Sterlin 2021 [A].
| Study characteristics | |||
| Patient Sampling | Purpose: To evaluate immune response in individuals with SARS‐CoV‐2 infection
1‐group study to estimate sensitivity for diagnosis of active disease and identification of previous disease Design: Group [1]: PCR‐confirmed adult COVID‐19 cases (n = 135) Group [2]: Age‐ and sex‐matched healthy donors (n = 20) Group [3]: 10 cases with CT scan displaying features suggesting a COVID‐19 infection and tested positive for the presence of serum anti‐SARSCoV‐2 antibodies Group [2] was excluded from the review as < 25 controls. Group [3] was excluded as < 10 cases and no test accuracy outcomes. Recruitment: [1] Consecutive [2] Age‐ and sex‐matched [3] Not stated Prospective or retrospective: Prospective (patients gave informed consent and samples were immediately collected) Sample size: 155 (135) of which only 135 (135) cases/214 (214) samples were eligible for our review Further detail: No more details available |
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| Patient characteristics and setting | Setting: Hospital inpatient Location: Department of Internal Medicine 2, Pitié‐Salpêtrière Hospital, Paris Country: France Dates: March 22 to April 24, 2020 Symptoms and severity: All symptomatic and hospitalised 39/135 (29%) admitted to ICU (severe/critical) Pneumonia 123 (91%)
Acute respiratory distress syndrome 13 (10%) Heart failure 5 (4%) Acute renal injury 15 (11%) Demographics: Age, median (IQR: 61.3 y (49.7‐72.0); sex: 55/135 (41%) female Exposure history: Not stated |
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| Index tests | Test name: Maverick SARS‐CoV‐2 Multi‐Antigen Serology Panel Manufacturer: Genalyte Inc., USA Antibody: IgA, IgM, IgG Antigen target: N, S1 RBD, S1/S2, S2 and S1 (multiplex format based on photonic ring resonance technology) Evaluation setting: Lab test, done in lab Test method: Photonic ring immunoassay Timing of samples: Multiple samples obtained from each patient (214 samples from 135 patients): 48 samples collected 1‐7 days pso; 8‐14 days pso: 81/214 15‐21 days pso: 39/214 22‐28 days pso: 20/214 > 28 days pso: 26/214 Samples used: Serum Test operator: Not stated Definition of test positivity: 20 sera collected before December 2019 were analysed to calculate cut‐off values. Positivity was defined as results above the 99th percentile. Blinding reported: Not stated Threshold predefined: Yes, 20 sera collected before December 2019 (independent samples) were analysed to calculate cut‐off values. Positivity was defined as results above the 99th percentile. |
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| Target condition and reference standard(s) | Reference standard: RT‐PCR assay (no more details available) Samples used: Nasopharyngeal swabs Timing of reference standard: Not stated Blinded to index test: Unclear, but likely done earlier Incorporated index test: No |
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| Flow and timing | Time interval between index and reference tests: Not stated All patients received same reference standard: Unclear (PCR test used not mentioned ‐ perhaps different tests used for different patients) Missing data: Unclear (numbers not provided in the text, figures hard to interpret because of overlapping circles) Uninterpretable results: Not stated Indeterminate results: Not stated Unit of analysis: Samples |
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| Comparative | |||
| Notes | Funding: This work was supported by Fondation de France, Tous unis contre le virus framework Alliance (Fondation de France, AP‐HP, Institut Pasteur) in collaboration with Agence Nationale de la Recherche (ANR Flash COVID19 programme), and by the SARS‐CoV‐2 Program of the Faculty of Medicine from Sorbonne University ICOViD programs, PI: G.G.).
One author received a Pasteur/APHP interface fellowship for this study. Publication status: Pre‐print paper Source: Pre‐print server (medXriv) Author COI: One author received consulting fees from Genalyte Inc. 3 years ago. |
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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? | Yes | ||
| 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? | Yes | ||
| 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? | Low 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? | Yes | ||
| Did all participants receive a reference standard? | Unclear | ||
| Were results presented per patient? | No | ||
| Could the patient flow have introduced bias? | High risk | ||