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Table 1 Comparison of the sensitivity and specificity for ≥CIN2 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 2 (%) (CI) (n)

Specificity for ≥ CIN 2 (%) (CI) (n)

Clinician Collected / AmpFire

95.74% (88.85–98.63) (90/94)

90.77% (90.00–91.49) (5399/5948)

Self-Collected / AmpFire

96.81% (90.29–99.17) (91/94)

89.81% (89.01–90.56) (5342/5948)

Clinician Collected / Cobas

92.55% (84.75–96.70) (87/94)

91.04% (90.28–91.75) (5415/5948)

Self-Collected / Cobas

95.74% (88.85–98.63) (90/94)

88.48% (87.64–89.28) (5263/5948)

Clinician Collected / SeqHPV

91.49% (83.44–95.99) (86/94)

91.27% (90.52–91.97) (5429/5948)

Self-collected / SeqHPV

94.68% (87.45–98.03) (89/94)

90.72% (89.95–90.15) (5396/5948)

Cytology

72.34% (62.00–80.83) (68/94)

96.45% (95.94–96.90%) (5737/5948)

  1. McNemar’s p-value for the comparison of the sensitivity of direct endocervical collected AmpFire to direct endocervical collected Cobas is 0.37 and direct collected SeqHPV is 0.22. McNemar’s p-value for the comparison of the sensitivity of self-collected AmpFire to self-collected Cobas is 1 and self-collected SeqHPV is 0.68. McNemar’s p-value for the comparison for the specificities of direct endocervical collected AmpFire to direct endocervical collected Cobas is 0.12 and direct endocervical collected SeqHPV is <0.05. McNemar’s p-value for the comparison for the specificities of self-collected AmpFire to self-collected Cobas and SeqHPV both are <0.05. The HPV tests details of the three CIN2+ missed on self-collected AmpFire are as follows: 1. 33 year female, positive only on direct endocervical collected Cobas with normal cytology; 2. 39 year female, positive on direct endocervical and self-collected Cobas and SeqHPV with LSIL cytology; 3. 54 year female, positive only on self-collected SeqHPV with normal cytology