Alam 2011.
Study characteristics | |||
Patient Sampling |
Study design: cross‐sectional study Recruitment: did not state consecutive or random sampling Study period: May 2009 to August 2010 Population: 338 febrile patients referred for microscopy to diagnose malaria diagnosis at a health facility Inclusion and exclusion criteria: not reported |
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Patient characteristics and setting |
Sex: 49.7% male, 50.3% female Age: median = 14 years, range 18 months to 82 years Setting: Matiranga Upazila Health Complex (UHC), in Matiranga Upazila (sub‐district) of Khagrachari district, south‐eastern part of Bangladesh Malaria transmission: perennial transmission of malaria with 2 peaks in pre‐monsoon (March to May) and post‐monsoon (September to November) periods |
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Index tests |
RDT brand(s): OnSite Pf/Pv test (CTK Biotech Inc, USA) and Falcivax Device Rapid test for malaria Pv/Pf (Zephyer Biomedicals, Goa) Batch number: not reported Lot testing: not reported Storage conditions: unclear, reported manufacturer's instructions were followed for use Blinding: not reported |
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Target condition and reference standard(s) |
Target condition(s):P falciparum and P vivax Reference standard(s): PCR and microscopy Microscopy details:
PCR details:
Blinding: not reported |
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Flow and timing |
Appropriate interval between index test and reference standard: one blood sample taken from each patient. Invalid test results: None reported. |
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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 case‐control design avoided? | Yes | ||
Did the study avoid inappropriate exclusions? | Unclear | ||
Could the selection of patients have introduced bias? | Unclear risk | ||
Are there concerns that the included patients and setting do not match the review question? | Low concern | ||
DOMAIN 2: Index Test (All tests) | |||
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 | ||
Could the conduct or interpretation of the index test have introduced bias? | Unclear risk | ||
Are there concerns that the index test, its conduct, or interpretation differ from the review question? | Unclear | ||
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? | Unclear | ||
Could the reference standard, its conduct, or its interpretation have introduced bias? | Unclear risk | ||
Are there concerns that the target condition as defined by the reference standard does not match the question? | Low concern | ||
DOMAIN 4: Flow and Timing | |||
Was there an appropriate interval between index test and reference standard? | Yes | ||
Did all patients receive the same reference standard? | Yes | ||
Were all patients included in the analysis? | Yes | ||
Could the patient flow have introduced bias? | Low risk |