Beyond analytical proficiency: information continuity gaps in human papillomavirus testing laboratories within China’s national external quality assessment network
Guigao Lin, Kuo ZhangAbstract
Objectives
External quality assessment (EQA) emphasizes analytical proficiency, but actionable molecular testing also depends on extra-analytical processes that link results to unique patients and subsequent care. We assessed patient de-duplication and downstream-result retrievability in HPV testing laboratories, using EQA performance as an analytical-quality anchor, and explored these capabilities as candidate quality indicators for the total testing process.
Methods
A voluntary institution-level web survey was embedded in the 2026 National Center for Clinical Laboratories HPV16/18 EQA network and collected 2025 operational data. Survey records were linked to 2025 EQA results. The primary outcome was any laboratory access to downstream cytology, colposcopy, or histopathology information after an HPV-positive result. Associations were examined using prespecified Firth logistic regression, with ordinal and narrower-exposure sensitivity analyses.
Results
Among 957 unique invitation-frame laboratories, 111 valid responses were obtained; 109 matched the frame (response rate 11 %). Among 89 respondents with 2025 EQA records, 88 (99 %) had fully correct HPV16/18 results. In contrast, 65/111 (59 %) laboratories could retrieve any downstream information, 14/111 (13 %) reported near-complete access, and 41/111 (37 %) could fully de-duplicate repeated tests from the same woman. Clinical service integration was associated with downstream information availability (OR 4.01, 95 % CI 1.71–9.84; p=0.001); the association persisted when exposure was restricted to screening/clinical-reporting functions (OR 3.30, 95 % CI 1.40–8.20; p=0.006).
Conclusions
High analytical proficiency did not imply closure of the extra-analytical testing loop. Patient identity resolution and downstream-result retrievability merit further standardization and validation as candidate quality indicators for molecular diagnostics and EQA-linked quality improvement.