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

Widiyanti 2013.

Study characteristics
Patient sampling Cross‐sectional study with unclear sampling method.
Patient characteristics and setting Sample size: 28 cases, 16 non‐cases (total 44)
Clinical presentation: NR
Risk factors: NR
Region: Philippines
Clinical setting: NR
Prevalence of leptospirosis: 63.6%
DPO of disease at moment of enrolment: NR
Index tests Index test 1: PCR
Target gene: flaB (Kawabata 2001)
Timing of sample collection at # DPO of disease: median 5.5 (IQR 3–9)
Cut‐off value: not applicable
Patient material: urine
Company/brand: inhouse
Frozen samples: yes
Index test 2: ICG‐based LFA
Target gene: not applicable
Timing of sample collection at # DPO of disease: median 5.5 (IQR 3–9)
Cut‐off value: not applicable
Patient material: urine
Company/brand: inhouse
Frozen samples: yes
Index test 3: dipstick assay
Target gene: not applicable
Timing of sample collection at # DPO of disease: median 5.5 (IQR 3–9)
Cut‐off value: not applicable
Patient material: urine
Company/brand: inhouse
Frozen samples: yes
Target condition and reference standard(s) Target condition: leptospirosis
Case definition: MAT positive
Timing of sample collection at # DPO of disease (MAT): NR (some samples were collected in the acute phase)
Single or paired sera (MAT): single
Cut‐off value (MAT): ≥ 1:400
Patient material (MAT): serum
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? Unclear    
If a threshold was used, was it pre‐specified? Yes    
Does the index test, its conduct and interpretation, match the review question? No    
Is the execution of the test reported in such detail that reproduction is possible? Yes    
    Unclear High
DOMAIN 2: Index Test ICG‐based LFA
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    
Does the index test, its conduct and interpretation, match the review question? No    
Is the execution of the test reported in such detail that reproduction is possible? Yes    
    Unclear High
DOMAIN 2: Index Test Dipstick
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    
Does the index test, its conduct and interpretation, match the review question? No    
Is the execution of the test reported in such detail that reproduction is possible? Yes    
    Unclear High
DOMAIN 3: Reference Standard
Is this the type of test that is likely to correctly classify the target condition? No    
Did the execution of the MAT include paired samples? No    
Were the reference standard results interpreted without knowledge of the results of the index tests? Unclear    
Does the case definition match the review question? Yes    
Is the execution of the test reported in such detail that reproduction is possible? Yes    
    High Low
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