Standard Q Malaria P.F/P.V Ag Rapid Kit

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STANDARD Q Malaria P.f Ag subjectively breaks down Plasmodium falciparum and Plasmodium vivax antigens in entire blood utilizing immunochromatography. The objective antigen is Histidine-Rich Protein II (HRP-II) of Plasmodium faciparum and plasmodium lactate dehydrogenase (pLDH) of Plasmadium vivax, and the screening test result can be acquired in somewhere around 15 minutes with its high awareness and particularity.

  • Recognize the contamination among P.falciparum and P.vivax
  • Enhanced nearby conclusion with the little symptomatic pack
  • Ready to understand positive/negative contaminations quick and precisely with a little blood (5µl)
  • Room temperature capacity.
  • Planned use

As per the case of expected use from SD Biosensor, Inc, “STANDARD Q Malaria P.f/P.v
Ag Test is a quick and film based immmunochromatography for the subjective identification of Plasmodium falciparum (P. falciparum) explicit Histidine Rich Protein 2 (HRP-2)also, Plasmodium vivax explicit Plasmodium lactate dehydrogenase (pLDH) in human fine and venous entire blood examples of patients associated with having intestinal sickness.

STANDARD Q Malaria P.f/P.v Ag Test is planned to be utilized via prepared medical services or
research facility experts or other medical services laborers who have gotten suitable preparation.
This item can be utilized via prepared lay suppliers working in mark of-care settings in
asset restricted lower-and center pay nations.

This item isn’t expected for selftesting.”Examine portrayal As indicated by the case of test portrayal from SD Biosensor, Inc, “STANDARD Q Malaria P.f/P.v Ag Test contains two-pre-covered lines, “P.f” (P. falciparum line), “P.v” (P. vivax) as
test lines and “C” as control line on the outer layer of the nitrocellulose film. The test lines
furthermore, control line in the outcome window of the test gadget are not noticeable prior to applying any examples.

Monoclonal enemy of P. falciparum HRP-2 is covered on the P.f test line district,
monoclonal enemy of Malaria P. vivax LDH is covered on the P.v test line district and monoclonal
against chicken IgY is covered on the control line locale.

During the test, the P. falciparum explicit HRP-2 or potentially P. vivax explicit pLDH in the example respond to the gold-formed monoclonal hostile to Malaria HRP-2 or potentially gold-formed monoclonal enemy of Malaria P. vivax LDH and afterward tie to them individually.

Any P. falciparum explicit HRP-2 antigen-immune response gold molecule complex as well as P. vivax explicit pLDH antigen-counter acting agent gold molecule complex likewise move with the cushion and are immobilized by monoclonal enemy of P. falciparum HRP-2 or potentially monoclonal enemy of Malaria P. vivax LDH at the two individual test lines to arrangement of violet test shaded band(s) which affirms a positive outcome.

Nonappearance of this violet shaded groups shows an adverse outcome. The control line is utilized for procedural control, and ought to continuously show up assuming that the test system is performed appropriately and the test reagents of the control line are working”.

Things required yet not gave

• Hostile to coagulant tube containing heparin, EDTA or sodium citrate for assortment of
venous entire blood
• Micropipette and tip
• Clock
• PPE (Personal Protective Equipment)
• Pen/pencil
• Additional lancets and liquor swabs
• Biosafety sharps compartment
• Biohazard compartment
• Sterile bandage

Capacity

The test pack ought to be put away at 2-40°C.
Timeframe of realistic usability upon fabricate
two years.
Admonitions/impediments
Allude to current adaptation of maker’s guidelines for use.
Prioritization for prequalification
In light of the laid out qualification models, STANDARD Q Malaria P.f/P.v Ag Test was
given need for WHO prequalification appraisal

SD Biosensor, Inc presented an item dossier for STANDARD Q Malaria P.f/P.v Ag Test as
per the “Directions for arrangement of an item dossier” (PQDx_018 adaptation 3). The
data (information and documentation) submitted in the item dossier was looked into by
WHO staff and outside specialized specialists (assessors) designated by WHO.
The producer’s reactions to the dissentions found during dossier screening and
evaluation discoveries were acknowledged on 29 October 2018.

Responsibility for prequalification

SD Biosensor, Inc resolves to present a timetable for the accommodation of the delivery steadiness
last report by May 2021. WHO will circle back to execution of this responsibility at the
next re-investigation or date relegated in the responsibility survey letter.
In view of the item dossier screening and evaluation discoveries, the item dossier for
STANDARD Q Malaria P.f/P.v Ag item name meets WHO prequalification prerequisites.

Fabricating site examination.

A review of SD Biosensor Inc., situated at 74, Osongsaengmyeong 4-ro, Osong-eup,
Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, Republic of Korea was directed
between 17-19 April 2019. At the hour of considering the item application for
Prequalification, the Manufacturer of the item had a deeply grounded quality
the board framework and assembling rehearses set up that would uphold the
assembling of the result of predictable quality. Routine examinations of the Manufacturer
will be led with duplicates of these WHO Public Inspection Reports (WHOPIRs) distributed
on the WHO Prequalification page according to Resolution WHA57.14 of the World Health
Gathering. To take note of that a WHOPIR mirrors the data on the latest examination
performed at an assembling site for in vitro analytic items and gives a synopsis of the assessment discoveries.

Item execution assessment

STANDARD Q Malaria P.f/P.v Ag Test1 was remembered for the eighth round of WHO item
testing of RDTs for intestinal sickness antigen identification, which was finished in 2018. The item
was thought about in contrast to a Plasmodium falciparum refined line board, P. falciparum wild-type
parasite board, P. vivax wild-type parasite board and a negative board. Warm strength was
evaluated following 2 months of capacity at raised temperature and mugginess, and a graphic
convenience appraisal was recorded.

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In view of the showed P. falciparum board discovery score (85.0% at 200 parasites/µl),
P. vivax board discovery score (100 percent at 200 parasites/µl), bogus positive rates (0% for clean
negatives, 0.5% for P. falciparum at 200 parasites/µl, 0% for P. vivax at 200 parasites/µl, 0.5%
for P. falciparum at 2000 parasites/µl, 0% for P. vivax at 2000/µl) and invalid rate (0%),
STANDARD Q Malaria P.f/P.v Ag Test meets the present research center assessment necessities for prequalification.

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