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Table 2 Comparison of the sensitivity and specificity for ≥CIN3 of physician-collected specimens (endocervical), and vaginal self-collected assayed for HR-HPV by AmpFire, Cobas, SeqHPV (95% CIs and the actual patient numbers are in parentheses)

From: Evaluation of an isothermal amplification HPV detection assay for primary cervical cancer screening

Specimen/High-Risk HPV Test

Sensitivity for ≥ CIN 3 (%) (CI) (n)

Specificity for ≥ CIN 3 (%) (CI)(n)

Clinician Collected / AmpFire

100% (88.29–100) (37/37)

89.98% (89.18–90.72) (5403/6005)

Self-Collected / AmpFire

100% (88.29–100) (37/37)

89.01% (88.18–89.78) (5345/6005)

Clinician Collected / Cobas

100% (88.29–100) (37/37)

90.29% (89.51–91.02) (5393/6005)

Self-Collected / Cobas

97.30% (84.19–99.86) (36/37)

87.70% (86.83–88.51) (5266/6005)

Clinician Collected / SeqHPV

100% (88.29–100) (37/37)

90.54% (89.77–91.26) (5393/6005)

Self-collected / SeqHPV

100% (88.29–100) (37/37)

89.94% (89.15–90.69) (5393/6005)

Cytology

100% (88.29–100) (37/37)

95.97% (95.43–96.45%) (5763/6005)

  1. Using McNemar’s for the comparison of the sensitivity of direct endocervical collected AmpFire (100.0%) to direct endocervical collected Cobas (100.0%) and SeqHPV (100.0%) both are p = 1.0; the sensitivity of self-collected AmpFire (100.0%) to self-collected Cobas (97.3%) and SeqHPV (100.0%) both are also p = 1.0. Using McNemar’s for the comparison of the specificities of direct endocervical collected AmpFire (90.0%) to direct endocervical collected Cobas (90.3%) is p = 0.09 and direct endocervical collected SeqHPV (90.5%) is p = 0.007; the comparison for the specificities of self-collected AmpFire (89.0%) to self-collected Cobas (87.7%) and SeqHPV (89.9%) both are p = <0.001