Diagnostic accuracy of novel Biocredit species-specific LDH-based immunochromatographic assay for Plasmodium falciparum and Plasmodium vivax detection: a systematic review and meta-analysis.

backgroundSensitive, non-histidine-rich protein 2 (HRP2)-based rapid diagnostic tests (RDTs) are urgently required in regions where Plasmodium (P.) falciparum HRP2/3 gene deletions exceed 5%. The Biocredit Pf/Pv RDT, based on detecting distinct P. falciparum and P. vivax lactate dehydrogenase (LDH) isomers, holds potential. But diagnostic performances were inconsistent across studies. This systematic review and meta-analysis aimed to evaluate the Biocredit Pf/Pv RDT’s pooled sensitivity and specificity for diagnosing P. falciparum and P. vivax.

methodsPubMed, EMBASE, Google Scholar, and Scopus were searched up to July 27, 2025. Studies that reported sufficient data to calculate the sensitivity and specificity of the Biocredit Pf/Pv RDT were included. The studies’ methodological quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. RDT’s pooled sensitivity and specificity were calculated against microscopy and PCR using a random-effects bivariate model. Subgroup analysis was conducted, and publication bias was assessed using a funnel plot and Deeks’ test.

resultsA total of 19 datasets from eight studies were included, comprising 3923 participants. The sensitivity and specificity of Biocredit Pf/Pv RDT for studies ranged from 56% to 100% and 92% to 100%, respectively. Pooled sensitivity was 91% (95% CI, 77–97%) for P. falciparum and 96% (95% CI, 88–99%) for P. vivax. Pooled specificity was 99% (95% CI, 95–100%) for P. falciparum and 100% (95% CI, 96–100%) for P. vivax. There was significant heterogeneity in sensitivity among the included studies. Pooled sensitivity against microscopy was 95% (95% CI, 85–98%) for P. falciparum and 97% (95% CI, 85–100%) for P. vivax. Against PCR, the corresponding sensitivities were 81% (95% CI, 64–91%) and 90% (95% CI, 83–94%). Pooled sensitivity for P. falciparum was 94% (95% CI: 81–98%) in high transmission settings and 73% (95% CI: 61–83%) in moderate transmission areas.

conclusionsBiocredit Pf/Pv RDT demonstrated good sensitivity and high specificity for diagnosing P. falciparum and P. vivax infections in sub-Saharan Africa. The assay showed robust sensitivity for P. falciparum and P. vivax against microscopy, although it appears less sensitive for P. falciparum than for P. vivax when compared with PCR. The Biocredit Pf/Pv assay seems suitable for the diagnosis of P. vivax and P. falciparum in settings with prevalent HRP2 gene deletions, but its utility may be limited in elimination settings. Data on South East Asian patients are limited, and its effectiveness in asymptomatic malaria is unclear. Future research is warranted to address this gap.

trial registrationCRD42024505398.