In Vitro Diagnostics Eligible for WHO Prequalification
⚠️ Important Update – Changes to WHO’s Prequalification of IVD Assessment Procedure (from 2026)
Starting in 2026, WHO will introduce a new prequalification assessment procedure. The performance evaluation will no longer be part of the prequalification assessment and will become a separate procedure.
The information on this webpage reflects these upcoming changes. If you have any questions, please email WHO’s Prequalification of IVDs team at diagnostics@who.int.
The criteria and principles used for deciding whether to accept an application for WHO’s prequalification assessment is described in the guidance document “Eligibility criteria for WHO’s prequalification assessment of in vitro diagnostics”. IVDs eligible for WHO’s prequalification are listed in the tables below. The tables are updated regularly as the scope changes.
List of IVDs eligible for WHO’s prequalification assessment
Table 1: IVDs that are eligible for WHO’s prequalification assessment and for which WHO’s performance evaluation is required
Last updated: 15 December 2025
Analyte/pathogen | Technology |
|---|---|
| HIV | Rapid diagnostic testsa |
| Enzyme immunoassays | |
| Nucleic acid tests (early infant diagnosis) | |
| Hepatitis C virus | Rapid diagnostic testsa |
| Enzyme immunoassays | |
| Nucleic acid tests | |
| Hepatitis B virus | Rapid diagnostic tests |
| Enzyme immunoassays | |
| Malaria | Rapid diagnostic tests |
| Treponema pallidum (Syphilis) | Rapid diagnostic tests |
| Mycobacterium tuberculosis complex | Qualitative nucleic acid tests |
| LF-LAM urinary tests |
a Including rapid diagnostic tests intended for self-testing
Table 2: IVDs that are eligible for WHO’s prequalification assessment and for which WHO’s performance evaluation is currently not required
Last updated: 15 December 2025
Analyte/pathogen | Technology |
|---|---|
| HIV | Flow cytometer for enumeration of lymphocyte subset including CD4+ T cells, or a technology that can be used at or near the patient (quantitative or semi-quantitative) |
| Nucleic acid tests for measuring viral loads | |
| Hepatitis B virus | Quantitative nucleic acid tests |
| Human papilloma virus | Nucleic acid tests (DNA or mRNA)1 |
| Glucose-6-phosphate dehydrogenase (G6PD) enzyme | Technologies/formats to be used at or near the patient (quantitative or semi-quantitative or qualitative) |
| SARS-CoV-2 | Rapid diagnostic tests |
| Qualitative nucleic acid tests | |
| Blood glucose | Point of care system |
| HbA1c | Point of care system |
| Haemoglobin | Point of care systems |
| Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) | Nucleic acid tests (NG, CT, TV), Rapid diagnostic tests (NG) and Rapid diagnostics tests (CT) |
1 HPV NAT assays WHO has adopted the fulfilment of Meijer’s criteria in independent evaluations as the independent performance evaluation for HPV nucleic acid tests used to inform WHO’s decision on prequalification link here