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

Haljasmagi 2020.

Study characteristics
Patient Sampling Purpose: Detection of acute and convalescent‐phase SARS‐CoV‐2 antibodies
Design: Two‐group study estimating sensitivity and specificity:
[1] PCR‐confirmed hospitalised Covid‐19 patients (n = 26)
[2] Healthy controls without recent infection or Covid‐19 symptoms (fever or cough) for last month) (n = 26)
Recruitment: Unclear
Prospective or retrospective: Unclear
Sample size: 52 (26)
Further detail: No more details available
Patient characteristics and setting Setting: Hospital inpatient
Location: Tartu University Hospital
Country: Estonia
Dates: Not stated
Symptoms and severity: Not described
Demographics: Median age 62 y (range 33‐91 y); 18, 51% male [calculated from Suppl Tabl 1]
Exposure history: Not described
Non‐Covid group 1: Contemporaneous apparently healthy controls
Source: Unclear
Characteristics: Without recent infection or Covid‐19 symptoms (fever or cough) for previous month; age range 23‐54 years No further details
Index tests Test name: Anti‐SARS‐CoV‐2 IgG ELISA
Manufacturer: Euroimmun, Germany
Antibody: IgG
Antigen target: S1
Evaluation setting: Laboratory, laboratory
Test method: ELISA
Timing of samples: median 16 days (range 8 to 37 d)
Day 8‐14 after infection: 9/26 (35%)
Day 15‐21 after infection: 11/26 (42%)
Day 22+ after infection: 6/26 (23%)
Samples used: Plasma
Test operator: Unclear
Definition of test positivity: "According to the manufacturer’s recommendations, a ratio < 0.8 is
considered negative, ≥ 0.8 and < 1.1 borderline, and ≥ 1.1 positive."
Blinding reported: Unclear
Threshold predefined: Yes, as per manufacturer
Target condition and reference standard(s) Reference standard: PCR; no further details
Samples used: Unclear
Timing of reference standard: Unclear
Blinded to index test: Unclear
Incorporated index test: No
Definition of non‐COVID cases: Unclear, no SARS‐CoV‐2 testing reported
Samples used: Unclear, possibly none
Timing of reference standard: Unclear
Blinded to index test: Unclear
Incorporated index test: No
Flow and timing Time interval between index and reference tests: Unclear
All patients received same reference standard: No (controls had different reference)
Missing data: Nothing mentioned
Uninterpretable results: Nothing mentioned
Indeterminate results: Nothing mentioned
Unit of analysis: Patients
Comparative  
Notes Funding: "The study was supported by the Estonian Research Council grants [#] (PP) and [#] (K.K.)"
Publication status: Published letter
Source: European Journal of Immunology
Author COI: The authors declared no commercial or financial conflict of interests.
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?     Low concern
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition? Unclear    
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? Unclear    
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