Study	Study design; inclusion criteria	Setting; country (recruitment dates)	Participant characteristics	Reference standard Samples and timing	Missing data or uninterpretable results
Assennato 2020 Preprint 172 (88; 91 after retesting with RT‐PCR)	Single group; symptomatic individuals with suspected COVID‐19 sent for routine laboratory diagnosis; supplied via PHE Recruitment: not stated	Laboratory‐based (no further details); UK (Not stated)	‘symptomatic'; no further details Not stated	RT‐PCR (single assay); Threshold ≤ 36 Ct Target: (1) RdRp, E gene (2) RdRp 'different region' As for index; combined nose and throat swab in VTM Timing: not stated Interval: not stated; seems likely reference was carried out for routine diagnostic testing	None reported Index: 3 FP and 1 FN result retested using SAMBA‐II; same results obtained on repeat Reference: 3 FP and 1 FN result were re‐tested* ‐ all 3 FPs found to be borderline +ve for ≥ 1 target gene on either Colindale or Cambridge (Wuhan) test (reclassified as TP) ‐ the FN result remained +ve on both RT‐PCR assays
Broder 2020 Accepted manuscript 35 (35)	Single group (cases); Samples +ve on RT‐PCR (Roche Cobas 6800) with lower range of viral load (E target Ct ≥ 30) Recruitment: not stated; deliberate sampling according to viral load	Laboratory‐based (not stated); USA (Not stated)	Not stated; lower viral load Not stated	RT‐PCR (single assay) Target: E gene (unclear if other genetic targets as well) N/A As for index test; NP swab Timing: not stated; presume on presentation Interval: same samples; index within 3 days of reference	None reported Index: none reported Reference: samples +ve on reference were tested by in‐house assay using modified CDC protocol
Chen 2020a Published 58 (58); can only include data for 55 +ve on NP swabs	Single group (cases); archived paired samples from COVID‐19 inpatients Recruitment: not stated	Hospital in‐patient (no further detail); People’s Republic of China (Not stated)	Not stated Median age 38 years; 28, 48% male	RT‐PCR (single assay) Target: RdRp N/A only cases included Not stated; infer single ‐ve Same as index test Timing: not stated; prior to index test Interval: simultaneous; same samples	None reported, however 3 samples +ve only on saliva excluded by review team Not stated Index: not stated Reference: none reported
Collier 2020 Preprint and published version (25‐8‐20) 149 (32)	Single group; patients admitted with a possible diagnosis of COVID‐19 Recruitment: consecutive	Hospital inpatient (no further detail); UK (6 April‐2 May 2020)	Not stated Mean age 62.7 years, 70, 47% male	RT‐PCR (single assay) Target: not stated Not stated; separate swab used as participants were excluded if > 18‐h interval between swab collections Timing: not stated Interval: < 18 h	Yes; 5 discarded VTM, 1 timing of PHE swab not reported, 1 inadequate SAMBA swab, 2 swab interval > 24 h Index: not described "Indeterminate … tests were repeated … until a valid result was obtained." Discrepant results re‐tested on original samples Reference: "indeterminate … tests were repeated on a replicate … swab until a valid result was obtained." Discrepant results re‐tested on original samples
Cradic 2020(a) published 184 (33)	Single group; symptomatic patients meeting criteria for testing Recruitment: not stated	Mixed (ED or inpatients); USA (Not stated )	All symptomatic, no further details. Not stated	Composite; result obtained from at least 2 of 3 commercial assays (includes 2 RT‐PCRs and Abbot ID NOW) Target: RdRp, S or ORF1ab gene (either present), ORF1ab or E gene (both present for +ve, either present for presumptive +ve) Same as index test Timing: not stated Interval: simultaneous ‐ same swab	None reported Index: none reported Reference: none reported
Cradic 2020(b) published 182 (13)	Single group; presenting to ED with signs/symptoms of COVID‐19 submitted for routine laboratory testing (n = 182) Recruitment: not stated	Hospital A&E (ED); USA (Not stated )	All symptomatic, no further details. Not stated	RT‐PCR (single assay) Target: S or ORF1ab gene (either present) NP swab in UTM, same as index Timing: not stated Interval: simultaneous; paired swabs	None reported Index: none reported Reference: none reported
