ArticleFrontiers in public health2026
Evaluating a rapid fit-testing method for N95 respirators in Chinese healthcare workers: a paired crossover simulation and diagnostic agreement study.
Article in Frontiers in public health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Not yet cited in PubMed.
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Abstract
Background: China lacks standardized rapid fit-testing protocols for N95 respirators. This exploratory study assessed the feasibility between the OSHA 2.5-min quantitative fit-testing protocol and the 6-min Chinese reference protocol among Chinese healthcare workers, also assessing mask seal degradation during chest compressions. Methods: A total of 54 nurses and physicians were recruited for this paired crossover simulation and diagnostic agreement study. Participants underwent quantitative fit testing using two N95 respirator models: D918 (a foldable respirator) and D920 (a cup-type respirator). Fit-test outcomes obtained using the 2.5-min protocol were compared with those obtained using the 6-min reference protocol. Paired pass results were analyzed using McNemar's test, and agreement was assessed using Cohen's kappa with 95% confidence intervals. Diagnostic indices, including sensitivity, specificity, positive predictive value, negative predictive value, and likelihood ratios, were calculated from raw 2 × 2 contingency tables. Seal integrity during simulated chest compressions was also evaluated. Results: Using the 6-min protocol as the reference, the D918 respirator showed pass rates of 75.93% [95%CI, 0.63 to 0.85] for the 2.5-min protocol and 81.48% [95%CI, 0.69 to 0.90] for the 6-min protocol. The corresponding sensitivity, specificity, PPV, PLR, and NLR were 97.56% [95%CI, 0.85 to 1.00], 69.23% [95%CI, 0.39 to 0.90], and 90.9% [95%CI, 0.77 to 0.97], 3.17 [95%CI, 1.40 to 7.18] and 0.03 [95%CI, 0.00 to 0.26], respectively. For the D920 respirator, pass rates were 92.59% [95%CI, 0.82 to 0.97] and 94.44% [95%CI, 0.85 to 0.99] for the 2.5-min and 6-min protocols, respectively, with sensitivity, specificity, PPV, PLR and NLR of 100% [95%CI, 0.91 to 1.00], 75% [95%CI, 0.22 to 0.99], 94.4% [95%CI, 0.84 to 0.99], 4.00 [95%CI, 0.73 to 21.84] and 0.02 [95%CI, 0 to not estimable]. During CC, baseline seal integrity was achieved in 98.15% of participants. The D918 showed clinically significant leakage during (44.44%) and post-compression (29.63%), contrasting with D920's maintained performance ( Conclusion: In this exploratory paired simulation study, the OSHA 2.5-min protocol showed preliminary agreement with the 6-min Chinese reference protocol for quantitative N95 respirator fit testing among Chinese healthcare workers, particularly for the D920 respirator. However, the study does not establish formal equivalence or non-inferiority. Larger multicenter studies with prespecified non-inferiority margins are needed before the rapid protocol can be recommended as a replacement for the standard 6-min protocol.
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