Origin	China
Brand Name	GEMINOL

Malaria Plasmodium falciparum竊�alaria P.f.竊�
Rapid Test Cassette (Whole Blood)Package Insert
INTRODUCTION
The one step Cassette Style Malaria P.f. test is a rapid test based on the principle of immunoassay combined with conjugated colloid gold technology. The Malaria P.f. test((Whole Blood) is a diagnostic device to detect the presence of the P.f. antigen in whole blood.

TEST PROCEDURE
1��llow the test kit, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing. 2��emove the test kit from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour. 3��lace the test device on a clean and level surface. Transfer the specimen by a Disposable Specimen Dropper竊�r a Pipette竊�
To use a Hold the dropper vertically, draw the specimen up to the Fill
Line as shown in illustration below(approximately 10 μL). Transfer the
specimen to the specimen well (S) of the test device, then add 3 full
drops of buffer (approximately 120 μL) and start the timer. Avoid
trapping air bubbles in the specimen well (S).

4��ait for the red line(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

. POSITIVE*: In addition to a pink colored control (C) band, a Distinct pink colored band will also appear in the test (T) region. *Note(Weak Positive): Colored band appearing in control Region (C) together with a faint colored band in Test Region (T).

. Negative: Only one colored band appears on the control (C) region. No apparent band on the test (T) region.

. Invalid: A total absence of color in both regions is an indication of procedure error and/or the test reagent has deteriorated.

STORAGE AND STABILITY
The test kit can be stored at temperatures from 4 ��to 30 ��in the sealed pouch up to date of expiration . The test kit should be kept away from direct sunlight and moisture .Do not freeze the test kit.

PRECAUTION
. For whole blood specimen use only. Do not use other specimens.

. Do not eat, drink or smoke in the area where the specimens or kits are handled.

. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.

. For professional in vitro diagnostic use only. Do not use after expiration date.