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MALARIA TEST
CE Certificate
Intended Use:
The Advanced Quality™ One Step Malaria(p.f.)Test is A Colloidal Gold Enhanced, Rapid Immunochromatographic Assay for testing, in vitro , the presence of Plasmodium falciparum malaria in blood. The test is an antigen-capture assay detecting presence of a specific soluble protein, histidine-rich protein II (PfHRP-II), which is present in, and released from, infected red blood cells. The assay is intended for use with whole blood and does not require additional instruments.
Features:
Format | Cassette |
Specimen | Whole Blood |
Specificity | 96.9% |
Sensitivity | 99.7% |
Shelf life | 2 years |
Storage | 2-30°C |
Reading Time | 15 -20 minutes |
Certification | CE Certificate |
Quality Guaranty | GMP & ISO 13485 |
Sample Collection and Storage:
Collect whole blood specimens following regular clinical laboratory procedures.
Storage: A specimen should be refrigerated if not used the same day of collection. 0.1% of sodium azide can be added to specimen as preservative without affecting the results of the assay.
Sample Collection for Finger Blood
To collect finger blood for the Malaria (Pf) Test, please follow the steps closely as following. 1. Choose either the middle or ring finger of your non-dominate hand for puncturing. Clean the finger with alcohol swab. 2. Puncture the finger with a sterile lancet. 3. Draw up blood into the plastic dropper. Redo the Procedure on another finger if necessary
Performance Characteristics:
The following data was generated by from previously frozen whole blood samples, and was determined by correlation to standard thick and thin smear microscopic examination with discrepants evaluated via PCR. Retrospective study results are summarized below:
The Malaria Test did not cross-react with any of the following species of malaria: P. malariae, P. ovale.
Malaria (pf) rapid test kits