GENTAUR Europe BVBA
Genprice Inc, Logistics
Serbia, 
Macedonia, 
Montenegro, 
Croatia: 
GENTAUR Romania
GENTAUR Greece 
Malaria Pf_Pv Ag Rapid Test Kit
Principle: Immunochromatographic assay
Cassette: 4mm
Kit Size: 25 Tests
Specimen: Whole Blood
CE Mark: Yes
Storage & Stability
Store at 2-30°C; Expiry period 24 months.
Features and advantages：
- 1. State-of-arts workmanships and severe lab testing processes; Product CE approved and quality system ISO13485 certified;
- 2. Easy assay procedure and rapid results reading; High sensitivity and specificity;
- 3. Full-aspects OEM service provided. Design according to customers unique requirements. Help improving customer’s brand value.
Intended Use
Malaria Pf/Pv Antigen Rapid Test is a lateral flow immunochromatographic assay for the qualitative simultaneous detection of Malaria P.falciparum specific histidine rich protein-2(Pf HRP-2) (for Pf) and the LDH (for Pv) in human whole blood as an aid in the diagnosis of Malaria infection. The test is recommended for professional use only. All results must be interpreted together with other clinical information available to the physicians.
Materials Provided
25 X Test Devices, each test cassette is packed in a foil pouch with a dropper (5ul) and a package of desiccant.
25 X Disposable blood lancet
25 X Alcohol pad
1 X Assay Buffer
1 X Instructions for Use
Ordering Information:
|
CAT # |
PRODUCT |
CE |
SPECIMEN |
SENSITIVITY |
ACCURACY |
FORMAT |
KIT SIZE |
|
RI742C |
Malaria Pf/Pv Ag |
√ |
Whole blood |
98.10%/96.86% |
99.03%/99.03% |
Cassette |
25 |
Result interpretation Time
The testing results should be read at 20 minutes after a specimen is applied to the sample well of the device.
Performance Characteristics
Sensitivity and specificity: Comparative testing with the traditional Microscopic examination method shows that Malaria Pf/Pv Antigen Test is capable to detect out malaria infection when in blood specimen plasmodium protozoa of Plasmodium falciparum or plasmodium protozoa of P. vivax reaches 50pcs/ul.
Clinical study between Malaria Pf/v Antigen Test and Microscopic examination method demonstrates that Malaria Pf/Pv Antigen Test has a sensitivity of 98.10% and specificity of 99.39% for P.falciparum.
Clinical study between Malaria Pf/Pv Antigen Test and Microscopic examination method demonstrates that Malaria Pf/Pv Antigen Test has a nn2xssensitivity of 96.86%, and specificity of 99.76% for P. vivax.
Precision: within-run and between-run precisions have been determined by testing 10 replicates of three specimens: a negative, a low positive and a strong positive. The agreement between the test results and the expected results were 100%.
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