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. |
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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. |
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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. |
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Target condition and reference standard(s) |
Target condition(s):P falciparum and P vivax Reference standard(s): microscopy corrected by PCR Microscopy details:
PCR details:
Blinding: The results of the RDT were determined and kept seperate so it does not interfere with the reference standard results. |
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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. |
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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? | 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 |