Anti-HRP2 and Anti-pLDH Antibodies for Falciparum and Vivax Malaria Rapid Diagnostic Tests
The Sekbio Malaria Pf/Pv Antibody Pair consists of two matched antibody pairs targeting the two primary malaria diagnostic antigens: HRP2 (Histidine-Rich Protein 2) for P. falciparum-specific detection, and pLDH (Plasmodium Lactate Dehydrogenase) for pan-malaria and P. vivax-specific detection.
Designed for integration into dual-line lateral flow rapid diagnostic tests (RDTs) following the WHO recommended two-antigen format (Pf-specific + pan-species) — meeting the performance criteria outlined in WHO Malaria RDT Product Testing guidelines for endemic-country deployment.
Anti-HRP2 pair achieves >98% sensitivity at 200 parasites/µL for P. falciparum detection — meeting and exceeding WHO Criterion 1 (>95% sensitivity for Pf mono-infections at 200 p/µL).
Pan-pLDH antibody detects all four Plasmodium species. Pv-specific pLDH variant enables differentiation of P. vivax from P. falciparum — critical for treatment selection (chloroquine for Pv, artemisinin for Pf).
Thermostable formulation validated for stability under high-temperature, high-humidity conditions (40°C/75% RH) — meeting WHO requirements for malaria RDT deployment in sub-Saharan Africa and SE Asia.
Single fingerstick whole blood sample — no venipuncture, centrifugation, or cold chain for sample processing. Designed for deployment at community health worker and village clinic level.
Configured for two-test-line RDT (Pf line + pan/Pv line) plus control line — the WHO-recommended format providing maximum information per test for Pf/Pv co-endemic regions.
Antibody pair designed to meet WHO Malaria RDT Product Testing lot testing criteria — supporting WHO prequalification submissions and national malaria program procurement requirements.
| WHO Criterion | Requirement | Sekbio Performance |
|---|---|---|
| Pf sensitivity at 200 p/µL (HRP2) | >95% | >98% ✓ |
| Pv sensitivity at 200 p/µL (pLDH) | >75% | >95% ✓ |
| Specificity (healthy, other febrile) | >90% | >99% ✓ |
| HRP2 false positive (non-malarial) | <10% | <1% ✓ |
| Performance data from laboratory and field validation studies. Full data package available on request. | ||
| Condition | HRP2 Line | pLDH Line |
|---|---|---|
| Dengue fever | Negative ✓ | Negative ✓ |
| Typhoid fever | Negative ✓ | Negative ✓ |
| Rheumatoid factor | Negative ✓ | Negative ✓ |
| Healthy blood donors | Negative ✓ | Negative ✓ |
HRP2 anti-Pf antibody for the Pf test line in WHO-format malaria RDTs deployed in sub-Saharan Africa — where P. falciparum is responsible for ~95% of malaria burden and deaths.
Dual-antigen Pf+pan/Pv RDT for SE Asia where Pf and Pv co-circulate. Pv-specific pLDH detection enables treatment differentiation critical for preventing relapse (radical cure with primaquine for Pv).
Fingerstick whole blood format suitable for community-level malaria case management in remote areas. No laboratory infrastructure required — supporting WHO universal access to malaria diagnosis goals.
Anti-HRP2 and anti-pLDH antibody pairs supplied as separate OEM raw materials for malaria RDT manufacturers. Thermostability data and full validation package available for WHO product testing submissions.
Technical datasheets, performance data, and OEM supply details available on request.