Establishing Quality Assurance for HIV-1 Rapid Test for Recent Infection in Thailand through the Utilization of Dried Tube Specimens
Abstract
:1. Introduction
2. Materials and Methods
2.1. HIV-1 Test Samples
2.2. Preparation of HIV Dried Tube Specimens (DTS) QC and EQA Panel
2.3. Homogeneity and Stability of HIV DTS QC and EQA Panel
2.4. Implementation of HIV DTS QC and EQA
2.5. Packaging and Shipping of HIV DTS QC and EQA Panel
2.6. Evaluating the Laboratory Performance
2.7. Statistical Analysis
3. Results
3.1. Characterization of DTS QC/EQA for HIV-1 RTRI
3.2. Homogeneity and Stability of HIV DTS QC/EQA for HIV-1 RTRI
3.3. QC HIV-1 RTRI Performance
3.4. EQA HIV-1 RTRI Performance
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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RTRI Panel | Sample Type | Anti-HIV Test Results | HIV-1 RTRI Results | ||||
---|---|---|---|---|---|---|---|
Elecsys HIV Combi PT | Alere HIV Combo | Asanté™ HIV-1 Rapid Recency® Assay | |||||
Interpretation * | Interpretation | C | V | LT/R | Interpretation | ||
Recent Sample (N = 3) | Liquid | Reactive | Reactive | + | + | − | Recent |
DTS | Reactive | Reactive | + | + | − | Recent | |
Long-term Sample (N = 3) | Liquid | Reactive | Reactive | + | + | + | Long-term |
DTS | Reactive | Reactive | + | + | + | Long-term | |
Negative (N = 3) | Liquid | Non-reactive | Non-reactive | + | − | − | Negative |
DTS | Non-reactive | Non-reactive | + | − | − | Negative |
Tube No. | HIV Negative Samples | HIV-1 Recent Samples | HIV-1 Long-Term Samples | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
C | V | LT/R | Interpretation | C | V | LT/R | Interpretation | C | V | LT/R | Interpretation | |
1 | + | − | − | Negative | + | + | − | Recent | + | + | + | Long-term |
2 | + | − | − | Negative | + | + | − | Recent | + | + | + | Long-term |
3 | + | − | − | Negative | + | + | − | Recent | + | + | + | Long-term |
4 | + | − | − | Negative | + | + | − | Recent | + | + | + | Long-term |
5 | + | − | − | Negative | + | + | − | Recent | + | + | + | Long-term |
6 | + | − | − | Negative | + | + | − | Recent | + | + | + | Long-term |
7 | + | − | − | Negative | + | + | − | Recent | + | + | + | Long-term |
8 | + | − | − | Negative | + | + | − | Recent | + | + | + | Long-term |
9 | + | − | − | Negative | + | + | − | Recent | + | + | + | Long-term |
10 | + | − | − | Negative | + | + | − | Recent | + | + | + | Long-term |
RTRI Panel | Temp | −20 °C | 2–8 °C | Room Temp | 37 °C | 45 °C |
---|---|---|---|---|---|---|
Negative | Week 2 | Negative | Negative | Negative | Negative | Negative |
Week 4 | Negative | Negative | Negative | Negative | Negative | |
Week 6 | Negative | Negative | Negative | Negative | Negative | |
Week 8 | Negative | Negative | Negative | Negative | Negative | |
Recent | Week 2 | Recent | Recent | Recent | Recent | Recent |
Week 4 | Recent | Recent | Recent | Recent | * Negative | |
Week 6 | Recent | Recent | Recent | Recent | * Negative | |