Dust 2020 Published 38 (20)	Two‐group; [1] SARS‐CoV‐2 +ve samples submitted for routine viral diagnostic testing [2] samples +ve for other respiratory infection Convenience sampling Recruitment: retrospective	Laboratory‐based (unclear; submitted to laboratory); Canada (Not stated)	Not reported	RT‐PCR (single assay); Ct threshold not stated Target: E, N1 NP (as for index) Timing: not stated Interval: simultaneous (same swab)	None reported Index: none reported Reference: none reported
Ghofrani 2020 Published 113 (17)	Single group Patients with both RT‐PCR and POC test results available (n = 113), including: [1] symptomatic patients with a PCR swab test close to presentation and a re‐swab for POC testing [2] patients with +ve RT‐PCR results and remnant NP swabs available for POC test, [3] asymptomatic patients with +ve POC result on admission who were re‐swabbed for RT‐PCR confirmation. N per group was not reported Recruitment: convenience	Mixed (hospital and community); USA (6 April‐21 April 2020)	'Majority' symptomatic, no further details Not stated	RT‐PCR (no details) Target: not stated Mixed; either paired swabs (within 3 days of each other) or same samples used Timing: not stated Interval: some same sample; paired samples could be up to 3 days apart	None reported Index: none reported Reference: none reported
Gibani 2020 Published 418 ()	Three sources of participants: [1] self‐referred, HCWs or their family members with suspected COVID‐19 who were not admitted to hospital (n = 280) [2] ED patients with suspected COVID‐19 (n = 15) [3] hospital inpatient admissions with or without suspected COVID‐19 (n = 91) Total N 418 paired samples; 32 excluded as invalid (patient group not reported), 24 invalid on DnaNudge and 8 on RT‐PCR) [1] and [2] not reported [3] consecutive Recruitment: prospective	Mixed (community, A&E, inpatient); London or Oxford, UK ([1] 10 April‐12 May [2] 2‐24 April [3] 12‐18 May)	Only group [3] were inpatient median age 46 years (IQR 31–66); 124, 32% male	RT‐PCR (multiple assays) Target: see above NOP (paired) Timing: not stated Interval: simultaneous (paired)	Additional 47 samples not 'paired'; not collected on same date 32 samples excluded; 24 invalid on DNANudge (failed to amplify RNaseP; 22/24 with associated RT‐PCR result were ‐ve) and 8 on RT‐PCR (all 8 from 1 site) Index: none reported Reference: none reported
Goldenberger 2020 Published 19 (10)	Two‐group; [1] SARS‐CoV‐2 +ve samples selected to reflect a broad range of Ct values [2] SARS‐CoV‐2 ‐ve samples (n = 9) Sampled from patients suspected of COVID‐19 undergoing routine diagnostics within a 1‐week period Convenience Recruitment: unclear	Laboratory‐based (unclear); Switzerland (1 week during 2020 pandemic)	Not reported	RT‐PCR (single assay); Threshold NR but all PCR+ < 33 Ct Target: E, ORF1 NP (same as index) Timing: not stated Interval: simultaneous (same swab)	None reported Index: none reported Reference: none reported
Harrington 2020 Accepted manuscript 524 (186)	Single group; Symptomatic patients meeting diagnostic criteria for COVID‐19 Recruitment: consecutive	Hospital A&E (EDs (n = 3) or urgent care centres (n = 2)); USA (Not reported)	Not stated	RT‐PCR (single assay) Target: not stated Not specifically stated; presume yes as central lab used NP swabs (paired) Timing: VTM (no detail) Interval: simultaneous swab collection (different swabs for index and reference)	None reported Index: none reported Reference: 2 initial FPs had repeat sampling: ‐ 1 retested on RT‐PCR only and was +ve (designated as TP) ‐ 1 retested on RT‐PCR and ID Now and was ‐ve on both (designated as TN)
