| Study |
Study design Inclusion criteria |
Setting Country (Recruitment dates) |
Participant characteristics | Reference standard | Reference samples and timing |
Missing data Uninterpretable results Indeterminate results |
| Antigen tests | ||||||
|
Diao 2020 (Preprint) 239 samples (208 cases) for NP swab 20 samples (19 cases ) for urine |
Single group Samples from cases of suspected SARS‐CoV‐2 infection |
Not stated China (Not stated) |
Not stated High viral load (≤ 30 Ct): 56, 27% (reported for 208 samples) |
RT‐PCR (Daan Gene kit) Threshold < 40 Ct; threshold < 30 Ct also investigated Target: ORF1ab and N gene |
As for index test; NP swab Timing of reference: not stated Interval from/to index test: done in parallel |
Not reported Not reported Reference: "indeterminate" category introduced into the reference standard for values between 30 and 40 Index: not reported |
|
Lambert‐Niclot 2020 (Accepted manuscript) 138 samples (94 cases) |
Single group Samples submitted for RT‐PCR testing |
Not stated France (1‐15 April 2020) |
Not stated High viral load (≤ 25 Ct): 45, 48% (reported for 94 samples) |
RT‐PCR (different kits used) Target: E gene |
As for index test; NP swab Timing of reference: within a few hours after collection Interval from/to index test: same sample, both tests conducted within a few hours |
4 samples in cobas VTM gave invalid results so all samples in cobas medium were excluded Same as above Reference: none reported Index: control lines "barely visible" for 9 positive and 8 negative tests |
|
Mertens 2020 (Preprint) 328 samples (132 cases) |
Single group Samples from cases of suspected SARS‐CoV‐2 infection |
Not stated (university laboratory) Belgium (19‐30 March 2020) |
Not reported High viral load (≤ 25 Ct): 88, 67% (reported for 132 samples) |
qRT‐PCR (4 different kits used) Target:
|
As for index test; respiratory specimens (322 NP swabs, 4 NP aspirate and 2 BAL) Timing of reference: analysed at time of collection Interval from/to index test: same samples used; "some delay" between PCR and antigen testing |
No None reported Reference: none reported Index: weak T lines considered positive |
|
Porte 2020 (Preprint) 127 samples (82 cases) |
Two groups; deliberate sampling of PCR‐positive and negative cases 2:1 Samples from cohort of suspected COVID‐19 cases (n = 1453); patients with respiratory symptoms and/or fever and an epidemiological risk factor for SARS‐CoV‐2 infection (travel or contact with case) |
Outpatients at private hospital emergency room Chile (16‐21 March 2020) |
Cough 94 (74.6%);
Fever 77 (61.1%);
Median duration of symptoms 2 days (IQR 1–4; range 0‐12);
68 male (53.5%);
median age 38 years (IQR 29.5–44; range 1–91) High viral load (≤ 25 Ct): 52, 74% (reported for 70 samples) |
RT‐PCR (COVID‐19 Genesig Real‐Time PCR assay (Primer Design Ltd., Chander's Ford, UK)) Threshold ≤ 40 Ct Target: not stated |
As for index test; OP and NP swabs Timing of reference: median 2 days post‐symptom onset (IQR 1‐4; range 0‐12) Interval from/to index test: same sample used; within 48 hours |
No Not reported Reference: patients Index: not reported |
|
Weitzel 2020 [A] (Preprint) 111 samples (80 cases) |
Two groups; deliberate sampling of PCR‐positive and negative cases 2:1 Samples from patients with respiratory symptoms and/or fever attending a private hospital ED |
ED (private hospital) Chile (16‐26 March 2020) |
Respiratory symptoms and/or fever 50 male (45%); median age 40 years High viral load (≤ 25 Ct): 54, 68% (reported for 80 samples) |
RT‐PCR (COVID‐19 Genesig Real‐Time PCR assay (Primerdesign Ltd., Chander's Ford, UK)) Threshold ≤ 40Ct Target: RdRp gene |
As for index test; NOP swabs Timing of reference: as for index test; median 2 days (IQR 1‐5) Interval from/to index test: same samples; index tests conducted after frozen storage |
2 invalid excluded 2 invalid results in 2 tests due to insufficient liquid migration Reference: none reported Index: visual interpretation of the Savant assay (using manufacturer‐supplied UV torch) was reportedly difficult under daylight conditions; manufacturer's fluorescence reader not available in Chile |
| Rapid molecular tests | ||||||
