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 |
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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 |
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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 |
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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 |
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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 |
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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. |
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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? | 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 |