Hogan 2020 Preprint 100 (50)	Single group; adult patients from one hospital and paediatric and adult samples from surrounding hospitals Recruitment: unclear; equal numbers of +ve and ‐ve RT‐PCR samples	Laboratory‐based (clinical virology laboratory); USA (7‐13 April 2020)	Not stated	RT‐PCR (single assay) Target: E gene As for index test; NP swab Timing: not stated Interval: not stated implies tests undertaken soon after collection	None reported 3 invalid results were re‐tested; 1 +ve and 2 ‐ve Index: 1 known RT‐PCR+ sample with faint +ve test line re‐tested (same result; considered +ve) Reference: none reported
Hou 2020 Accepted manuscript 285 (153)	Single group; remnant OP swabs submitted for SARS‐CoV‐2 testing Recruitment: not stated	Laboratory‐based (mixed inpatient and outpatient); China (February‐April 2020)	178 (62.5%) inpatient; 107 (37.5%) outpatients. Site 2 were all inpatients 220 (77.2%) aged ≤ 65 years; 159 (55.8%) male	RT‐PCR (multiple assays) Target: not stated OP (same as for rapid test) Timing: not stated Interval: simultaneous (same swab); time period of frozen storage was not reported	None reported Index: none reported Reference: none reported
Jin 2020 Published 52 (6)	Single group; paired dry swabs and NP or OP swabs in UTM (includes pre‐admission screening for surgical patients) Recruitment: unclear	Laboratory‐based (unclear); USA (23‐26 April 2020)	Not stated	RT‐PCR (single assay) Target: ORF1/a, E gene Not stated for paired samples, but for full cohort NP and OP swabs in VTM used (400 uL) Timing: not stated Interval: simultaneous (paired swabs)	None reported Index: none reported Reference: none reported
Jokela 2020 Preprint 107 (61); only 90 tested with Xpert Xpress	Two‐group: NP or OP swab samples sent to university laboratory: [1] for SARS‐CoV‐2 testing (n = 97), [2] pre‐pandemic samples sent for testing due to suspicion of other respiratory virus infection (n = 10) Recruitment: not stated	Laboratory‐based (not reported); Finland (March‐May 2020)	Not stated	RT‐PCR (multiple assays) Target: 1) N gene, 2) orf1ab and E, 3) orf1ab and N NP or OP, as for index Timing: not stated Interval: simultaneous (same samples)	107 samples tested with Novodiag but only 90 for Xpert None reported Index: none reported Reference: none reported
Lephart 2020 [A] Preprint [1] 75 (16)	Single group; ‐ patients presenting to ED (75) Recruitment: not stated Second cohort of 13 cases excluded	Hospital A&E ([1] ED; [2] in‐patient); USA (22 April‐5 May 2020)	Not reported	Composite: result from ≥ 2 of 4 commercial assays (includes ID NOW and 3 RT‐PCR assays (incl Xpert Xpress)) Target: not stated Three ‐ves (on different assays) required for absence of infection (same as for Xpert Xpress) Timing: within 24 h of sample collection (on presentation at ED); no further detail Interval: same swab [B], or paired collection [A]	None reported Index: [A] no invalid results [B] 1 'invalid' result; not reported if this was a 'presumptive +ve' (E gene only) on Xpert Xpress or no result Reference: none reported
Lieberman 2020 Accepted manuscript 169 (87)	Single group; Samples submitted for clinical diagnostic testing Recruitment: not stated	Laboratory‐based (not reported); USA (Not stated)	Not stated	RT‐PCR (single assay); Threshold not stated Target: NI, N2 As for index test; NP swab Timing: not stated Interval: all testing conducted within 72 h	None reported; review team excluded data for 28 specimens comparing Panther Fusion with DiaSorin Simplexa Not stated Index: not stated Reference: inconclusive' (ie one genetic target detected) considered +ve
Loeffelholz 2020 Accepted manuscript 486 (220)	Two‐group; patients referred for COVID‐19 testing at according to the local criteria Recruitment: convenience; deliberate sampling to enrich for +ve specimens	Laboratory‐based (not stated); USA, UK, France, Italy (1 March‐2 April 2020)	Not stated Adults at all sites except New York City Dept. Health and Mental Hygiene and Niguarda Hospital where all age groups were tested (ages not stated)	RT‐PCR (multiple assays) Target: different targets depending on RT‐PCR test used (see cut‐off index) Same as for index test Timing: as for index test Interval: same samples but majority of index tests performed after frozen storage for undefined period	4 Xpert Xpress test results lost permanently (single instrument computer malfunction); + 1 invalid excluded 1 Xpert Xpress test invalid due to cartridge error Index: presumptive +ve results not reanalysed by Xpert Xpress; all discrepant results reanalysed by a 3rd RT‐PCR method Reference: inconclusive results analyzed by a 3rd RT‐PCR method