|
Assennato 2020 (Preprint) 172 samples (88 cases; 91 after retesting) |
Single group Samples from symptomatic individuals with suspected COVID‐19 sent for routine laboratory diagnosis |
Not stated; supplied by PHE UK (Not stated) |
Symptomatic | RT‐PCR (2 different kits used);
Target:
|
As for index; combined nose and throat swab in VTM Timing of reference: not stated Interval from/to index test: not stated; likely reference carried out for routine diagnostic testing |
None reported None reported Reference: all samples tested with second RT‐PCR, including 3 FP and 1 FN (see Table 4) assays Index: 3 FP and 1 FN result retested using SAMBA‐II (see Table 4) |
|
Broder 2020 (Accepted manuscript) 35 samples (35 cases) |
Single group (cases) Samples positive on RT‐PCR with lower range of viral load (E target Ct ≥ 30) |
Not stated (laboratory) USA (Not stated) |
All lower viral load | RT‐PCR (Roche cobas 6800 SARS‐CoV‐2 assay) Target: E gene (unclear if other genetic targets as well) |
As for index test; NP swab Timing of reference: not stated (presumably on presentation) Interval from/to index test: same samples; index test within 3 days of reference |
None reported None reported Reference: samples positive on reference were tested by in‐house assay using modified CDC protocol Index: none reported |
|
Harrington 2020 (Accepted manuscript) 524 samples (186 cases) |
Single group Symptomatic patients, diagnostic criteria for COVID‐19 |
EDs (n = 3) or urgent care centres (n = 2) USA (Not stated) |
Not stated | RT‐PCR (Abbott RealTime SARS‐CoV‐2 (ACOV) assay performed on the Abbott m2000 system (Abbott Molecular Inc. Des Plaines, IL) Threshold: not stated Target: not stated |
NP swabs (paired) Timing of reference: not reported Interval from/to index test: simultaneous swab collection |
None reported None reported Reference: 2 initial FPs had repeat sampling (see Table 4) Index: none reported |
|
Hogan 2020 (Preprint) 100 samples (50 cases) |
Single group Samples from adult patients from 1 hospital and paediatric and adult samples from surrounding hospitals |
Not stated (clinical virology laboratory) USA (7‐13 April 2020) |
Not stated | RT‐PCR (in‐house SHC assay ) Target: E gene |
As for index test; NP swab Timing of reference: not stated Interval from/to index test: not stated but implies that both tests undertaken in laboratory soon after sample collection |
None reported 3 invalid results were re‐tested; 1 positive and 2 negative Reference: none reported Index: 1 known RT‐PCR‐positive sample that showed a faint positive test line was re‐tested and again showed the same faint test line (considered positive) |
|
Lieberman 2020 (Accepted manuscript) 169 samples (87 cases); data for Xpert Xpress available for only 26 samples (13 cases) |
Single group Samples submitted for clinical diagnostic testing (not all samples analysed for all tests) |
Not stated, sampled from laboratory USA (Not stated) |
Not stated High viral load (≤ 30 Ct): 6, 46% (reported for 13 samples) |
RT‐PCR (UW CDC EUA‐based in‐house test) Threshold: positive if 1 of 2 targets detected ‐ presume at <40 Ct Target: NI, N2 genes |
As for index test; NP swab Timing of reference: not stated Interval from/to index test: all testing conducted within 72 h |
None reported; additional data reported comparing Panther Fusion with DiaSorin Simplexa Not stated Reference: inconclusive' results (i.e. 1 genetic target detected) considered positive due to the high specificity of all assays and limited cross‐reactivity seen for SARS‐CoV‐2 primer sets Index: same as above |
|
Loeffelholz 2020 (Accepted manuscript) 486 samples (220 cases) |
Two groups; deliberate sampling to enrich for positive specimens Suspected patients referred for COVID‐19 testing at 7 sites according to the local criteria; one site (LAC+USC) tested specimens from a 4‐day point prevalence survey of patients presenting with COVID‐19 symptoms |
Not stated USA, UK, France, Italy (1 March‐2 April 2020) |
Adults at all sites (all age groups at New York City Dept. Health and Mental Hygiene and Niguarda Hospital) | RT‐PCR (8 different kits used at different sites)
Target:
