of stigmatization as barrier to voluntary HIV Counselling and Testing in South Africa publication-title: East African J Public Health – ident: ref16 – ident: ref10 – ident: ref12 – ident: ref14 – volume: 48 start-page: 116 year: 2008 ident: ref19 article-title: Diagnostic accuracy of 2 oral fluid-based tests for HIV surveillance in Namibia publication-title: J. Acquir Immune Defic Syndr doi: 10.1097/QAI.0b013e31816bcdcf |
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