【INTENDED USE】
The Malaria P.f/Pan Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of circulating antigens of Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, Plasmodium malariae in whole blood.
【CONTENTS】
• Rapid Test.
• Buffer
• Disposable pipettes
• Instruction for use.
【CONTENTS】
• Rapid Test.
• Buffer
• Disposable pipettes
• Instruction for use.
【WARNINGS AND PRECAUTIONS】
• Immunoassay for in vitro diagnostic use only.
• Do not use after expiration date.
• The test should remain in the sealed pouch until use.
• The used test should be discarded according to local regulations.
【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.
【SAMPLE COLLECTION AND STORAGE】
• The Malaria P.f/ Pan Rapid Test Device (Whole Blood) is intended for use with human whole blood specimens only.
• Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. For long term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 3 days of collection.
• Containers containing anticoagulants such as EDTA, citrate, or heparin should be used for whole blood storage.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
• If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
【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.
【PERFORMANCE CHARACTERISTICS】
Sensitivity For Pan: Relative Sensitivity: 99.37% (157/158)
For P.f: Relative Sensitivity: 98.15% (53/54)
Specificity The Malaria P.f/ Pan Rapid Test uses highly specific antibodies for MalariaP.f/ Panantigens in whole blood. The results show that the specificity of the MalariaP.f/Pan. Rapid Test is relative to microscopy.
Relative Specificity: 99.08% (324/327)
Accuracy: 99.07%
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