Tie‐breaker methods (for discrepant results), included: Hologic Panther Fusion (San Diego, USA), Tib‐Molbiol LightMix Modular Wuhan Coronavirus E‐gene RT‐PCR (Roche, Basel, Switzerland); and the CDC assay (IDT primers and probes) |
As for index test Timing of reference: as for index test Interval from/to index test: same samples but index test performed after frozen storage for undefined period of time (except at University Hospital, Newark where specimens were tested in real time, within 2 h by the index test) |
4 Xpert Xpress test results were lost permanently due to a single instrument computer malfunction and 1 invalid result excluded 1 Xpert Xpress test was invalid due to a cartridge error (inadequate sample volume) Reference: specimens with inconclusive results by a test, and those with discrepant results between index and the RT‐PCR tests were analysed by a third RT‐PCR method (see Table 4). 12 specimens (8 NPS, 4 NPS/OPS) were inconclusive and considered positive for data analysis purposes in the study. 1 NPS specimen was inconclusive by the Quest SARS‐CoV‐2 rRT‐PCR test and negative by the Xpert test. This specimen was negative by a tie‐breaker NAAT. Index: presumptive positive results on index test were not reanalysed by the index test, but all discrepant results were reanalysed by a third RT‐PCR method |
|
Mitchell 2020 (Accepted manuscript) 61 samples (46 cases) |
Single group Samples positive and negative on 1/2 SARS‐CoV‐2 RT‐PCR assays |
Not stated; 2 independent laboratories USA (Not stated) |
Not stated High viral load (≤ 30 Ct): 15, 33% (reported for 46 samples) |
RT‐PCR (2 different in‐house kits used) CDC EUA and NY RT‐PCR Target: not stated |
As for index test Timing of reference: as for index test Interval from/to index test: same samples but used at different times (samples used for index test stored at −80 ℃) |
None reported None reported Reference: none reported Index: none reported |
|
Moore 2020 (Preprint) 200 samples (125 cases) |
Two groups; consecutive (n = 94), then deliberate sampling of all PCR‐positive samples plus the next PCR‐negative sample after each positive Samples from symptomatic (fever or cough or shortness of breath) adult and paediatric outpatients, ED patients, and inpatients |
Mixed (outpatients, ED patients and inpatients) USA (27 March‐9 April 2020) |
79 (39.5%) hospitalised including 29 in ICU, 76 (38%) ambulatory care including 55 seen in a designated COVID‐19 screening clinic, and 45 (23%) seen at ED; 92 male (46%); mean age 50 years (SD 17) |
RT‐PCR (2 different methods used in all samples)
Threshold: [1] positive result required Ct <40 for both targets; negative if neither target detected and positive amplification curve for control (RP) gene; inconclusive if only one target detected at Ct<40, and test repeated [2] amplification curves reported as detected or not detected; Target: [1]N1, N2 genes [2]N, RdRp genes |
As for index test; NP swab Timing of reference: not stated Interval from/to index test: all 3 tests conducted within 72 h of sample collection |
2 invalid excluded 2 results were invalid on ID Now and were not retested (excluded) Reference: discordant results on RT‐PCR had record review to determine presence/absence COVID‐19 infection Index: none reported |
|
Moran 2020 (Accepted manuscript) 103 samples (42 cases) |
Single group Specimens collected from inpatients and ambulatory patients at the University of Chicago |
Mixed (inpatient and ambulatory); samples selected from central laboratory USA (Not stated) |
Not stated | RT‐PCR (Roche cobas SARS‐CoV‐2 assay on the cobas 6800 system (Roche Molecular Systems, Branchburg, NJ)) Target: ORF1, E genes |
As for index; nasal or NP swabs Timing of reference: not stated Interval from/to index test: same sample and appear to have both been conducted soon after sample collection |
None reported None reported Reference: single FP was retested on RT‐PCR and found to be repeatedly negative Index: single FP was retested with index test and considered negative on both targets |
|
Rhoads 2020 (Accepted manuscript) 96 samples (96 cases) |
Single group (cases); Samples positive using standard of care testing |
