Testsealabs Malaria AG P. F/Pan Tri-Line Test Infectious Disease Rapid Test Kit

• Type: IVD Reagent
• Certificate: ISO 13485
• Storage Temperature: 4-30°c
• Shelf Life: 2 Years
• OEM: Available
• Transport Package: Cartons
• Model NO.: 101030
• Trademark: Testsealabs
• Origin: Hangzhou, China
• Production Capacity: 100000pieces/Day

Product Description

Format	Cassette	Package	Cartons
Specimen	WB	Certificate	ISO 13485
Storage Temperature	4-30°C	Pack	40T
Test Time	15 min	Shelf life	2 years
Sensitivity	>99%	OEM	Available

Summary
Malaria is caused by a parasite called Plasmodium, which is transmitted via the bites of infected mosquitoes. In the human body, the parasites multiply in the liver, and then in blood cells. Symptoms of malaria include fever, headache, and vomiting, and usually appear between 10 and 15 days after the mosquito bite. If not treated, malaria can quickly become life-threatening by disrupting the blood supply to vital organs. In many parts of the world, the parasites have developed resistance to a number of malaria medicines.


For Whole Blood specimen:
Use a pipette: To transfer 5μL of whole blood to the specimen well, then add 3 drops of buffer (approximately 180μL)
Use a disposal specimen dropper: Hold the dropper vertically, draw the specimen up to the Fill Line as shown in illustration below (approximatel5μL).Transfer the specimen to the specimen well, then add 3 drops of buffer (approximately 180μL). and start the timer
3.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes

Specificity
Malaria P.f./Pan Rapid Test Cassette (Whole Blood) uses antibodies that are highly specific to Malaria P.f.-specific and Pan-malariai antigens in whole blood. The results show that the specificity of Malaria P.f./Pan Rapid Test Cassette (Whole Blood) is >99.9%,when compared to results obtained with microscopy

LIMITATIONS
1.Malaria P.f/Pan Rapid Test Cassette (Whole Blood) is for in vitro diagnostic use only. This test should be used for the detection of P.f., P.v.,Po.,Pm. antigens in whole blood specimens only. Neither the quantitative value nor the rate of increase in P.f., P.v., P.o., and P.m. concentration can be determined by this qualitative test.
2. Malaria P.f./Pan Rapid Test Cassette (Whole Blood) will only indicate the presence of antigens of Plasmodium sp. (P.f., P.v., P.o.,P.m.) in the specimen and should not be used as the sole criterion for the diagnosis of malaria infection
3.As with all diagnostic tests. all results must be interpreted together with other clinical information available to the physician
4.lf the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of malaria infection