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 |
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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 |
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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 |
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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? | 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 |