Not stated; includes self‐collected and provided‐collected samples USA (Not stated) |
Not stated | Standard of care testing for original samples; remnant samples re‐tested with modified CDC RT‐PCR (using 7500 Fast instrument and using alternate RNA extraction Threshold: samples with one positive target detected considered positive instead of "inconclusive" Target: N1 and N2 genes |
As for index test Timing of reference: as for index test Interval from/to index test: same samples used |
None reported None reported Reference: RT‐PCR detected only 1/2 targets for 2 samples (both considered positive and diagnosed as positive on original sample testing); both were negative on index test) Index: none reported |
|
Smithgall 2020 [A] (Published) 113 samples (88 cases) |
Two groups; deliberate sampling of samples with high, medium and low Ct values on the reference standard RT‐PCR Patients undergoing routine clinical testing by RT‐PCR |
Mixed; in‐patient and ED USA (8‐13 April 2020) |
111 adults (range 23‐101 years; mean 65 years for RT‐PCR‐positive and 43 years for RT‐PCR‐negative; 2 paediatric (age 1 day and 5 days); 61 male (54%) High viral load (≤ 30 Ct): 53, 60% (reported for 88 samples) |
RT‐PCR (cobas SARS‐CoV‐2 assay on the 6800 platform (Roche Diagnostics, Indianapolis, IN)); Threshold: not stated, all Ct values < 37 on both target genes Target: ORF1 a/b, E‐gene |
As for index test Timing of reference: as for index test Interval from/to index test: simultaneous; same samples used |
None reported None reported Reference: none reported Index: 1 sample was a presumptive positive based on detection of E‐gene target but not the N2 target |
|
Wolters 2020 (Accepted manuscript) 88 samples (58 cases) |
Two groups; deliberate sampling according to target gene Samples selected from laboratories on the basis of E gene or RdRp on RT‐PCR (n = 88) |
Not stated; 3 laboratories The Netherlands (January‐March 2020) |
Not stated High viral load (≤ 30 Ct): 24, 41% (reported for 58 samples) |
In‐house RT‐PCR (3 different kits at different laboratories) Target:
|
As for index test Timing of reference: as for index test Interval from/to index test: same samples used; index text seems to have been conducted after frozen storage |
None reported None reported Reference: re‐testing of the FN and presumptive positive samples with RT‐PCR (see Table 4); Index: 1 sample was positive only on N2 gene (considered negative according to IFU) and one was positive only on E gene (considered presumptive positive, requiring re‐testing according to IFU). Both samples were re‐tested on RT‐PCR only |
|
Zhen 2020 [A] (Accepted manuscript) 108 samples (58 cases) |
Two groups; deliberate sampling to represent the true positivity rate at study authors' institution (50%‐60%), and to span low and high viral loads Samples from symptomatic patients of all ages and gender |
Not stated; selected from laboratory USA (March‐April 2020) |
Symptomatic; all ages and gender |
RT‐PCR (Hologic Panther Fusion SARS‐CoV‐2 assay) Target: 2 regions of ORF1ab; either positive |
As for index; NP swabs Timing of reference: not stated Interval from/to index test: not stated in exact terms; delay between index and reference only for GenMark assay, as 88 samples tested at time of collection with ePlex then frozen before testing with all other assays |
1 invalid excluded 1 specimen with invalid result on ID Now excluded from that dataset Reference: none reported; no re‐testing conducted Index: none reported; no re‐testing conducted |
| BAL: bronchoalveolar lavage; CDC: Centers for Disease Control; Ct: cycle threshold; ED: emergency department; EUA: emergency use authorisation; FN: false negative; FP: false positive; ICU: intensive care unit; IFU: instructions for use; IQR: interquartile range; NAAT: nucleic acids amplification test; NOP: naso‐oropharyngeal; NP: nasopharyngeal; OP: oropharyngeal; PHE: Public Health England; qRT‐PCR: quantitative reverse transcription polymerase chain reaction; RT‐PCR: reverse transcription polymerase chain reaction; UV: ultraviolet; UW: University of Washington; VTM: viral transport medium | ||||||
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