| Customization: | Available |
|---|---|
| Cold Hot Dressing Application: | Malaria P.F &Pan Rapid Test Kits |
| Usage Mode: | For External Use |
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The Malaria Pf &Pan Rapid Test Device (Whole Blood)is a qualitative,membrane based immunoassay for the detection of P.f,P.v,Po and P.m antigens in whole blood.The membrane is pre-coated with anti-HRP-ll antibodies and anti-Lactate Dehydrogenase antibodies.During testing,the whole blood specimen reacts with the dye conjugate, which has been precoated on the test strip.The mixture then migrates upward on the membrane by capllary action, reacts with anti-Histidine-Rich Proteinl(HRP-II)antibodies on the membrane on P.f Test Line region and with anti-Lactate Dehydrogenase antibodies on the membrane on Pan Line region If the specimen contains HRP-l or Plasmodium-specific Lactate Dehydrogenase or both,a colored line will appear in P.f line region or Pan line region or two colored lines will appear in Pf line region and Pan line region.The absence of the colored lines in P.f line region or Pan line region indicates that the specimen does not contain HRP-ll and/or Plasmodium-specific Lactate Dehydrogenase.To serve as a procedure control,a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
Principle:Chromatographic Immunoassay
Format:Cassette
Package:1 test/pack,25 tests/pack,50 tests/pack
Sample Size:5μL
Sample:Whole Blood
Operation Temperature:15-30ºC
Storage Temperature:2-30ºC
Test Time:15-20 mins
Shelf Life:24 months
RAPID
Results seen in 10 minutes. Enables immediatetreatment.
EASY TO USE
Simple test using only 1 reagent. Requires a smallblood sample easily collected by fingerstick. Noneed for skilled microscopist.
EASY TO INTERPRET
Differentiated results allow diagnosis of potentiallylethal P. falciparum infection.Objective, qualitativeresults. Easy to read, qualitative results.
Atotal of305 patient samples from susceptible subjects were tested with our Malaria P.f &Pan rapid test and traditional thick orthin bloodsmears microscopic analysis.Comparison for all subjects is showed in the following table:
| Product | Traditional thick or thin blood smears microscopic analysis | ||||
| Malaria P.f & Pan Test | Double negative | P.f+,Pan- | P.f-,Pan+ | Double Positive | Total |
| Double negative | 158 | 0 | 1 | 0 | 159 |
| P.f+.Pan- | 0 | 30 | 0 | 0 | 30 |
| P.f-,Pan+ | 0 | 0 | 51 | 1 | 52 |
| Double Positive | 0 | 1 | 0 | 63 | 64 |
| Total | 158 | 31 | 52 | 64 | 305 |
| The Malaria P.f & Pan Rapid Test(Whole Blood) has been compared width traditional thick or thin blood smears microscopic analysis | |||||
| Clinical Performance for P.f Ag Test: | Clinical Performance for Pan Ag Test: | ||||
| Relative Sensitivity:98.95% | Relative Sensitivity:99.14% | ||||
| Relative Specificity:100% | Relative Specificity:99.47% | ||||
| Overall Agreement:99.67% | Overall Agreement:99.34% | ||||
| Principle | Chromatographic Immunoassty | Operation Temperature | 15-30ºC |
| Format | Cassette | Storage Temerature | 2-30ºC |
| Certificate | CE | Test Time | 10 min |
| Package specifications | 1 test/pack, 5 tests/pack, 25 tests/pack | Shelf Life | 24 months |
| Sample Type | Whole Blood |
1.To use a Pipette: Transfer 5uL of whole blood to the specimen well(S).
2.To use a Disposable Specimen Dropper:Hold the dropper vertically, draw the specimen up to the Fil Line as shown i illustrationbelow (approximately 5uL).
3.Add 3 drops of buffer (approximately 120uL), and start the timer.
4.Wait for the colored line(s) to appear. The result should be read at 10 minutes.Do not interpret the result afiter 20 minutes.
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