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SD Biosensor – Rapid Diagnostic Test: Standard Q Malaria P.f/Pan Ag Test

Last updated: 18th December, 2023

Products are for Professional/Laboratory use only

SD Biosensor Standard Q Rapid Diagnostic Malaria P.f/Pan Ag Test for IVD use.

STANDARD Q Malaria P.f/Pan Ag Test

  • WHO Pre-Qualified & included on the ARTG for IVD use.
  • Distinguishes the infection between P.falciparum and others.
  • A cost-effective and fast malaria screening test.
  • Fast test result in 15 minutes.
  • Sampler (inverted cup) provided for easy specimen collection.
  • Low volume of 5 μl whole blood required for testing.
  • Room temperature storage of 2-40°C.
  • Optimized for on-site diagnosis and practical for large scale testing.



STANDARD Q Malaria P.F/Pan Ag Test
Target antigens Histidine-Rich Protein II (HRP-II) of Plasmodium falciparum and plasmodium actate dehydrogenase (pLDH) of Plasmodium(P.f, P.v, P.m, P.o) species
Specimen type Whole blood
Specimen Volume 5 μl
Regulatory WHO PQ, CE, TGA
Testing time 15 ~ 30 minutes
Storage temperature 2 ~ 40℃ (36 ~ 104℉)
Shelf life 24 months



Clinical Evaluation

As part of WHO PQ clinical evaluation data, the evaluation took place in 4 sites (Cambodia, India, Malawia, Zambia) and the summary of the clinical performance is as below.

Product Specimen Type Malaria Type Sensitivity Specificity
STANDARD Q Malaria P.f/Pan Ag Test Venous WB P.f 99.58%
(95% CI: 98.50-99.95%)
(95% CI: 99.63-100%)
Pan 100%
(95% CI: 97.18-100%)
(95% CI: 99.63-100%)
Capillary WB P.f 99.68%
(95% CI: 98.23-99.99%)
(95% CI: 98.54-100%)
Pan 100%
(95% CI: 88.78-100%)
(95% CI: 98.54-100%)




CAT No Product Type Tests / Kit
09MAL30D STANDARD Q Malaria P.f/Pan Ag Test Device 25T / Kit
10MALC10 STANDARD Malaria Ag Control (RUO) Control 10T / Kit

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