CE-marked
Sensitivity: 99.6%
Specificity: 99.7%
INTENDED USE
The Advanced Quality Rapid Malaria Test (Pf/Pan) is a rapid, qualitative and differential test for the detection of HRP-Ⅱ (Histidine rich protein Ⅱ) specific to Plasmodium falcifarum and pLDH (Plasmodium lactate dehydrogenase) pan (P. vivax, P.malariae, P.ovale) specific to Plasmodium species in human blood sample. This test is a rapid test as an aid in the diagnosis of relative infection and relative symptom; it only provides preliminary analysis results but not critical diagnosis criteria, the obtained results should be analyzed in connection with other clinical information, e.g. clinical symptoms, and alternate test to make final decision. The test is intended for healthcare professional use.
PRODUCT PARAMETERS
﹒CE-marked
﹒Sensitivity: 99.6%
﹒Specificity: 99.7%
﹒Specimen: whole blood, serum or plasma
﹒Test time: 15-20 minutes
﹒Storage temperature: 2-30℃
﹒Shelf life: 24 months
|
Retrospective study results |
||||
|
Site |
Positive |
Negative |
Sensitivity |
Specificity |
|
India |
66 |
86 |
66（100%） |
86(100%） |
|
Senegal |
8 |
10 |
8 (100%) |
10(100%) |
|
South Africa |
102 |
150 |
101(99%) |
149(99.3%) |
|
Varied Origin |
28 |
53 |
48(100%) |
53(100%) |
|
Total |
224 |
299 |
223(99.6%) |
298(99.7%) |
ORDERING INFORMATION
|
Product |
Cat. No. |
Type |
Pack Size |
Specimen* |
Cert. |
|
Malaria Pf/ Pan |
ITP11005-TC40 |
Cassette |
40T |
WB |
CE |
|
ITP11005-TC25 |
Cassette |
25T |
WB |
CE |
|
|
*Specimen: WB=Whole Blood |
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