Tri-line Malaria pf/pv antibody Home Testing kits, individual
package, whole blood test 4mm cassette full kit
Product Name: Malaria P.f & P.v antibody Home Testing kits
INTENDED USE: Malaria P.f & P.v Ab test is an immunochromatographic (rapid) test
for the qualitative detection of antibodies of all isotypes (IgG,
IgM, IgA) specific to Plasmodium falciparum and Plasmodium vivax
simultaneously in human serum or plasma or whole blood.
SUMMARY:
Malaria is a serious, sometimes fatal, parasitica disease
characteristic 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. Malaria pf/pv Ab test is an
immunochromatographic test for the qualitative detection of
antibodies of all isotypes specific to pf and pv simultaneously in
human serum or plasma or whole blood.
TEST PRINCIPLE
A capture monoclonal antibody is immobilized on the membrane within
the cassette. The red blood cells are lysed releasing Pf. HRP11 and
P. vivax specific pLDH which binds selectively to this antibody as
the blood flows along the strip inside the cassette. The signal
reagent is coated with specific antibodies, which bind with the
antibody-antigen complex, producing a black line. The presence of
an upper black line (the control line) demonstrates the test has
been performed correctly.
INTERPRETATION OF RESULTS
Malaria P.f Positive
The control line and Malaria P.f line (T1) are visible in the
result window. The test is positive for Malaria P.f.
Malaria P.v Positive
The control line and Malaria P.v line (T2) are visible in the
result window. The test is positive for Malaria P.v.
Malaria P.f and Malaria P.v Positive
The control line, Malaria P.f (T1) and Malaria P.v (T2) lines are
visible in the result window. The test is positive for Malaria P.f
and Malaria P.v.
Negative
The control line is the only line visible in the result window. No
Malaria P.f or Malaria P.v has been detected.
Invalid
If the control line does not appear in the result window, the test
results are INVALID regardless of the presence or absence of the
line in the test region.
Performance Study
The following data was generated from previously frozen whole blood
samples and was determined by correlation to standard thick and
thin smear microscopic examination with discrepancies evaluated via
PCR. Retrospective study results are summarized below:
| Site | Pos | Neg | Test Pos | Test Neg |
| India | 66 | 86 | 64 (97%) | 86 (100%) |
| Senegal | 8 | 10 | 8 (100%) | 10 (100%) |
| Varied Origin | 48 | 53 | 46 (95.8%) | 53 (100%) |
| South Africa | 102 | 150 | 99 (97%) | 149 (99.3%) |
| TOTAL | 224 | 299 | 217 (96.9%) | 298 (99.7%) |
| ORIENT NEW LIFE MEDICAL CO., LTD. |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
