Wang 2020a.
| Study characteristics | |||
| Patient Sampling | Purpose: Diagnosis of acute and convalescent‐phase infection Design: Single‐group study to estimate sensitivity and specificity in: [1] patients who visited the hospital with respiratory complaints during January to March 2020 (n = 375) Recruitment: Consecutive (all patients in a time period) Prospective or retrospective: Retrospective Sample size: 375 (141) Further detail: No more details available |
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| Patient characteristics and setting | Setting: Hospital inpatient Location: First People’s Hospital of Jingmen, Hubei Province Country: China Dates: 25th January to 16th March 2020 Symptoms and severity: Not reported Demographics: 65 (46%) male, median age 58 years, range 21 to 95 years Exposure history: Unclear |
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| Index tests | Test name: Xiamen Biotime IgG/IgM Manufacturer: Xiamen Wantai Kairui Biological Tecnhology Co. Ltd, China Antibody: Total antibody Antigen target: Recombinant antigens containing the receptor binding domain (RBD) Evaluation setting: Laboratory Test method: CLIA Timing of samples: Day 0 to > 20 days pso; 0‐10 days after symptom onset: 61 (43%) 11‐20 days after symptom onset: 72 (51%) 21+ days after symptom onset: 8 (6%) Samples used: Serum Test operator: Unclear Definition of test positivity: Signal‐to‐cut off ratio >= 1 represented antibody positivity. Blinding reported: Unclear Threshold predefined: Yes |
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| Target condition and reference standard(s) | Reference standard: New Coronavirus Pneumonia Prevention and Control Program (7th edition) definition; specifically:
[1] RT‐PCR (Applied Biosystems ViiA7 Dx (Applied Biosystems, Singapore) and RT‐PCR reagent BioGerm (Shanghai BioGerm Medical Technology Co., Ltd.); threshold > 40 Ct defined negative, or
[2] RT‐PCR‐negative with characteristic CT changes of the lungs Samples used: Throat swabs Timing of reference standard: Of 1415 cases: 39.7% positive day 0‐3 62.4% positive by day 5 86.7% positive by day 7 92.2% positive by day 10 or more 11 patients remained PCR‐negative Blinded to index test: Yes Incorporated index test: No |
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| Flow and timing | Time interval between index and reference tests: Varied, as reference tests were repeated up to 5 times until positive, and index tests were performed on discharge Missing data: None reported Uninterpretable results: None reported Indeterminate results:None reported Unit of analysis: Patients |
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| Comparative | |||
| Notes | Funding: None reported Publication status: Published paper Source: Journal of Virological Methods Author COI: The author declared that there was no conflict of interest related to this article content. |
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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? | Yes | ||
| Did the study avoid inappropriate exclusions? | Yes | ||
| Did the study avoid inappropriate inclusions? | Yes | ||
| Could the selection of patients have introduced bias? | Low risk | ||
| Are there concerns that the included patients and setting do not match the review question? | Low concern | ||
| 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? | No | ||
| 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? | Low concern | ||
| 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? | Yes | ||
| Were all patients included in the analysis? | Unclear | ||
| Did all participants receive a reference standard? | Yes | ||
| Were results presented per patient? | Yes | ||
| Could the patient flow have introduced bias? | Unclear risk | ||