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. 2020 Nov 4;2020(11):CD013218. doi: 10.1002/14651858.CD013218.pub2

Mendoza 2013.

Study characteristics
Patient Sampling Study design: retrospective cross‐sectional study
Recruitment: consecutive
Study period: November 16 to December 2, 2010 in Córdoba and from June 14 to 25, 2011 in Chocó, Colomba
Population: 383 patients who attended one of three clinics with microscopy for diagnosis of malaria.
Inclusion and exclusion criteria: patient was considered as a probable case of malaria and at least 6 years of age (with consent), were included. Probable case defined as patients presenting with current or recent fever within 72 hours, who came from an endemic area in the last 15 days and who may or may not have an epidemiological relationship with diagnosed cases. The study excluded patients who did not consent to participation, lack of diligence of the clinical epidemiological record or who presented with symptoms of complicated malaria.
Patient characteristics and setting Sex: 52.5% male, 47.5% female
Age range: 6 and 92 years
Setting: 233 patients came from Córdoba, of which 121 were from Tierralta and 112 from Puerto Libertador. The remaining 150 patients were recruited in the department of Chocó, in the municipality of Quibdo.
Malaria transmission: The study reported Córdoba had the highest prevalence of P vivax, unclear for Chocó.
Other patient characteristics: 7.8% of the patients received treatment for malaria in the previous month of recruitment.
Index tests RDT brand(s): SD Bioline Malaria Ag Pf/Pv test (Standard Diagnostics Inc)
Batch number: not reported
Lot testing: not reported
Storage conditions: reported manufacturer's instructions were followed (1ºC‐40ºC)
Blinding: The results of the RDT were determined and kept separate so it does not interfere with the reference standard results.
Target condition and reference standard(s) Target condition(s):P falciparum and P vivax
Reference standard(s): microscopy corrected by PCR
Microscopy details:
  • Number of high powered fields not reported.

  • Blood films were examined by two experienced readers independently and blindly.

  • Discordant results were checked by a third reader.


PCR details:
  • Did not report who performed PCR.

  • Detection limit not reported.

  • When there were discordant results between microscopy and PCR, the result of the PCR was taken, except in those in which the thick drop showed parasitic forms and the PCR was negative.


Blinding: The results of the RDT were determined and kept seperate so it does not interfere with the reference standard results.
Flow and timing Appropriate interval between index test and reference standard: Multiple blood samples were taken at the same time for 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? Yes    
Was a case‐control design avoided? Yes    
Did the study avoid inappropriate exclusions? Yes    
Could the selection of patients have introduced bias?   Low 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? Yes    
If a threshold was used, was it pre‐specified? Yes    
Could the conduct or interpretation of the index test have introduced bias?   Low 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? Yes    
Could the reference standard, its conduct, or its interpretation have introduced bias?   Low 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