Kohmer 2020b [A].
Study characteristics | |||
Patient Sampling | Purpose: Assessment of clinical performance of multiple COVID‐19 tests Design: Multi‐group study estimating both sensitivity and specificity Group [1]: Symptomatic PCR‐confirmed COVID‐19 cases (n = 45) Group [2]: Other known infections (other coronaviruses, EBV, CMV) including some pre‐pandemic (n = 37); review team excluded 6 samples with serologically confirmed SARS‐COV‐2 infection based on PRNT) Recruitment: Unclear Prospective or retrospective: Not stated but likely retrospective Sample size: 82 (45) Further detail: No more details available |
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Patient characteristics and setting | |||
Index tests | Test name: [A] SARS‐CoV‐2 IgG [B] Elecsys Anti‐SARS‐CoV‐2 [C] Liaison SARS‐CoV‐2 S1/S2 IgG [D] COVID‐19 VIRCLIA IgG MONOTEST [E] Anti‐SARS‐CoV‐2 ELISA (IgG) [F] Virotech SARS‐CoV‐2 ELISA IgG Manufacturer: [A] Abbott GbmH, Wiesbaden, Germany [B] Roche Diagnostics International AG, Rotkreuz, Switzerland [C] DiaSorin Deutschland GmbH, Dietzenbach, Germany [D] Vircell Spain S.L.U., Granada, Spain [E] Euroimmun, Lubeck, Germany [F] Virotech Diagnostics GmbH, Russelsheim, Germany Antibody: All tests except for [B]: IgG [B]: total antibody Antigen target: [A] N‐protein [B] N‐protein [C] S1 and S2‐protein [D] S1 and N‐protein [E] S1‐protein [F] N‐protein Evaluation setting: All lab tests, done in lab Test method: [A] Chemiluminescent microparticle assay (CMIA) [B] Electrochemiluminescence immunoassay (ECLIA) [C] Chemiluminescent immunoassay (CLIA) [D] Chemiluminescent immunoassay (CLIA) [E] Enzyme‐linked immunosorbent assay (ELISA) [F] Enzyme‐linked immunosorbent assay (ELISA) Timing of samples: No info regarding time since symptom onset. Group [1A]: collected 2‐49 days after PCR‐positive test. Not stated for the others. Samples used: Serum or plasma Test operator: Not stated Definition of test positivity: [A] positive if index S/C >= 1.4 [B] positive if signal sample/cut‐off >= 1.0 [C] positive if >= 15 AU/mL; equivocal if 12‐15 AU/mL [D] positive if AI >= 1.6; equivocal if AI 1.4‐1.6 [E] positive if ratio >= 1.1; equivocal if ratio 0.8‐1.1 [F] positive if Index > 1.1; equivocal if Index 0.9‐1.1 Blinding reported: Unclear Threshold predefined: Yes, as per manufacturer. However, specified they allocated Euroimmun equivocal as negative (post hoc) |
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Target condition and reference standard(s) | Reference standard: Groups [1A] and [1B]: PCR (not further specified) Samples used: Not stated Timing of reference standard: Not stated Blinded to index test: Yes (done earlier) Incorporated index test: No Definition of non‐COVID cases: Group [2] and [3]: No testing Samples used: Group [2] and [3]: NA Timing of reference standard: Group [2] and [3]: NA Blinded to index test: Group [2] and [3]: NA Incorporated index test: Group [2] and [3]: NA |
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Flow and timing | Time interval between index and reference tests: Group [1A]: index tests done 2 to 49 days after PCR‐positivity (unknown for 4 cases) All patients received same reference standard: No Missing data: None (but not all index tests were used on all samples to assess specificity) Uninterpretable results: Yes, for [B]: 2 "equivocal" results, considered as negative Indeterminate results: None Unit of analysis: Patients |
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Comparative | |||
Notes | Funding: None reported Publication status: Published article Source: Academic journal Author COI: One author received speaker’s fee from Euroimmun (manufacturer of one of the index tests). |
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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? | 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? | No | ||
Did all participants receive a reference standard? | Unclear | ||
Were results presented per patient? | Yes | ||
Could the patient flow have introduced bias? | High risk |