Subtropical Area Hotsales Whole Blood Malaria P.f/P.v Rapid Diagnostic Tests

【INTENDED USE】

This Malaria P.f/P.v Rapid Test Kit is a rapid test for the qualitative detection of Malaria Antigen P.f or/and P.v in human venous and capillary whole blood.

【INTRODUCTION】

This Malaria Antigen P.f/P.v Rapid Test Kit is a lateral flow immunochromatographic assays for qualitatively detection of Malaria Antigen P.f or/and P.v in human venous and capillary whole blood of individuals with signs and symptoms of malarial infection. The test targets the histidine-rich protein II (HRPII) antigen specific to Plasmodium falciparum (P.f.) and a p.v-malarial antigen, common to P. vivax (P.v.).It is intended to aid in the rapid diagnosis of human malaria infections and to aid in the differential diagnosis of Plasmodium falciparum (P.f.) infections from P. vivax (P.v.) infections

【CONTENTS】

• Rapid Test. • Buffer • Disposable pipettes • Instruction for use.

【STORAGE AND STABILITY】

• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.

• The test must remain in the sealed pouch until use.

• Keep away from direct sunlight, moisture and heat.

• Do not freeze.

• Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.

【OPERATION】 Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1. Remove the test device from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.

2. Place the test device on a clean and level surface. Transfer the specimen by a pipette or a disposable specimen pipette:  To use a Pipette: Transfer 5 L of whole blood to Well-S (S) of the test device, then add 3~4 full drops of buffer to Well-B (B), and start the timer. (See illustration ① below). Avoid trapping air bubbles in S.  To use a Disposable Specimen Pipette: Hold the pipette vertically; draw the specimen up to the Fill Line as shown in illustration ① below. Transfer the specimen to S of the test device, then add 3~4 full drops of buffer to B and start the timer. Avoid trapping air bubbles in S.

3. Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.

【INTERPRETATION OF RESULTS】

Positive (+) Malaria P.f Positive: Both Pf test region (Pf) and control region appear color line.

Malaria P.v Positive: Both Pv test region (Pv) and control region appear color line.

Malaria P.f and P.v Positive: Both test region (Pf and Pv) and control region appear color line.

Negative (-) Only one colored band appears, in the control region (C). No colored band appears in the test region (Pf and Pv).

Invalid Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor

【PERFORMANCE CHARACTERISTICS】

For Pan: Relative Sensitivity: 99.37%

For P.f: Relative

Sensitivity: 98.15%

Relative Specificity: 99.08%

Accuracy: 99.07%

【TEST LIMITATIONS】

The test is limited to the detection of P.falciparum specific histidine richprotein-2(P.f HRP-2) or/and P.v specific pLDH . Although the test is veryaccurateindetecting antibodies to Malaria Antigen, a low incidence of false results canoccur.Other clinically available test are required if questionable results are obtained.Aswith all diagnostic tests, a definitive clinical diagnosis should not be basedontheresults of a single test, but should only be made by the physician after all clinicaland laboratory findings have been evaluated.

【QUALITY CONTROL】

A procedural control is included in the test. A line appearing in the Control region(C) is considered an internal procedural control. It confirms sufficient specimenvolume, adequate membrane wicking and correct procedural technique. Control standards are not supplied with this kit. However, it is recommendedthatpositive and negative controls be tested as good laboratory practice toconfirmthetest procedure and to verify proper test performance. Quality control shouldberunwith each new lot, and every 30 days to check storage stability. Positiveandnegative control should give the expected results.