Week 8 | Recent | Recent | Recent | Recent | * Negative | |
Long-term | Week 2 | Long-term | Long-term | Long-term | Long-term | Long-term |
Week 4 | Long-term | Long-term | Long-term | Long-term | * Recent | |
Week 6 | Long-term | Long-term | Long-term | Long-term | * Recent | |
Week 8 | Long-term | Long-term | Long-term | * Recent | * Negative |
Health Regions | A-2022 (Apr 2022) | B-2022 (May 2022) | C-2022 (Jun 2022) | D-2022 (July 2022) | E-2022 (Aug 2022) | A-2023 (Apr 2023) |
---|---|---|---|---|---|---|
No. Lab Passed/No. Lab Total (%) | ||||||
Total | 46/48 (96) | 47/48 (98) | 46/48 (96) | 48/48 (100) | 46/46 (100) | 27/27 (100) |
Health region 1 | 3/3 (100) | 2/3 (67) | 3/3 (100) | 3/3 (100) | 3/3 (100) | 2/2 (100) |
Health region 2 | 2/2 (100) | 2/2 (100) | 2/2 (100) | 2/2 (100) | 1/1 (100) | NA * |
Health region 3 | 3/3 (100) | 3/3 (100) | 3/3 (100) | 3/3 (100) | 3/3 (100) | 3/3 (100) |
Health region 4 | 2/2 (100) | 2/2 (100) | 2/2 (100) | 2/2 (100) | 2/2 (100) | 1/1 (100) |
Health region 5 | 4/4 (100) | 4/4 (100) | 4/4 (100) | 4/4 (100) | 4/4 (100) | NA * |
Health region 6 | 1/1 (100) | 1/1 (100) | 1/1 (100) | 1/1 (100) | 1/1 (100) | 1/1 (100) |
Health region 7 | 2/3 (67) | 3/3 (100) | 2/3 (67) | 3/3 (100) | 2/2 (100) | 2/2 (100) |
Health region 8 | 1/1 (100) | 1/1 (100) | 1/1 (100) | 1/1 (100) | 1/1 (100) | 1/1 (100) |
Health region 9 | 2/2 (100) | 2/2 (100) | 2/2 (100) | 2/2 (100) | 2/2 (100) | NA * |
Health region 10 | 1/1 (100) | 1/1 (100) | 1/1 (100) | 1/1 (100) | 1/1 (100) | NA * |
Health region 11 | 7/7 (100) | 7/7 (100) | 7/7 (100) | 7/7 (100) | 7/7 (100) | 4/4 (100) |
Health region 12 | 4/4 (100) | 4/4 (100) | 4/4 (100) | 4/4 (100) | 4/4 (100) | 2/2 (100) |
Health region 13 | 14/15 (93) | 15/15 (100) | 14/15 (93) | 15/15 (100) | 15/15 (100) | 11/11 (100) |
RTRI Panel Sample | A-2022 (Apr 2022) | B-2022 (May 2022) | C-2022 (Jun 2022) | D-2022 (July 2022) | E-2022 (Aug 2022) | A-2023 (Apr 2023) | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
No. Lab Passed/No. Lab Total | % | No. Lab Passed/No. Lab Total | % | No. Lab Passed/No. Lab Total | % | No. Lab Passed/No. Lab Total | % | No. Lab Passed/No. Lab Total | % | No. Lab Passed/No. Lab Total | % | |
Negative | 46/48 | 96 | 48/48 | 100 | 47/48 | 98 | 48/48 | 100 | 46/46 | 100 | 27/27 | 100 |
Recent | 48/48 | 100 | 48/48 | 100 | 47/48 | 98 | 48/48 | 100 | 46/46 | 100 | 27/27 | 100 |
Long term | 48/48 | 100 | 47/48 | 98 | 47/48 | 98 | 48/48 | 100 | 46/46 | 100 | 27/27 | 100 |
Health Region | A-2022 (Apr 2022) | B-2022 (May 2022) | C-2022 (Jun 2022) | A-2023 (Jun 2023) | B-2023 (July 2023) |
---|---|---|---|---|---|
No. Lab Passed/No. Lab Total (%) | |||||
Total | 47/48 (98) | 47/48 (98) | 46/48 (96) | 27/27 (100) | 26/27 (96) |
Health region 1 | 3/3 (100) | 3/3 (100) | 3/3 (100) | 2/2 (100) | 2/2 (100) |
Health region 2 | 2/2 (100) | 2/2 (100) | 2/2 (100) | NA * | NA * |
Health region 3 | 3/3 (100) | 3/3 (100) | 3/3 (100) | 3/3 (100) | 3/3 (100) |
