Skip to main content
. 2020 Nov 4;2020(11):CD013218. doi: 10.1002/14651858.CD013218.pub2

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
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
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
Target condition and reference standard(s) Target condition(s):P falciparum and P vivax
Reference standard(s): PCR and microscopy
Microscopy details:
  • 200 high powered fields

  • Two microscopists independently examined each microscopic slide; one of which was employed by the study and the other was posted at Matiranga UHC.

  • Slide considered positive only when the two microscopists were in agreement. Discrepancies were resolved by a third microscopist.


PCR details:
  • Did not report who performed PCR.

  • Detection limit of 5‐10 parasites/μL.


Blinding: not reported
Flow and timing Appropriate interval between index test and reference standard: one blood sample taken from each patient.
Invalid test results: None reported.
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