Infecious detection Malaria PF PV Rapid Test Colloidal Gold with CE approved

Malaria PF PV Rapid Test Colloidal Gold  

Products Details

Malaria P.F/ P.V Rapid Test  Colloidal Gold

Production information
Model Number  Malaria PV PF Packing 25 Tests/ kit, 30kits/CTN
Name

Malaria PF PV Rapid Test Colloidal Gold 

Instrument  classification Class I
Features High sensitivity, Easy opeation Certificate CE/ ISO13485
Accuracy > 99% Shelf life Two Years
Methodology Colloidal Gold OEM/ODM service Avaliable
 
Summary Malaria is caused by single-celled microorganisms of the plasmodium group, it’s normally spread by bites of mosquitos, and it’s an infectious disease that affects lives and life safety of human beings and other animals. Patients infected with malaria normally will have fever, fatigue, vomiting, headache and other symptoms, and severe cases may lead to xanthoderma, seizure, coma and even death.  Malaria P.F/P.V Rapid Test can rapidly detect antigen to plasmodium falciparum histidine-rich proteins II and antigen to plasmodium vivax lactate dehydrogenase that exit in human whole blood sample.Intend Use This kit is applicable to in vitro qualitative detection of antigen to plasmodium falciparum histidine-rich proteins II (HRPII) and antigen to plasmodium vivax lactate dehydrogenase (pvLDH) in human whole blood sample, and it’s used for auxiliary diagnosis of plasmodium falciparum (pf) and plasmodium vivax (pv) infection. This kit only provides detection result of antigen to plasmodium falciparum histidine-rich proteinsII and antigen to plasmodium vivax lactate dehydrogenase, and results obtained shall be used in combination with other clinical information for analysis. It must only be used by healthcare professional.The WIZ BIOTECH reagent test will be compared with the control reagent:
Reference Sensitivity  Specificity 
Well-know reagent P.F.98.64%,PV:99.32% 99.48%
  Sensitivity:P.F.98.64%,PV.:99.32% Specificity:99.48%Test procedure
 1 Restore sample and kit to room temperature, take test device out of the sealed pouch, and lie it on horizontal bench.
 2 Pipette 1 drop (around 5μL) of whole blood sample into the well of test device (‘S’ well) vertically and slowly by the disposable pipette provided.
 3 Turn sample diluent upside down, discard first two drops of sample diluent, add 3-4 drops of bubble-free sample diluent dropwise to the well of test device (‘D’ well) vertically and slowly, and start counting time
 4 Result shall be interpreted within 15~ 20 minutes, and detection result is invalid after 20 minutes.
Note: each sample shall be pipetted by clean disposable pipette to avoid cross contamination.  Feature: •  High sensitive •  result reading in 15 minutes •  Easy operation • Factory direct price • Do not need extra machine for result reading  

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