Health region 4 | 2/2 (100) | 2/2 (100) | 2/2 (100) | 1/1 (100) | 1/1 (100) |
Health region 5 | 4/4 (100) | 3/4 (75) | 4/4 (100) | NA * | NA * |
Health region 6 | 1/1 (100) | 1/1 (100) | 1/1 (100) | 1/1 (100) | 1/1 (100) |
Health region 7 | 3/3 (100) | 3/3 (100) | 3/3 (100) | 2/2 (100) | 2/2 (100) |
Health region 8 | 1/1 (100) | 1/1 (100) | 1/1 (100) | 1/1 (100) | 1/1 (100) |
Health region 9 | 2/2 (100) | 2/2 (100) | 2/2 (100) | NA * | NA * |
Health region 10 | 1/1 (100) | 1/1 (100) | 1/1 (100) | NA * | NA * |
Health region 11 | 7/7 (100) | 7/7 (100) | 7/7 (100) | 4/4 (100) | 3/4 (75) |
Health region 12 | 4/4 (100) | 4/4 (100) | 3/4 (75) | 2/2 (100) | 2/2 (100) |
Health region 13 | 14/15 (93) | 15/15 (100) | 14/15 (93) | 11/11 (100) | 11/11 (100) |
Sample ID | HIV-1 Test Samples | No. Lab Passed/ No. Lab Total | % | Sample ID | HIV-1 Test Samples | No. Lab Passed/ No. Lab Total | % | Sample ID | HIV-1 Test Samples | No. Lab Passed/ No. Lab Total | % |
---|---|---|---|---|---|---|---|---|---|---|---|
A-2022 (Apr 2022) | B-2022 (Jun 2022) | C-2022 (Aug 2022) | |||||||||
R651-1 | Recent | 48/48 | 100 | R652-1 | Negative | 48/48 | 100 | R653-1 | Long-term | 48/48 | 100 |
R651-2 | Long-term | 48/48 | 100 | R652-2 | Long-term | 48/48 | 100 | R653-2 | Recent | 48/48 | 100 |
R651-3 | Negative | 48/48 | 100 | R652-3 | Long-term | 47/48 ** | 98 | R653-3 | Negative | 47/48 ** | 100 |
R651-4 | Recent | 47/48 * | 98 | R652-4 | Recent | 47/48 ** | 98 | R653-4 | Recent | 47/48 * | 98 |
A-2023 (Jun 2023) | B-2023 (July 2023) | ||||||||||
R661-1 | Long-term | 27/27 | 100 | R662-1 | Recent | 27/27 | 100 | ||||
R661-2 | Negative | 27/27 | 100 | R662-2 | Long-term | 26/27 ** | 96 | ||||
R661-3 | Recent | 27/27 | 100 | R662-3 | Negative | 27/27 | 100 |
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Suparak, S.; Unpol, P.; Ngueanchanthong, K.; Chisholm, S.P.; Jomjunyoung, S.; Thanyacharern, W.; Smanthong, N.; Pinrod, P.; Srithanaviboonchai, K.; Yingyong, T.; et al. Establishing Quality Assurance for HIV-1 Rapid Test for Recent Infection in Thailand through the Utilization of Dried Tube Specimens. Diagnostics 2024, 14, 1220. https://doi.org/10.3390/diagnostics14121220
Suparak S, Unpol P, Ngueanchanthong K, Chisholm SP, Jomjunyoung S, Thanyacharern W, Smanthong N, Pinrod P, Srithanaviboonchai K, Yingyong T, et al. Establishing Quality Assurance for HIV-1 Rapid Test for Recent Infection in Thailand through the Utilization of Dried Tube Specimens. Diagnostics. 2024; 14(12):1220. https://doi.org/10.3390/diagnostics14121220
Chicago/Turabian StyleSuparak, Supaporn, Petai Unpol, Kanokwan Ngueanchanthong, Sirilada Pimpa Chisholm, Siriphailin Jomjunyoung, Wipawee Thanyacharern, Nitis Smanthong, Pojaporn Pinrod, Kriengkrai Srithanaviboonchai, Thitipong Yingyong, and et al. 2024. "Establishing Quality Assurance for HIV-1 Rapid Test for Recent Infection in Thailand through the Utilization of Dried Tube Specimens" Diagnostics 14, no. 12: 1220. https://doi.org/10.3390/diagnostics14121220