Zhang 1992.
Study characteristics | |||
Patient sampling | Unclear study design, selection procedures not reported. | ||
Patient characteristics and setting | Sample size: 132 cases, 43 non‐cases (total 175) Clinical presentation: NR Risk factors: NR Region: China Clinical setting: NR Prevalence of leptospirosis: 75.4% (assuming cross‐sectional design) DPO of disease at moment of enrolment: NR ("early") |
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Index tests |
Index test: PCR Target gene: 23S rRNA (Zhang 1992) Timing of sample collection at # DPO of disease: 1–5 DPO Cut‐off value: not applicable Patient material: serum Company/brand: inhouse Frozen samples: unclear |
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Target condition and reference standard(s) | Target condition: leptospirosis Case definition: MAT positive or culture positive, or both Timing of sample collection at # DPO of disease (MAT): 1–5 DPO and 14–21 DPO Single or paired sera (MAT): paired Cut‐off value (MAT): seroconversion or a 4‐fold titre rise Patient material (MAT): serum Timing of sample collection at # DPO of disease (culture): 1–5 DPO Patient material (culture): whole blood |
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Flow and timing | All people were included in the analysis. | ||
Comparative | |||
Notes | |||
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 2‐gate case‐control design avoided? | Yes | ||
Did the study avoid inappropriate exclusions? | Unclear | ||
Unclear | Unclear | ||
DOMAIN 2: Index Test PCR | |||
Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | ||
If a threshold was used, was it pre‐specified? | Yes | ||
Does the index test, its conduct and interpretation, match the review question? | Unclear | ||
Is the execution of the test reported in such detail that reproduction is possible? | No | ||
Low | High | ||
DOMAIN 3: Reference Standard | |||
Is this the type of test that is likely to correctly classify the target condition? | Yes | ||
Did the execution of the MAT include paired samples? | Unclear | ||
Were the reference standard results interpreted without knowledge of the results of the index tests? | Yes | ||
Does the case definition match the review question? | Yes | ||
Is the execution of the test reported in such detail that reproduction is possible? | No | ||
Low | High | ||
DOMAIN 4: Flow and Timing | |||
Was there an appropriate interval between index test and reference standard? | Unclear | ||
Did all patients receive a reference standard? | Yes | ||
Did all patients receive the same reference standard? | Yes | ||
Were all patients included in the analysis? | Yes | ||
Low |
Ct: threshold cycle; DPO: days postonset; EDTA: ethylenediaminetetraacetic acid; ICG‐LFA: immunochromatography‐based lateral flow assay; ICU: intensive care unit; IgM ELISA: immunoglobulin M enzyme‐linked immunosorbent assay; IQR: interquartile range; LAMP: loop‐mediated isothermal amplification; MAT: microscopic agglutination test; NR: not reported; PCR: polymerase chain reaction; rDNA: ribosomal DNA; rRNA: ribosomal ribonucleic acid.