PONE_D_18_17456_ Oraquick data
Principal Investigator(s): View help for Principal Investigator(s) Tekalign Deressa, University of Gondar, Ethiopia & Ethiopian Public health Institute
Version: View help for Version V1
| Name | File Type | Size | Last Modified |
|---|---|---|---|
|
|
application/x-spss-sav | 53.2 KB | 01/09/2019 03:29:AM |
Project Citation:
Deressa, Tekalign. PONE_D_18_17456_ Oraquick data . Ann Arbor, MI: Inter-university Consortium for Political and Social Research [distributor], 2019-01-11. https://doi.org/10.3886/E108022V1
Project Description
Summary:
View help for Summary
Evaluation of diagnostic performance of non-invasive HIV self-testing kit using oral fluid in Addis Ababa, Ethiopia: A facility-based cross-sectional study Wudinesh Belete1, Tekalign Deressa1*, Altaye Feleke1, Takele Menna1, Tezera Moshago1, Saro Abdella1, Abebe Hebtesilassie1, Yimam Getaneh1, Minilik Demissie1, Yonas Zula2, Israel Lemma2, Girmachew Mamo2, Endale Workalemahu2, Tsigereda Kifle1, Ebba Abate1
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.
Funding Sources:
View help for Funding Sources
The authors received no specific fund for this work (N/A)
Methodology
Response Rate:
View help for Response Rate
100%
Sampling:
View help for Sampling
Health facilities for this study were selected purposively based on their HIV positive yields.
Study subjects were enrolled consecutively (see details in the Manuscript)
Study subjects were enrolled consecutively (see details in the Manuscript)
Data Source:
View help for Data Source
HIV infected population
Collection Mode(s):
View help for Collection Mode(s)
paper and pencil interview (PAPI)
Weights:
View help for Weights
two decimal places were used
Unit(s) of Observation:
View help for Unit(s) of Observation
diagnostic kits
Geographic Unit:
View help for Geographic Unit
Addis Ababa, Ethiopia
Related Publications
Published Versions
Report a Problem
Found a serious problem with the data, such as disclosure risk or copyrighted content? Let us know.
This material is distributed exactly as it arrived from the data depositor. ICPSR has not checked or processed this material. Users should consult the investigator(s) if further information is desired.