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. 2022 Nov 17;2022(11):CD013652. doi: 10.1002/14651858.CD013652.pub2

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)
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
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
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
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
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
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