The Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit is a malaria test kit for the qualitative detection of malaria antigens in human whole blood. It detects histidine-rich protein 2 (HRP2) from Plasmodium falciparum and plasmodium lactate dehydrogenase (pLDH) associated with Pf and Pan malaria.

In this malaria Pan/Pf antigen test, Pan represents Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale and Plasmodium malariae. The combined format helps distinguish a Pf-specific HRP2 result from a Pan pLDH result as part of a professional malaria diagnostic workup.

• Pf/Pan antigen detection: Detects Pf HRP2 and Pan pLDH targets in one malaria rapid diagnostic test.

• Whole-blood testing: Designed for human whole blood specimens.

• Fast workflow: Delivers results within 15 minutes using a three-step procedure.

• Built-in quality control: Includes a control mechanism to support result validity.

• Shelf life: 24 months

Target region: HRP2 of Pf, and pLDH of Pan

Clinical Sensitivity: 97.2% (Pf), 91.7% (Pan)

Clinical Specificity: 98.5% (Pf), 99.6% (Pan)

Storage temperature: 4℃-30℃

Transportation temperature: -20℃~45℃

Sample type: Human whole blood

The malaria RDT is designed for professional whole-blood testing when malaria infection is clinically suspected. Applications include:

• Rapid malaria assessment: Qualitative Pf/Pan antigen testing for individuals with signs and symptoms consistent with malaria infection.

• Pf and Pan differentiation support: Detection of Pf-specific HRP2 together with Pan pLDH to support laboratory or point-of-care interpretation within the intended use.

• Time-sensitive testing workflows: Use in settings that need a three-step malaria blood test with results within 15 minutes, subject to local procedures and professional interpretation.

CE-IVDR, NMPA, Anvisa