Table 3.
Pooled sensitivity and specificity using Reitsma's random-effects model, pooled diagnostic OR, AUC, and heterogeneity for primary subgroup analysis
| Number of studies (sample size) | Pooled sensitivity (95% CI) | Pooled specificity (95% CI) | Pooled diagnostic OR (95% CI) | AUC | I2(τ2) | ||
|---|---|---|---|---|---|---|---|
| LAMP | |||||||
| Overall | 31 (3453) | 83·3% (76·9–88·2) | 96·3% (93·8–97·8) | 188·37 (84·10–421·91) | 0·963 | 0% (3·96) | |
| Specimen | |||||||
| Nasopharyngeal swabs | 10 (1004) | 87·7% (78·3–93·4) | 92·4% (85·6–96·2) | 107·46 (29·47–391·83) | 0·955 | 19% (3·43) | |
| Oropharyngeal or throat swabs | 11 (1046) | 87·6% (77·9–93·4) | 91·3% (84·9–95·1) | 99·10 (30·17–325·49) | 0·952 | 21% (3·09) | |
| Saliva | 5 (773) | 86·2% (75·5–92·6) | 89·4% (83·0–93·5) | 68·15 (22·631–205·25) | 0·939 | 0·3% (2·72) | |
| Sputum | 7 (513) | 81·7% (76·3–86·1) | 98·6% (96·1–99·5) | 397·60 (127·59–1238·96) | 0·949 | 0% (0·0) | |
| RNA extraction | |||||||
| With RNA extraction | 17 (2445) | 88·0% (82·1–92·2) | 95·1% (90·9–97·4) | 288·67 (88·63–940·17) | 0·961 | 4·14% (4·72) | |
| Without RNA extraction | 14 (1008) | 73·6% (62·4–82·5) | 97·0% (94·1–98·5) | 106·50 (37·60–301·69) | 0·962 | 0% (2·13) | |
| Primer–probe set | |||||||
| ORF1ab primer | 6 (1008) | 86·2% (60·8–96·2) | 98·1% (96·4–99·3) | 362·39 (33·76–3890·00) | 0·984 | 8% (7·14) | |
| N primer | 10 (1136) | 84·4% (72·9–91·6) | 97·5% (93·9–99·0) | 260·98 (115·11–591·70) | 0·975 | 0% (0·0) | |
| E primer | 2 (146)* | 81·6% (71·0–89·5) | 100% (94·9–100) | 300·35 (38·53–2341·37) | 0·901 | 0% (0·0) | |
| RNA extraction method | |||||||
| Magnetic beads | 5 (408) | 81·3% (53·7–94·3) | 97·2% (89·3–99·3) | 180·22 (56·55–574·39) | 0·973 | 0% (0·0) | |
| Silica spin column | 19 (1634) | 83·7% (77·8–88·2) | 95·1% (91·1–97·4) | 198·02 (71·74–546·61) | 0·943 | 0% (3·4) | |
| dPCR | |||||||
| Overall | 15 (783) | 94·1% (88·9–96·9) | 78·5% (57·4–90·8) | 77·47 (24·68–243·19) | 0·946 | 0·5% (2·79) | |
| Specimen | |||||||
| Pharyngeal swabs | 7 (459) | 95·0% (87·5–98·1) | 90·1% (60·3–98·2) | 237·354 (39·35–1431·75) | 0·958 | 7% (3·38) | |
| Saliva | 3 (152)* | 89·7% (75·8–97·1) | 77·0% (68·1–84·4) | 18·76 (3·46–101·62) | 0·865 | 0% (1·16) | |
| Sputum | 2 (98)* | 100% (93·4–100) | 88·6% (75·4–96·2) | 283·29 (32·304–2484·26) | 0·979 | 0% (0·0) | |
| Primer–probe set | |||||||
| ORF1ab primer | 11 (544) | 97·3% (93·8–98·8) | 80·9% (53·7–93·9) | 158·584 (39·77–632·42) | 0·964 | 0·8% (2·46) | |
| N primer | 15 (783) | 94·1% (88·9–96·9) | 78·5% (57·4–90·8) | 77·47 (24·68–243·19) | 0·946 | 0·5% (2·79) | |
| RNA extraction method | |||||||
| Silica spin column | 8 (536) | 92·3% (83·0–96·7) | 81·6% (52·9–94·6) | 76·52 (15·35–381·44) | 0·937 | 10% (3·6) | |
| Automatic | 4 (173) | 96·5% (86·7–99·2) | 91·0% (75·2–97·1) | 310·37 (59·85–1609·41) | 0·972 | 0% (0·0) | |
| qPCR | |||||||
| Overall | 25 (3667) | 92·7% (88·3–95·6) | 92·9% (87·2–96·2) | 231·27 (86·77–616·44) | 0·967 | 0% (4·60) | |
| Specimen | |||||||
| Pharyngeal swabs | 13 (2250) | 96·1% (91·5–98·3) | 94·7% (88·1–97·8) | 638·96 (215·32–1896·09) | 0·982 | 0% (2·07) | |
| Saliva | 10 (1175) | 86·3% (78·6–91·6) | 90·9% (79·3–96·3) | 88·02 (24·89–311·28) | 0·921 | 0% (3·07) | |
| RNA extraction | |||||||
| With RNA extraction | 19 (3230) | 93·7% (88·4–96·6) | 92·4% (85·3–96·3) | 262·47 (81·57–844·57) | 0·971 | 0% (5·63) | |
| Without RNA extraction | 6 (437) | 89·7% (81·9–94·3) | 94·3% (79·2–98·6) | 157·61 (28·96–857·70) | 0·940 | 16% (2·53) | |
| Primer–probe set | |||||||
| ORF1ab primer | 5 (1369) | 97·3% (87·4–99·5) | 88·8% (85·7–91·2) | 527·47 (44·33–6276·02) | 0·892 | 0% (6·16) | |
| N primer | 12 (899) | 92·9% (87·0–96·3) | 91·3% (79·9–96·5) | 192·23 (83·16–444·36) | 0·961 | 4% (0·53) | |
| E primer | 11 (2442) | 92·3% (83·3–96·6) | 94·1% (85·5–97·7) | 208·13 (40·84–1060·61) | 0·971 | 8% (6·3) | |
| RNA extraction method | |||||||
| Magnetic beads | 7 (1170) | 92·9% (86·8–96·3) | 97·0% (88·4–99·3) | 462·91 (83·03–2580·88) | 0·968 | 25% (3·76) | |
| Silica spin column | 10 (1805) | 93·4% (82·9–97·6) | 84·0% (69·4–92·4) | 96·50 (21·89–425·37) | 0·948 | 6% (4·52) | |
| Automatic | 2 (224)* | 96·7% (88·5–99·6) | 91·5% (86·1–95·3) | 350·48 (42·61–2882·13) | 0·961 | 0% (0·0) | |
Data are n (N); sensitivity, specificity, or OR (95% CI); AUC; or I2 (τ2). Summary of subgroup analyses for LAMP, dPCR, and qPCR assays based on the number of true false-positive and false-negative cases reported in the 71 experiments. All dPCR assays required RNA extraction. OR=odds ratio. AUC=area under the curve. LAMP=loop-mediated isothermal amplification. ORF1ab=open reading frame 1 ab. N=nucleocapsid. E=envelope. dPCR=digital PCR. qPCR=quantitative PCR.
*
A univariate random-effects model was used to estimate sensitivities and specificities for subgroups with less than four included studies, as bivariate models do not converge when the sample size is small.