| Study characteristics |
| Patient Sampling |
Purpose: Single‐group study recruiting patients estimating sensitivity
Design: [1] Hospitalised patients with confirmed COVID‐19
Recruitment: cases with residual serum samples collected between 18 March‐26 March 2020
Prospective or retrospective recruitment of cases: retrospective
Sample size (virus/COVID cases): 37 (37)
Inclusion and exclusion criteria: Not stated |
| Patient characteristics and setting |
Setting: inpatient
Location: University Hospital of Padova
Country: Italy
Dates: 18 March‐26 March 2020
Symptoms and severity: NR
Sex: NR
Age: NR
Exposure history: NR |
| Index tests |
Test name: MAGLUMI 2000 Plus nCoV IgM and IgG
Manufacturer: New Industries Biomedical Engineering Co., Ltd [Snibe], Shenzhen, China
Ab targets: IgM; IgG
Antigens used: NR
Test method: CLIA
Timing of samples: days since symptom onset: ≤ 5 days 4/37 (11%)
6‐7 days 6/37 (16%)
0‐7 days: 10/37 (27%)
8‐9 days 12/37 (32%)
10‐11 days 14/37 (38%)
12‐13 days 9/37 (24%)
8‐13 days: 35/37 (95%)
> 13 days 25/37 (68%)
Samples used: serum
Test operators: NR
Definition of test positivity:
[A] IgM 1.0 AU/mL
[B] IgG 1.1 AU/mL
Blinded to reference standard: no
Threshold predefined: yes |
| Target condition and reference standard(s) |
Reference standard for cases: PCR
Samples used: NP
Timing of reference standard: NR
Blinded to index test: yes
Incorporated index test: no
Reference standard for non‐cases: NA |
| Flow and timing |
Time interval between index and reference tests: NR
Results presented by time period: yes
All participants received the same reference standard: yes
Missing data: text described 87 samples from 37 participants but only 70 samples reported per time period and no per participant data were reported
Uninterpretable results: NR
Indeterminate results: NR
Unit of analysis: sample |
| Comparative |
|
| Notes |
Funding: none declared
Publication status: published
Source: Clinical Chemistry and Laboratory Medicine
Study author COI: none declared |
| Methodological quality |
| Item |
Authors' judgement |
Risk of bias |
Applicability concerns |
| DOMAIN 1: Patient Selection |
| Was a consecutive or random sample of patients enrolled? |
No |
|
|
| 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? |
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? |
|
|
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? |
Yes |
|
|
| Were all patients included in the analysis? |
No |
|
|
| Did all participants receive a reference standard? |
Yes |
|
|
| Were results presented per patient? |
No |
|
|
| Could the patient flow have introduced bias? |
|
High risk |
|
