Tri-line Malaria pf/pan antibody Home Testing kits, personal
use,individual package, blood test
Product Name:
Tri-line Malaria pf/pan antibody Home Testing kits
INTENDED USE: Malaria P.f & Pan Ab test is an immunochromatographic (rapid) test
for the qualitative detection of antibodies of all isotypes (IgG,
IgM, IgA) specific to Plasmodium falciparum, Plasmodium vivax,
Plasmodium ovale, Plasmodium malariae simultaneously in human serum
or plasma or whole blood.
SUMMARY:
Malaria is a serious paraitc disease characterized by
fever,chills,and anemia and is caused by a parasite that is
transmitted from one human to another by the bite of infected
Anopheles mosquitoes.There are four kinds of malaria that can
infect humans.There four kinds of malaria that can infect
humans:Plasmodium falciparum,P.vivax,P.ovale,and P.malariae.In
humans,the parasites migrate to the liver where they mature and
release another form,the merozoites.
The One-Step Malaria pf/pan Detection Test Device(Whole Blood)
contains a membrane strip,which is pre-coated with two monoclonal
antibodies as two separate lines across a test strip.One monoclonal
antibody(test line 1)is specific to the p.falciparum histidine rich
protein-2(Pf HRP-2) and another monoclonal antibody(test line 2) is
pan specific to the lactate dehydrogenase of Plasmodium
species(P.falciparum,vivax,malariae,ovale).Conjugate pad is
dispensed with monoclonal antibodies conjugated to colloidal
gold,which are specific to P.falcparum histidine rich protein-2(Pf
HRP-2)and pan specific to the lactate dehydrogenase of Plasmodium
species.
SPECIMEN COLLECTION
Collect whole blood into a collection tube (containing EDTA,citrate
or heparin) by venipuncture.
If specimens are not immediately tested,they should be refrigerated
at 2~8.For storage periods greater than three days,freezing is
recommended.They should be brought to room temperature prior to
use. Using the specimen after long-term storage of more than three
days can cause non-specific reaction.
When stored at 2~8℃,the whole blood sample should be used within
three days.
INTERPRETATION OF RESULTS
1. NEGATIVE RESULT: If only the C band is present, the absence of any burgundy color
in the both T bands (T1 and T2) indicates that no anti-plasmodium
antibodies are detected. The result is negative.
2. POSITIVE RESULT:
2.1 In addition to the presence of C band, if only T1 band or both
T1 and T2 band are developed, the test indicates for the presence
of antibodies to Pf in the specimen. The result is Pf positive.
2.2 In addition to the presence of C band, if only T2 band is
developed, the test indicates for the presence of antibodies to Pf,
P. vivax, oval, and or malariae in the specimen. The result is
positive.
3. INVALID: If no C band is developed, the assay is invalid regardless of any
burgundy color in the T bands as indicated below. Repeat the assay
with a new device.In addition to the presence of C band, if only T2
band is developed, the test indicates for the presence of
antibodies to Pf, P. vivax, oval, and or malariae in the specimen.
The result is positive.
Performance Study
| Method | Microscopy | Total Results |
Malaria P.f/ Pan. Rapid Test Device | Results | Positive | Negative |
| P. v | P. f |
| Positive | Pan | 103 | 0 | 0 | 103 |
| P.f | 0 | 43 | 2 | 45 |
| Negative | 0 | 0 | 213 | 213 |
| Total Results | 146 | 215 | 361 |
| ORIENT NEW LIFE MEDICAL CO., LTD. |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
