PreciMALARIA P.F/P.V
(Rapid Malaria ANTIGEN TEST)

EXPLANATION OF THE TEST
The preci MALARIA P.f/P.v Rapid Test is a chromatographic immunoassay for qualitative of Malaria Parasite infection in human blood sample. The test detects Antigen of Malarial Parasites (P.f./P.v.) in human blood sample. Malarial Parasite Antigen, LDH (Lactate dehydrogenase, in human blood sample are allowed to react with the Anti-LDH and Anti-aldolase monoclonal antibody-coupled gold conjugate followed by reaction with, anti-LDH and or Anti-aldolase monoclonal antibody immobilize at T1 & T2 as test lines. When the human blood sample in infected with malarial parasite, a pink/purple visible line appears at the regions on the membrane. Appearance of another line (Control) validates the procedure. The Malarigen P.f/P.v Rapid Test can also discriminate between P. falciparum and P.vivax.

MATERIAL PROVIDED
PreciMALARIA P.F./P.V. Raped Test kit contain the following items.
1. Malaria P.f/P.v. Antibody Coated Dipsticks
2. Buffer vial & Droppers
3. Micro wells & Holder
4. Pack Insert

STORAGE AND STABILITY
The PreciMALARIA P.F./P.V. Rapid Test kit stored between 2-30 °C (40-86 °F). The PreciMALARIA P.F./P.V. Rapid Test will remain stable untill the expiration date printed on the kit.
The test device is sensitive to humidity as well as to heat. So, it's very important to remove the required number of strips and then close the container immediately and tightly. Do not use kit after the expiry date.

SPECIMEN COLLECTION AND STORAGE
The test should be performed with venous blood collected in the sample tube containing anticoagulant.

OR

Freshly collected blood from the finger tip can be used as a sample.
For the short term storage, please keep the specimen at 2-8 °C.

TEST PROCEDURE

1. Place the desired number of micro wells in the holder & add 5 drops of the buffer in the micro wells.
2. Remove the test strip from the cannister and place it on clean flat surface. Take 10 ul of whole blood specimen from tube/finer prick with micro pipette/dropper provided in the kit. Touch the middle of the sample loading window of the test strip with tip of pipetta/tip of the dropper and dispense the specimen.

(When using dropper take the sample upto the fill the grey line as indicated in the diagram below)

3. Place the test strip in the microwell for 15 minutes. Read the results at 15 minutes. Don't interpret the result after 30 minutes.

INTERPRETATION OF RESULT

NEGATIVE: Pink/Purple line at C & T2

POSITIVE P. vivax: Pink/Purple line at C & T2
POSITIVE P. faciparum : Pink / Purple line at C, T1 & T2

Note: Pink/Purple lines only at C&T1 also to be considered positive for P. falciparum.

INVALID : Control line does not appear, the test is invalid. In this case, pleases repeat the test, following the test procedure correctly.

PERFORMANCE CHARACTERISTICS

Specificity & Sensitivity

The Precision PreciMALARIA (P.f/P.v Antigen) Raped Test has been evaluated with positive and negative clinical samples tested by microscopic examination (Giemsa Staining) and PCR

Specificity

Sensitivity (P. falciparum)

Sensitivity (P.vivax)

LIMITATIONS OF THE TEST
PreciMALARIA P.f/P.v. Rapid Test is designed for primary screening. This kit can provided fast and easy way to get a result, but do not completely exclude the possibility of false positive or faise negative result caused by various factors. So refer to the result of this please make a final decision with clinical manifestation, other test result and doctor's view collectively.