Ultrasensitive malaria rapid diagnostic tests have higher sensitivity than conventional malaria rapid diagnostic tests

Afbeelding

Objectives:
To overcome the limitations of conventional malaria rapid diagnostic tests (cRDTs) in diagnosing malaria in patients with low parasitaemia, ultrasensitive malaria rapid diagnostic tests (uRDTs) have recently been developed, with promising results under laboratory conditions. Therefore, this review article has been conducted.

What is the overall sensitivity and specificity of newly developed ultrasensitive Plasmodium falciparum malaria RDT (Alere™ Ultra-sensitive Malaria Ag P. falciparum RDT (uRDT)), when compared with the conventional malaria rapid diagnostic tests (cRDT) conducted in the same field conditions?

Study design:
This review article included 14 cross sectional studies with 15 data sets.
Studies were published between 2018 and 2021, with 9 out of 14 conducted in sub-Saharan African countries.
The mean/median age of the study population ranged from 4 to 36 years as reported by 7 studies.
The risk of bias in studies included in the review ranged from low to moderate.

Results and conclusions:
The investigators found the overall sensitivity of the Alere™ ultra-sensitive Malaria Ag P. falciparum RDT regardless of the reference test and the clinical presentation of participants, was 55.5% [95% CI = 45.5 to 65.0], while the sensitivity regardless of the reference test and the clinical presentation of participants, was 42.9% [95% CI = 31.5 to 55.2] for the cRDT performed in the same field conditions.

The investigators found when PCR was used as reference test, the sensitivity of uRDT was 60.4% [95% CI = 50.8 to 69.2], while the sensitivity was 49.4% [95% CI = 38.2 to 60.6] for the cRDT.

The investigators found the pooled specificity of uRDT regardless of the reference test and the clinical presentation of participants was 98.6% [95% CI = 97.1 to 99.4] and the pooled specificity of cRDT regardless of the reference test and the clinical presentation of participants was 99.3% [95% CI = 98.1 to 99.7].

The investigators found when PCR was used as reference test the specificity of uRDT and cRDT was 97.5% [95% CI = 94.1 to 98.9] and 98.2% [95% CI = 95.5 to 99.3].

The investigators found regardless of the reference test used, the sensitivity of Alere™ Ultra-sensitive Malaria Ag P. falciparum RDT in symptomatic patients was 72.1% [95% CI = 67.4 to 76.4], while sensitivity of cRDT was 67.4% [95% CI = 57.6 to 75.9].

The investigators concluded that Alere™ Ultra-sensitive Malaria Ag P. falciparum RDT (uRDT) compared to conventional malaria rapid diagnostic tests (cRDT) performed in the same field conditions has higher sensitivity but lower specificity although the difference is not statistically significant.

Original title:
Assessing field performance of ultrasensitive rapid diagnostic tests for malaria: a systematic review and meta-analysis and Danwang C, Kirakoya-Samadoulougou F and Samadoulougou S.

Link:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8176703/

Additional information of El Mondo:
Find more information/studies on RCTs/cohort/significantly/review article, malaria and food fortification/malnutrition right here.

In a diagnostic test, sensitivity is a measure of how well a test can identify true positives.
In a diagnostic test, specificity is a measure of how well a test can identify true negatives.