TABLE 2.
Technical Profiles of Four HST Commercial Products Registered in the Thai Market by 2024a
| Product Profiles | Insti | OraQuick | I-CARE | CheckNOW |
|---|---|---|---|---|
| Specimen type | Fingertip blood | Oral fluid | Fingertip blood | Fingertip blood |
| Principle of test kit | Immuno Dot-Flow-through device |
Immuno-chromatography (2nd generation) |
Lateral flow immunoassay |
Immuno-chromatography (3rd generation) |
| Sensitivity as declared on the documentation (sensitivity required by MOPH), % | 99.50 (99.50) | 100 (99.00)b | 99.50 (99.50) | 100 (99.50) |
| Specificity as declared on the documentation (specificity required by MOPH), % | 100 (99.00) | 99.87 (98.00)b | 100 (99.00) | 99.90 (99.00) |
| FDA registration date | May 28, 2021 | July 20, 2021 | September 13, 2022 | October 25, 2023 |
| Retail market price, Baht (US$)c | 590–700 (17.10–20.30) | 350 (10.10) | 300 (8.70) | 90 (2.60) |
| E-bidding price by DDC, Baht (US$) | 200 (5.80) | 150 (4.3) | 135 (3.9) | 80 (2.3) |
| Distribution in the market | 334 pharmacies in 39 provinces and online channels | 252 pharmacies in 56 provinces and online channels | Online channels only | Service units registered with NHSO |
Abbreviations: DDC, Department of Disease Control; FDA, Food and Drug Administration; HST, HIV self-testing; MOPH, Ministry of Public Health; NHSO, National Health Security Office.
a Data as of May 28, 2024.
b Thailand Food and Drug Administration sets a slightly lower sensitivity and specificity for oral fluid test than blood test.
c Exchange rate as of May 28, 2024.