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. 2019 Aug 1;2019(8):CD011871. doi: 10.1002/14651858.CD011871.pub2

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")
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
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
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.