Note that the data from the current clinical evaluation has been included in the analysis.
(A) The sensitivity of ID NOW as compared with the reference standard, and the overall sensitivity was estimated to be 82% with a lower 95% confidence bound at 67% and an upper bound of 91%. (B) The …
For patients with multiple tests, only the first positive test is included. In (C), data for each group of patients has been normalized so that the sum of all bins is 100, allowing better comparison …
A total of two swabs was collected on each patient, with patients having an even birth year number the right nares were collected first followed by a second swipe in the left nares and then for ID …
Hologic result | ||||
---|---|---|---|---|
NEG | POS | Total | ||
ID NOW result | NEG | 942 | 2 | 944 |
POS | 0 | 21 | 21 | |
Invalid | 9 | 0 | 9 | |
Total | 951 | 23 | 974 | |
Negative agreement | 100.00% (82–100%) | |||
Positive agreement | 91.30% (70–98%) |
Study | Site | ID NOW sampling device | Residual sample tested? | ID NOW sample dry? | Timing of ID NOW test | Patient characteristics | Patient selection bias? | Index test bias? | Flow and timing bias | N (positive rate) | RT–PCR | Abbott ID now |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Positive/CP % (95% CI) | Positive/CP % (95% CI) | |||||||||||
Lephart et al., 2020 | AN | Foam | No | Yes | Up to 24 at 4°C | Convenience Hosp. and ED | Unclear | Unclear | Unclear | 88 (31%) | 27/27 91% (85–100%) | 12/27 44% (26–64%) |
Basu et al., 2020 | AN | Foam | No | Yes | Up to 24 at 4°C | Convenience Hosp. and ED | Unclear | Unclear | Unclear | 101 (31%) | 31/32 97% (82–100%) | 18/32 56% (38–73%) |
Cradic et al., 2020 | AN | Foam | No | Yes | Unclear | Symptomatic | Low | Unclear | Unclear | 182 (7.1%) | 13/13 100% (72–100%) | 12/13 92% (62–100%) |
Harrington et al., 2020 | AN | Foam | No | Yes | Unclear | Clinic, ED | Low | Unclear | Unclear | 524 (36%) | 186/188 99% (96–100%) | 141/188 75% (68–81%) |
Jin et al., 2020† | U | U | No | Yes | Unclear | U | Unclear | Unclear | Unclear | 52 (12%) | 6/6 100% (52–100%) | 4/6 67% (24–94%) |
Mitchell and George, 2020 | NP | U | Yes | No | Unclear | U | High | High | Unclear | 61 (75%) | 46/46 100% (90–100%) | 33/46 72% (56–84%) |
Moore et al., 2020 | NP | U | No | No | Unclear | Symptomatic | High | Unclear | Unclear | 200 (64%) | 127/127 100% (96–100%) | 94/127 74% (65–81%) |
Rhoads et al., 2020 | AN, NP | U | Yes | No | Unclear | PCR+ | High | Unclear | Unclear | 96 (100%) | 96/96 100% (95–100%) | 90/96 94% (86–97%) |
Smithgall et al., 2020 | NP | U | Yes | No | Up to 48 hr at 4°C | Selected | High | Unclear | Unclear | 113 (80%) | 89/90 99% (94–100%) | 65/88 74% (64–82%) |
Thwe and Ren, 2020 | NP | U | No | Yes | ~2 hr | Symptomatic Hosp. and ED | High | Unclear | Unclear | 129 (7.7%) | 15/15 100% (75–100%) | 8/15 53% (27–78%) |
Zhen et al., 2020b | NP | Many | Yes (most) | No | Up to 72 hr at 4°C | Symptomatic | Unclear | Unclear | Unclear | 107 (54%) | 57/58 98% (90–100%) | 50/57 88 (76–95) |
Comer and Fisk, 2020 | AN | Foam | No | Yes | 15 m | U | High | Low | Low | 117 (0.9%) | 1/1 100% (5–100%) | 0/1 0% (0–95%) |
Ghofrani et al., 2020 | AN | Many | No | Yes | Unclear | Mostly symptomatic convenience | High | Unclear | High | 113 (16%) | 17/18 94% (71–99%) | 17/18 94% (71–99%) |
SoRelle et al., 2020‡ | S | Tube | No | No | Unclear | U | Unclear | Low | Low | 59 (39%) | 23/23 100% (82–100%) | 18/23 78% (56–92%) |
Tu (this study) | AN | Foam | No | Yes | 15 m | symptomatic and asymptomatic | Low | Low | Low | 974 (2.4%) | 23/23 100% (82–100%) | 21/23 91% (70–98%) |
*Likely <2 hr in some cases, more than a single type of sampling device was used. When a dry ID NOW foam swab was used as a part of this study, both the table above and the results reflect the use of that device, which is consistent with the current ID NOW package insert. Comparisons based upon use of other transport media are only shown when no data was presented for use of dry swabs.