Mitchell 2020 Accepted manuscript 61 (46)	Single group; Samples +ve and ‐ve on one of two SARS‐CoV‐2 RT‐PCR assays Recruitment: not stated; possible deliberate sampling of +ve cases	Laboratory‐based (2 independent laboratories); USA (Not stated)	Not stated	RT‐PCR (one of two assays) Target: not stated As for index test Timing: as for index test Interval: same samples but used at different times (samples used for index test stored at −80 ℃)	None reported Index: none reported Reference: none reported
Moore 2020 Preprint 200 (125)	Two‐group; symptomatic (fever or cough or shortness of breath) adult and pediatric outpatients, ED patients, and inpatients Recruitment: consecutive (first 94 participants), then deliberate sampling used	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. Mean age 50 years (SD 17 years), 92 (46%) men	RT‐PCR (multiple assays); Threshold ≤ 40 Ct or presence of amplification curve Target: a. N1, N2 b. N, RdRp As for index test; NP swab Timing: not stated Interval: 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) Index: none reported Reference: discordant results on RT‐PCR had record review to determine presence/absence COVID‐19 infection
Moran 2020 Accepted manuscript 103 (42)	Single group; inpatients and ambulatory patients Recruitment: not stated	Laboratory‐based (inpatient and ambulatory; samples selected from central laboratory); USA (Not stated)	Not stated	RT‐PCR (single assay) Target: ORF1, E As for index; nasal or NP swabs Timing: not stated Interval: not stated; same sample	None reported Index: single FP (‐ve on E gene and low +ve on N gene) retested with Xpert Xpress and considered ‐ve on both targets Reference: single FP was retested on RT‐PCR and found to be repeatedly ‐ve
Rhoads 2020 Accpeted manuscript 96 (96)	Single group (cases); Samples +ve using standard of care testing Recruitment: convenience	Laboratory‐based (includes self‐collected and provided‐collected samples); USA (Not stated)	Not stated	RT‐PCR (multiple assays) Target: N1 and N2 As for index test Timing: as for index test Interval: same samples used	None reported Index: none reported Reference: RT‐PCR detected only one of two targets for two samples (both considered +ve (diagnosed as +ve on original sample testing); both were ‐ve on index test)
Smithgall 2020 [A] Published 113 (88)	Two‐group Routine clinical testing by RT‐PCR Recruitment: unclear; describes deliberate sampling of samples with high, medium and low Ct values on RT‐PCR	Laboratory‐based (inpatient and ED); USA (8 April‐13 April)	Not stated 111 adult (range 23‐101 years; average 65 years for RT‐PCR+ and 43 years for RT‐PCR‐); 2 paediatric (age 1 day and 5 days) 61, 54% male	RT‐PCR (single assay) Threshold ≤ 37 Ct on both target genes Target: ORF1 a/b, E‐gene Not stated As for index test Timing: as for index test Interval: simultaneous; same samples used	None reported Index: Xpert: 1 sample was a presumptive +ve based on detection of E‐gene target but not the N2 target Reference: none reported
SoRelle 2020 Published letter 83 (39)	Unclear design; participants symptomatic for COVID‐19 Sampling: not stated Recruitment: not stated	Laboratory‐based (unclear); USA (Not reported)	All symptomatic Not reported	RT‐PCR (multiple assays) Target: not stated NP in VTM (paired) Timing: not stated Interval: paired	None reported Index: none reported Reference: none reported; presumptive +ves not mentioned
