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Wednesday, 25 June 2014 09:40

Malaria Pf_Pv Ag Rapid Test Kit

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Gentaur-malaria-rapid-test-kitMalaria 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. 1.      State-of-arts workmanships and severe lab testing processes; Product CE approved and quality system ISO13485 certified;
  2. 2.      Easy assay procedure and rapid results reading; High sensitivity and specificity;
  3. 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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