Traugott 2020 [A].
Study characteristics | |||
Patient Sampling | Purpose: Diagnosis of acute and convalescent‐phase COVID‐19 Design: Multi‐group study estimating sensitivity and specificity [1] Symptomatic patients with acute PCR‐confirmed COVID‐19 infection (n = 77) [2] Symptomatic patients with negative PCR results (n = 30) [3] Healthy volunteers with negative PCR (n = 30) [4] Stored samples from individuals with previous PCR‐confirmed coronavirus OC43 infection (n = 10); interval from infection to sampling of 4 to 1452 days [5] Pre‐pandemic samples from patients with pneumonia (n = 30) Recruitment: Not stated Prospective or retrospective: Unclear; all recruitment appeared to be retrospective Sample size: 177 (77) |
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Patient characteristics and setting | Setting: Mixed; majority were inpatients at time of sample collection Location: 4th Medical Department, Department of Infectious Diseases and Tropical Medicine, Kaiser‐Franz‐Josef Hospital, Vienna Country: Austria Dates: 27th February to 30th March 2020 Symptoms and severity: 59 (75%) hospitalised due to moderate/severe illness, 17 (22%) 'dismissed to home care', 1 sample from HCW Demographics: Median age 63, range 15‐92; 248/77 (62%) male Exposure history: Not stated Non‐Covid group 1: [2] Symptomatic COVID‐19 suspects Source: [2] 27th February to 30th March 2020 Characteristics: [2] No further details per group; overall 40% male, median age 49 y (2–93 y) [3] Healthy volunteers [4] Other coronavirus [5] Pre‐pandemic pneumonia Source: [3] Contemporaneous [4] Unclear; 'stored' [5] Before December 2019 Characteristics: [3] No further details per group [4] previous PCR‐confirmed coronavirus OC43 infections [5] No further details per group |
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Index tests | Test name: [A] Euroimmun SARS‐CoV‐2 IgA ELISA [B] Euroimmun SARS‐CoV‐2 IgG ELISA [C] Wantai SARS‐CoV‐2 IgM ELISA [D] Wantai SARS‐CoV‐2 total antibody ELISA [E] Wantai SARS‐CoV‐2 Ab Rapid Test [F] Hangzhou Alltest 2019‐nCoV IgG/IgM Rapid Test Manufacturer: [A], [B] Euroimmun, Germany [C] to [E] Beijing Wantai Biological Pharmacy, China [F] Hangzhou AllTest Biotech, China Antibody: [A] IgA [B] IgG [C] IgM [D] total antibody [E] Total antibody [F] IgG/IgM Antigen target: [A], [B] S1 domain of the spike‐protein [C], [D] Spike‐protein receptor binding domain [E], [F] Not stated Evaluation setting: [A] to [D] Laboratory [E], [F] Laboratory, but intended as a POC Test method: [A] to [D] ELISA [E], [F] Lateral flow assay Timing of samples: PCR+ cases only: 1‐5 days post‐symptom onset: 30 (39%) 6‐10 days post‐symptom onset: 25 (32%) 11‐29 days post‐symptom onset: 22 (29%) Timing of samples: PCR+ cases only: 1‐5 days post‐symptom onset: 30 (39%) 6‐10 days post‐symptom onset: 25 (32%) 11‐29 days post‐symptom onset: 22 (29%) Samples used: Serum or plasma Test operator: Laboratory staff Definition of test positivity: [A] to [D] Positive when antibody ratio was > 1.1 [E],[F] All tests with (still) visible bands [to the naked eye] were considered positive. Blinding reported: Unclear Threshold predefined: Yes, as per manufacturer |
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Target condition and reference standard(s) | Reference standard: RT‐PCR with WHO‐recommended primers and probe located in the E‐gene Samples used: Nasopharyngeal swab/respiratory secretion samples Timing of reference standard: Not stated Blinded to index test: Unclear; but likely conducted first Incorporated index test: No Definition of non‐COVID cases: [2] RT‐PCR [3] RT‐PCR [4] Unclear ('stored') [5] Pre‐pandemic Samples used: [2], [3] Nasopharyngeal swab/respiratory secretion samples Timing of reference standard: [2], [3] Unclear, but contemporaneous [4] Unclear [5] Pre‐pandemic Blinded to index test: [2], [3] Unclear ‐ likely conducted first [4] Yes, it seems these stored samples were from before the observational period [5] Yes, pre‐pandemic Incorporated index test: No |
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Flow and timing | Time interval between index and reference tests: Unclear All patients received same reference standard: No Missing data: None reported Uninterpretable results: None reported Indeterminate results: No All indeterminate results (0.8 to 1.1) on ELISA were counted as index‐negative; weakly positive rapid test results counted as positive Unit of analysis: Patients; only included one sample per patient |
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Comparative | |||
Notes | Funding: Medical Scientific Fund of the Mayor of the City of Vienna Publication status: Published paper Source: Journal of Infectious Diseases Author COI: Authors reported no conflicts of interest |
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Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient Selection | |||
Was a consecutive or random sample of patients enrolled? | Unclear | ||
Was a case‐control design avoided? | No | ||
Did the study avoid inappropriate exclusions? | Unclear | ||
Did the study avoid inappropriate inclusions? | Unclear | ||
Could the selection of patients have introduced bias? | High risk | ||
Are there concerns that the included patients and setting do not match the review question? | High | ||
DOMAIN 2: Index Test (All tests) | |||
DOMAIN 2: Index Test (Antibody tests) | |||
Were the index test results interpreted without knowledge of the results of the reference standard? | Unclear | ||
If a threshold was used, was it pre‐specified? | Yes | ||
Could the conduct or interpretation of the index test have introduced bias? | Unclear risk | ||
Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Unclear | ||
DOMAIN 3: Reference Standard | |||
Is the reference standards likely to correctly classify the target condition? | Yes | ||
Were the reference standard results interpreted without knowledge of the results of the index tests? | Unclear | ||
The reference standard does not incorporate the index test | Yes | ||
Could the reference standard, its conduct, or its interpretation have introduced bias? | Unclear risk | ||
Are there concerns that the target condition as defined by the reference standard does not match the question? | High | ||
DOMAIN 4: Flow and Timing | |||
Was there an appropriate interval between index test and reference standard? | Unclear | ||
Did all patients receive the same reference standard? | No | ||
Were all patients included in the analysis? | Unclear | ||
Did all participants receive a reference standard? | Unclear | ||
Were results presented per patient? | Yes | ||
Could the patient flow have introduced bias? | High risk |