SD BIOSENSOR Malaria P.f/P.v | 09MAL20D Ag Test

Ag Test is a fast and membrane primarily based totally immmunochromatography for the qualitative detection of Plasmodium falciparum (P. falciparum) particular Histidine Rich Protein 2 (HRP-2) and Plasmodium vivax particular Plasmodium lactate dehydrogenase (pLDH) in human PQDx 0348-117-00 WHO PQ Public Report May 2021, model 2.0 capillary and venous entire blood specimens of sufferers suspected of getting malaria.

STANDARD Q Malaria P.f/P.v Ag Test

It is meant to be utilized by skilled healthcare or laboratory specialists or different healthcare people who’ve acquired suitable training. This product may be utilized by skilled lay carriers running in factor of-care settings in resource-confined lower- and middle-earnings countries. This product isn’t always meant for selftesting.” Assay description According to the declare of assay description from SD Biosensor, Inc, “STANDARD Q Malaria P.f/P.v Ag Test includes two-pre-covered strains, “P.f” (P. falciparum line), “P.v” (P. vivax) as check strains and “C” as manage line at the floor of the nitrocellulose membrane. The check strains and manage line withinside the end result window of the check tool aren’t seen earlier than making use of any specimens.

  • Monoclonal anti-P. falciparum HRP-2 is covered at the P.f check line area, monoclonal anti-Malaria P. vivax LDH is covered at the P.v check line area and monoclonal anti-bird IgY is covered at the manage line area.
  • During the check, the P. falciparum particular HRP-2 and/or P. vivax particular pLDH withinside the specimen react to the gold-conjugated monoclonal anti-Malaria HRP-2 and/or gold-conjugated monoclonal anti-Malaria P. vivax LDH and then bind to them respectively.
  • Any P. falciparum particular HRP-2 antigen-antibody gold particle complicated and/or P. vivax particular pLDH antigen-antibody gold particle complicated additionally migrate with the buffer and are immobilized through monoclonal anti-P. falciparum HRP-2 and/or monoclonal anti-Malaria P. vivax LDH at the 2 character check strains to formation of violet check coloured band(s) which confirms a nice end result.
  • Absence of this violet coloured bands shows a terrible end result. The manage line is used for procedural manage, and need to always seem if the check system is accomplished well and the check reagents of the manage line are working”.

Items required however now no longer provided

  • Anti-coagulant tube containing heparin, EDTA or sodium citrate for series of venous entire blood
  • Micropipette and tip
  • Timer
  • PPE (Personal Protective Equipment)
  • Pen/pencil
  • Extra lancets and alcohol swabs
  • Biosafety sharps container
  • Biohazard container
  • Sterile gauze Warnings/limitations Refer to contemporary model of manufacturer’s commands for use.

Prioritization for prequalification Based

at the hooked up eligibility criteria, STANDARD Q Malaria P.f/P.v Ag Test changed into given precedence for WHO prequalification evaluation Dossier evaluation SD Biosensor, Inc submitted a product file for STANDARD Q Malaria P.f/P.v Ag Test as in line with the “Instructions for compilation of a product file” (PQDx_018 model 3). The records (statistics and documentation) submitted withinside the product file changed into reviewed through WHO team of workers and outside technical experts (assessors) appointed through WHO. The manufacturer’s responses to the nonconformities observed at some stage in file screening and evaluation findings had been normal on 29 October 2018. Commitment for prequalification SD Biosensor, Inc commits to put up a timeline for the submission of the transport balance very last file through May 2021. WHO will follow-up on implementation of this dedication at the subsequent re-inspection or date assigned withinside the dedication assessment letter. Based at the product file screening and evaluation findings, the product file for STANDARD Q Malaria P.f/P.v Ag product call meets WHO prequalification requirement An inspection of SD Biosensor Inc., positioned at 74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, Republic of Korea changed into carried out among 17-19 April 2019. At the time of thinking about the product software for Prequalification, the Manufacturer of the product had a well-hooked up quality control device and production practices in vicinity that could assist the manufacture of the made from constant quality.

Routine inspections of the Manufacturer could be carried out with copies of those WHO Public Inspection Reports (WHOPIRs) published at the WHO Prequalification net web page as in line with Resolution WHA57.14 of the World Health Assembly. To observe that a WHOPIR displays the records at the maximum contemporary inspection accomplished at a production web website online for in vitro diagnostic merchandise and offers a precis of the inspection findings.

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Product overall performance evaluation STANDARD Q Malaria P.f/P.v Ag Test1 changed into protected withinside the 8th spherical of WHO product trying out of RDTs for malaria antigen detection, which changed into finished in 2018. The product changed into evaluated towards a Plasmodium falciparum cultured line panel, P. falciparum wild-kind parasite panel, P. vivax wild-kind parasite panel and a terrible panel. Thermal balance changed into assessed after 2 months of garage at improved temperature and humidity, and a descriptive ease of use evaluation changed into recorded.

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