Shamsollahi 2020.
Study characteristics | |||
Patient Sampling | Purpose: Two‐group study to evaluate the sensitivity and specificity of a rapid serological test for diagnosis of active or previous COVID‐19 using serum samples Design: [1] 114 RT PCR‐confirmed COVID‐19 patients in hospitals affiliated to Tehran University of Medical Sciences in 2020 [2] 198 frozen serum specimens taken from healthy people in summer and autumn 2019 (pre‐COVID‐19) From group [1], time split 0‐19 days pso was excluded from our review (n = 31). Recruitment: COVID‐19 cases were PCR‐confirmed patients in hospitals affiliated to Tehran University of Medical Sciences in 2020; test‐negative controls were a random sample of frozen serum specimens from healthy people participating in a Tehran University of Medical Sciences Employees COHORT study, taken in summer and autumn 2019 (months before reporting the first case of COVID‐19 by China) Prospective or retrospective: Unclear Sample size: 312 (114) of which 312 (83) were eligible for our review Further detail: No more details available |
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Patient characteristics and setting | Setting: RT‐PCR‐confirmed COVID‐19 cases in several hospitals ‐ unclear whether inpatient or outpatient Location: Several hospitals affiliated to Tehran University of Medical Sciences Country: Iran Dates: Unclear Symptoms and severity: Not stated Demographics: Average age: 44.0 (± 12.1) years Exposure history: Not stated Non‐Covid group 1: Pre‐pandemic negative controls Source: healthy people participating in a Tehran University of Medical Sciences Employees COHORT study, taken in summer and autumn 2019 Characteristics: Average age: 39.2 (± 8.0) years |
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Index tests | Test name: “VivaDiag” COVID‐19 IgM/IgG Manufacturer: VivaChek Inc., China Antibody: IgM, IgG Antigen target: Not stated Evaluation setting: POC test; unclear where testing was done for cases; as negative controls were frozen samples, these must have been done in a laboratory Test method: Not stated (Seemed to be colloidal gold from website) Timing of samples: 5‐53 days (mean: 27.9) pso 0‐19 days pso: 31/114 (27.2%) 20‐39 days pso 65/114 (57.0%) 40+ days pso: 18/114 (15.8%) Samples used: 10 μL (whole) blood for cases or frozen serum for pre‐pandemic samples Test operator: Not stated Definition of test positivity: Not stated ; "Based on kit instructions" Visual‐based Blinding reported: No; tests appeared to have been conducted separately for known positives and for known negatives (which had to be thawed before testing) Threshold predefined: Based on kit instructions (visual‐based) |
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Target condition and reference standard(s) | Reference standard: RT‐PCR ‐ no threshold reported Samples used: Not stated Timing of reference standard: Not stated Blinded to index test: Yes. For cases, samples were already PT PCR‐confirmed when index test used. Incorporated index test: No Definition of non‐COVID cases: Pre‐pandemic blood samples. No report of these being tested by RT‐PCR Samples used: 10 μL blood Timing of reference standard: Pre‐pandemic blood samples. Blinded to index test: Yes. For controls, blood samples were drawn months before the study. Incorporated index test: No |
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Flow and timing | Time interval between index and reference tests: Not stated for cases; pre‐pandemic controls All patients received same reference standard: No (PCR test for cases, pre‐pandemic samples for controls) Missing data: Not stated Uninterpretable results: Not stated Indeterminate results: Not stated Unit of analysis: 1 sample per patient. |
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Comparative | |||
Notes | Funding: Not stated; VivaDiag kit donated to Tehran University of Medical Sciences (TUMS) by the Ministry of Health and Medical Education (MOHME) Publication status: Preprint, now published Source: Preprint server ‐ medRxiv Journal (Archives of Iranian Medicine) Author COI: The authors declared no conflict 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? | No | ||
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? | No | ||
If a threshold was used, was it pre‐specified? | Yes | ||
Could the conduct or interpretation of the index test have introduced bias? | High 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? | Unclear | ||
Were the reference standard results interpreted without knowledge of the results of the index tests? | Yes | ||
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? | Yes | ||
Did all participants receive a reference standard? | Unclear | ||
Were results presented per patient? | Yes | ||
Could the patient flow have introduced bias? | High risk |