Four point-of-care HR-HPV assays (PathoDetect-HPV-14, HPV-Q, Truenat-HR-HPV-Plus [8-type], and PathoDetect-HPV-7 [7-type]) were evaluated for clinical accuracy and reproducibility in cervical cancer screening using 1,159 cervical samples from the ESTAMPA study (Argentina and Costa Rica), compared against reference assays (Cobas-4800 and Allplex-HPV-HR) via the VALGENT framework.
Truenat-HR-HPV-Plus met IARC validation criteria with 80.4% sensitivity (95% CI: 71.1–87.8) and 91.5% specificity (95% CI: 89.5–93.2) for CIN2+, non-inferior to Allplex-HPV-HR-8, and repeatability of 93.3% (κ=0.79); PathoDetect-HPV-7 showed lower sensitivity (68.1%); HPV-Q and PathoDetect-HPV-14 did not meet validation criteria.
Samples were derived from a single multi-country study (Argentina and Costa Rica), which may limit generalizability to other low-resource settings; the CIN2+ case count was modest (n=97, including only 6 cancers), which constrains precision of estimates at the cancer endpoint.
Truenat-HR-HPV-Plus (8-type) is a validated point-of-care option for cervical cancer screening in low-resource settings, offering higher specificity than 14-valent assays and potentially reducing unnecessary referrals. PathoDetect-HPV-7 and the two 14-type assays should not be used as primary screening tools until further validation is completed.
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