Summary of findings 1. Summary of findings table for RDTs for diagnosing P vivax malaria.
| Population: people presenting with symptoms of uncomplicated malaria | ||||||
| Prior testing: none | ||||||
| Setting: ambulatory healthcare settings in P vivax endemic areas | ||||||
| Index tests: immunochromatography‐based rapid diagnostic tests (RDTs) for P vivax malaria that meet the WHO malaria RDT performance criteria (WHO 2017b) | ||||||
| Reference standards: conventional microscopy, polymerase chain reaction (PCR) | ||||||
| Target condition:P vivax malaria | ||||||
| Importance: accurate and fast diagnosis of P vivax from other malaria species allows appropriate treatment to be provided quickly | ||||||
| Study design: retrospective or prospective cohort or cross‐sectional | ||||||
| Findings: 10 studies of six different RDT brands (CareStart Malaria Pf/Pv Combo test, Falcivax Device Rapid test, Immuno‐Rapid Malaria Pf/Pv test, SD Bioline Malaria Ag Pf/Pv test, OnSite Pf/Pv test and Test Malaria Pf/Pv rapid test) for P vivax malaria were included. Only two brands (CareStart Malaria Pf/Pv Combo test and Falcivax Device Rapid test) were evaluated against the same reference standard by more than one study. | ||||||
| Limitations: a small number of studies were included in the analyses and meta‐analyses were only possible for two RDT brands. Studies often did not report how patients were selected, the blinding of the RDT results to the reference standard and the storage conditions and lot testing of RDTs. | ||||||
| Outcome | № of studies | № of patients | Numbers in a cohort of 1000 patients tested (95% CI)a | Certainty of the evidence (GRADE)b | ||
| Prevalence of 0.5% | Prevalence of 5% | Prevalence of 20% | ||||
| Test (reference standard): CareStart Malaria Pf/Pv Combo test (microscopy), pooled sensitivity (95% CI) = 99% (94% to 100%) and pooled specificity (95% CI) = 99% (99% to 100%), positive likelihood ratio (95% CI) = 141.09 (68.18 to 292.00) and negative likelihood ratio (95% CI) = 0.01 (0.00 to 0.06) | ||||||
|
True positives (patients with P vivax malaria) |
4 | 251 | 5 (5 to 10) | 50 (47 to 50) | 198 (188 to 200) | ⊕⊕⊕⊝ MODERATE1 |
|
False negatives (patients incorrectly classified as not having P vivax malaria) |
0 (0 to 0) | 0 (0 to 3) | 2 (0 to 12) | |||
|
True negatives (patients without P vivax malaria) |
2147 | 985 (980 to 995) | 941 (941 to 950) | 792 (792 to 800) | ⊕⊕⊕⊝ MODERATE1 |
|
| False positives (patients incorrectly classified as having P vivax malaria) | 10 (0 to 10) | 9 (0 to 9) | 8 (0 to 8) | |||
| Test (reference standard): Falcivax Device Rapid test (microscopy), pooled sensitivity (95% CI) = 77% (53% to 91%) and pooled specificity (95% CI) = 99% (98% to 100%), positive likelihood ratio (95% CI) = 120.31 (43.10 to 335.87) and negative likelihood ratio (95% CI) = 0.23 (0.10 to 0.53) | ||||||
|
True positives (patients with P vivax malaria) |
2 | 89 | 4 (3 to 5) | 39 (27 to 46) | 154 (106 to 182) | ⊕⊕⊝⊝ LOW1,2 |
|
False negatives (patients incorrectly classified as not having P vivax malaria) |
1 (0 to 2) | 11 (4 to 23) | 46 (18 to 94) | |||
|
True negatives (patients without P vivax malaria) |
621 | 985 (975 to 995) | 941 (931 to 950) | 792 (784 to 800) | ⊕⊕⊕⊝ MODERATE1 |
|
| False positives (patients incorrectly classified as having P vivax malaria) | 10 (0 to 20) | 9 (0 to 19) | 8 (0 to 16) | |||
aMedian values were chosen from ranges of prevalence considered to be moderate, low, and very low transmission settings for P vivax (WHO 2017c). bMethods are lacking to assess the determinants and extent of publication bias for diagnostic studies. However, in this table, we considered publication bias ‘undetected'. 1Downgraded for risk of bias by one. 2Downgraded for imprecision by two due to wide confidence intervals.
GRADE certainty of the evidence.
High: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.