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Singuway Nucleic Acid Detection Kit
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Plasmodium falciparum

Description


  • Malaria is an acute febrile illness caused by Plasmodium parasites that are transmitted to people through the bites of infected female Anopheles mosquitoes. It is preventable and curable.
  • In 2020, there were an estimated 241 million cases of malaria worldwide.
  • The estimated number of malaria deaths stood at 627 000 in 2020.
  • The WHO African Region carries a disproportionately high share of the global malaria burden. In 2020, the region was home to 95% of malaria cases and 96% of malaria deaths. Children under 5 accounted for about 80% of all malaria deaths in the Region.
  • There are 5 parasite species that cause malaria in humans, and 2 of these species – P. falciparum and P. vivax – pose the greatest threat. P. falciparum is the deadliest malaria parasite and the most prevalent on the African continent. P. vivax is the dominant malaria parasite in most countries outside of sub-Saharan Africa.



Intended Use

The Detection Kit for Plasmodium Falciparum is used for in vitro detection of plasmodium and distinguishment of Plasmodium falciparum (P. falciparum) in human venous whole blood. Plasmodium is a genus of unicellular eukaryotes that are obligate parasites of vertebrates and insects. There are five species of malaria parasite that regularly infect humans, including: P. vivax, P. falciparum, P. malariae, and P. ovale. P. falciparum is by far the most lethal in humans, resulting in hundreds of thousands of deaths per year.


Features


  • High sensitivity, 500copies/mL
  • High specificity, using specific probes for target sequence identification
  • Good compatibility for simultaneous detection of other Plasmodium species and typing of P. falciparum
  • PCR buffer and polyase mix contain Uracil-DNA glycosylase (UDG) eliminating carryover contamination
  • Ready-to-use kit simplifies workflow & compatible with a wide range of real-time PCR devices
  • Rapid detection, the amplification can be completed within 30mins



Technical Specifications

REF No.

PF001

Regulatory Status

CE IVD

Packing Specifications

48 Tests/ Kit, 96 Tests/Kit

Technology

Real-time PCR

Type Of Analysis

Qualitative

Sample Type

Serum, Plasma, Fresh Whole Blood, Frozen Preserved Whole Blood

Reaction Volume

30μL

Species

Plasmodium Falciparum

Analytical Sensitivity

500copies/mL

Precision

CV≤5%

Storage

-20℃±5℃in dark for 12 months

Main Components

PCR Buffer, Polyase Mix, Negative Control, Positive Control

Validated Extraction Method

Whole blood extraction kit (Singuway REF: MTQB064/MTQB096) is recommended.

Instruments

A real-time PCR instrument containing at least three colors fluorescence channels, such as Singuway Singu9600, Bio-RadCFX96, ABI 7500, Thermo Fisher StepOnePlus.

Required Detection Channels

FAM, HEX/VIC, ROX

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