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. 2021 Aug 28;11(9):1567. doi: 10.3390/diagnostics11091567

Table 2.

Overall real-world performances of 7 RATs; note that only samples where results of RAT and qPCR differed were cell-culture tested; Ct-threshold for qPCR positivity is 40; values are presented as parameter estimate (95% confidence interval); MDSe/Sp = manufacturer-declared sensitivity/specificity; NPS–nasopharyngeal swab; ANS–anterior nasal swab; NPV/PPV–negative/positive predictive value; N–number of subjects.

Test Sample Type NPS ANS 1 ANS 2 Saliva 1 Saliva 2 Saliva 3 Saliva 4
MDSe/Sp >93/100 >98/>99 >95/>99 >95/>98 >92/>99 >89/>96 >98/>99
N of Patients 480 488 406 217 191 407 98
Uncorrected for cell culture Prevalence 32.30% 26.40% 42.40% 43.30% 41.90% 42.80% 29.0%
(28.1–36.7%) (22.60–30.60%) (37.5–47.3%) (36.6–50.2%) (34.8–49.2%) (37.9–47.7%) (20.0–38.6%)
Sensitivity 80.60% 46.50% 54.10% 25.50% 15.00% 32.80% 3.60%
(73.5–86.5%) (37.70–55.50%) (46.3–61.7%) (17.1–35.6%) (8.0–24.7%) (25.8–40.3%) (0.10–18.3%)
Specificity 98.50% 99.40% 97.40% 98.40% 89.20% 89.30% 97.10%
(96.4–99.5%) (98.00–99.90%) (94.5–99.1%) (94.2–99.8%) (81.9–94.3%) (84.6–92.9%) (90.1–99.7%)
PPV 96.20% 96.80% 93.90% 92.30% 50.00% 69.50% 33.30%
(91.3–98.7%) (88.80–99.60%) (87.3–97.7%) (74.9–99.1%) (29.1–70.9%) (58.4–79.2%) (0.80–90.60%)
NPV 91.4% 83.80% 74.30% 63.40% 59.30% 64.00% 71.60%
(88.0–94.1%) (80.00–87.20%) (69.0–79.1%) (56.1–70.2%) (51.4–66.8%) (58.5–69.2%) (61.40–80.40%)
N of cell culture tested samples (viable virus present/absent) 35 (11/24) 69 (37/32) 78 (28/40) 72 (42/30) 66 (39/27) 141 (81/60) 27 (16/11)
Corrected for cell culture Prevalence 28.50% 20.30% 34.00% 30.40% 33.00% 34.20% 19.0%
(24.5–32.8%) (16.80–24.10%) (29.4–38.8%) (24.4–37.0%) (26.4–40.1%) (29.6–39.0%) (12.0–28.6%)
Sensitivity 91.20% 60.60% 67.40% 36.40% 19.00% 41.00% 5.30%
(85.2–95.4%) (50.30–70.30%) (58.9–75.1%) (24.9–49.1%) (10.2–30.9%) (32.7–49.7%) (0.1–26.0%)
Specificity 98.50% 99.50% 97.80% 98.70% 90.60% 90.70% 97.50%
(96.6–99.5%) (98.20–99.90%) (95.2–99.2%) (95.3–99.8%) (84.2–95.1%) (86.5–93.9%) (91.2–99.7%)
PPV 96.20% 96.80% 93.90% 92.30% 50.00% 69.50% 33.30%
(91.3–98.7%) (88.80–99.60%) (87.3–97.7%) (74.9–99.1%) (29.1–70.9%) (58.4–79.2%) (0.8–90.6%)
NPV 96.60% 90.80% 85.30% 78.00% 69.50% 74.80% 81.1%
(94.1–98.2%) (87.70–93.40%) (80.9–89.1%) (71.5–83.7%) (61.9–76.3%) (69.7–79.4%) (71.7–88.4%)