Stevens 2020 Accepted manuscript 104 (54)	Unclear design; Residual samples from symptomatic and asymptomatic individuals undergoing routine testing; selected to represent the full range of Ct values Sampling: convenience Recruitment: retrospective	Laboratory‐based (serving adult and pediatric tertiary care hospitals); USA (31 March‐7 April)	Unclear; 'symptomatic and asymptomatic'; Of 54 cases, 10 (19%) were low viral low (Ct > 35) Not reported	RT‐PCR (single assay) Target: 2 regions of ORF1ab NP in VTM; as for index test Timing: not stated Interval: same sample	6 samples excluded due to insufficient sample volume 1 RT‐PCR+ sample re‐tested on Xpert Xpress due to initial interpretation of no results (invalid); Xpert +ve on re‐test Index: no presumptive +ves were observed Reference: 1 RT‐PCR+ sample that was ‐ve on both targets for Xpert Xpress (FN) was re‐tested on Panther Fusion and found to be ‐ve (TN)
Szymczak 2020 Published 79 (29 +ve on stool; 48 previously +ve on NP/OP swab)	Single group; remnant samples from patients with symptomatic diarrhoea submitted for routine diagnostic testing Recruitment: convenience	Laboratory‐based (unclear); USA (21 April‐15 May 2020)	All symptomatic for diarrhoea Not stated	RT‐PCR (single assay) Target: two ORF1a regions Stool, as for index Timing: some samples frozen at −80 °C prior to testing with Hologic Panther Fusion Interval: simultaneous; same swabs	None reported Index: discrepant results re‐tested with both index and reference test Reference: as above
Thwe 2020 Published 161 (14)	Single group; symptomatic patients with paired samples Sampling: not stated Recruitment: retrospective	Laboratory‐based (inpatient and ED); USA (April‐May 2020 ("4 weeks data"))	All symptomatic Not stated	RT‐PCR (single assay) Target: not stated NP in VTM (paired) Timing: not stated Interval: paired	None reported (review team excluded 21 samples with Xpert Xpress as reference standard) None reported Index: none reported Reference: none reported; no discrepant analysis
Wolters 2020 Accepted manuscript 88 (58)	Two‐group; Samples selected from laboratories on the basis of presence/absence of 2 genetic targets on RT‐PCR Recruitment: not stated; deliberate sampling according to target gene	Laboratory‐based (not stated; 3 laboratories); The Netherlands (January‐March 2020)	Not stated	RT‐PCR (multiple assays) Target: mixed As for index test Timing: as for index test Interval: same samples used; index text seems to have been conducted after frozen storage	None reported Index: samples +ve on only 1 target were both re‐tested on RT‐PCR only Reference: as above
Wong 2020 Published 162 (119)	Single group; samples submitted for routine testing from patients with suspected COVID‐19 infection Sampling: not stated Recruitment: both retrospective (n = 74) and prospective (n = 88)	Laboratory‐based (A&E, inpatient and outpatient); China (Not stated)	Not stated Median age 46 (IQR: 35 (28‐63); male = 69 (44%)	RT‐PCR (single assay) Target: not stated deep throat saliva or lower respiratory tract; as per index test Timing: not stated Interval: simultaneous (same samples)	None reported Index: none reported Reference: none reported
Zhen 2020 [A] Accepted manuscript 108 (58)	Two ‐group; Samples from symptomatic patients of all ages and gender Recruitment: not stated; deliberate sampling to represent the TP rate at authors' institution (50%‐60%), and to span low and high viral loads	Laboratory‐based; USA (March‐April 2020)	"Symptomatic"; no further details Not stated (all ages and gender)	RT‐PCR (single assay) Target: 2 regions of ORF1ab; either +ve single RT‐PCR As for index; NP swabs Timing: not stated Interval: not stated in exact terms	1 specimen with invalid result on ID Now was excluded from that dataset Index: none reported; no re‐testing conducted Reference: none reported; no re‐testing conducted
A&E: Accident and Emergency [Department]; CDC: National Health Commission of the People's Republic of China; Ct: cycle threshold; ED: Emergency Department; FN: false negative; FP: false positive; HCW: healthcare worker; ICU: intensive care unit; IQR: interquartile range; N/A: not applicable; NOP: naso‐oropharyngeal; NP: nasopharyngeal; NR: not reported; OP: oropharyngeal; PHE: Public Health England; RT‐PCR: reverse transcription polymerase chain reaction; TN: true negative; TP: true positive; UTM: universal transport media; VTM: viral transport medium