†Table shows only the comparison between ID NOW and Cobas using dry swabs.
‡Table shows comparison of saliva tested on ID NOW vs saliva tested using Cepheid Xpert Xpress SARS-CoV-2.
Abbreviations in table: AN = anterior nares; OP = oropharynx; NP = nasopharynx; S = saliva; U = unknown.
Data are only presented from papers in which it was possible to construct a composite ‘gold standard’ in which a positive result on any platform contributed to create a ‘composite positive (CP)’. Specificity was assumed to be 100% for all platforms/tests. This differs from the method presented in some of the papers incorporated into this table.
Reagent type (species) or resource | Designation | Source or reference | Identifiers | Additional information |
---|---|---|---|---|
Commercial assay, kit | ID NOW SARS-CoV-2 reagents | Abbott | Cat. # 190–000 for COVID reagents Cat. # 190–080 for COVID controls | https://www.fda.gov/media/136525/download |
Commercial assay, kit | SARS-CoV-2 reagents | Hologic | Cat. # PRD-06420 for the COVID reagents and Cat. # 303014 for the assay fluids reagents | https://www.hologic.com/sites/default/files/2020-09/AW-21159-001_004_01.pdf |
ID NOW | |||
---|---|---|---|
Positive | Negative | ||
Cepheid XpertXpress | Positive | 12 | 15 |
Negative | 0 | 60 |
ID NOW | |||
---|---|---|---|
Positive | Negative | ||
Cepheid Xpert Xpress | Positive | 17 | 14 |
Negative | 1 | 69 |
ID NOW | |||
---|---|---|---|
Positive | Negative | ||
Diasorin Simplexa | Positive | 12 | 1 |
Negative | 0 | 169 |
ID NOW | |||
---|---|---|---|
Positive | Negative | ||
Abbott m2000 | Positive | 139 | 47 |
Negative | 2 | 336 |
ID NOW | |||
---|---|---|---|
Positive | Negative | ||
Roche COBAS | Positive | 4 | 2 |
Negative | 0 | 46 |
ID NOW | |||
---|---|---|---|
Positive | Negative | ||
RT–PCR – either CDC or New York EUA | Positive | 33 | 13 |
Negative | 0 | 15 |
ID NOW | |||
---|---|---|---|
Positive | Negative | ||
Abbott m2000 | Positive | 94 | 31 |
Negative | 0 | 73 |
ID NOW | |||
---|---|---|---|
Positive | Negative | ||
Diasorin Simplexa | Positive | 90 | 6 |
Negative | 0 | 0 |
ID NOW | |||
---|---|---|---|
Positive | Negative | ||
Roche COBAS | Positive | 65 | 23 |
Negative | 0 | 25 |
ID NOW | |||
---|---|---|---|
Positive | Negative | ||
RT–PCR | Positive | 8 | 7 |
Negative | 0 | 167 |
ID NOW | |||
---|---|---|---|
Positive | Negative | ||
Hologic Panther Fusion | Positive | 50 | 7 |
Negative | 0 | 50 |
ID NOW | |||
---|---|---|---|
Positive | Negative | ||
Becton Dickinson BD MAX | Positive | 0 | 1 |
Negative | 0 | 116 |
ID NOW | |||
---|---|---|---|
Positive | Negative | ||
RT–PCR | Positive | 16 | 1 |
Negative | 1 | 95 |
ID NOW | |||
---|---|---|---|
Positive | Negative | ||
Cepheid Xpert Xpress | Positive | 23 | 0 |
Negative | 0 | 35 |