Intended Use
This product is suitable for the qualitative clinical screening of serum/plasma/whole blood samples for the detection of antibodies against Lyme disease. It is a simple, rapid and non-instrumental test.
Test Principle
This is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant antigen conjugated with colloid gold and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test bands (M and G bands) and a control band (C band).
Materials / provided; | Quantity (1 Test/Kit) | Quantity(5Tests/Kit) | Quantity(25Tests/Kit) |
Test Kit | 1 test | 5 tests | 25 tests |
Buffer | 1 bottle | 5 bottles | 25/2 bottles |
Dropper | 1 piece | 5 pcs | 25 pcs |
Specimen Transport Bag | 1 piece | 5 pcs | 25 pcs |
Disposable Lancet | 1 piece | 5 pcs | 25 pcs |
Instructions For Use | 1 piece | 1 piece | 1 piece |
Certificate of Conformity | 1 piece | 1 piece | 1 piece |
Collect human Serum/Plasma/Whole blood properly.
(1) Remove an extraction tube from the kit and a test box from the film bag by tearing the notch. Put them on the horizontal plane. Open the inspection card aluminum foil bag. Remove the test card and place it horizontally on a table.
(2) Use a disposable pipette, transfer 4μL serum (or plasma), or 4μL whole blood into the sample well on the test cassette.
(3) Open the buffer tube by twisting off the top. Put 3 drops (about 80 μL) of assay diluent into the assay diluent well round shaped. Srart counting.
Read the result at 10-15 mins. Results after 20 minutes are invalid.
Negative result
Only the quality control line C appears and the detection lines G and M do not show, it means that no antibody is detected and the result is negative.
Positive Result
If both the quality control line C and the detection line M appear =the Lyme disease IgM antibody is detected, and the result is positive for the IgM antibody.
If both the quality control line C and the detection line G appear=the Lyme disease antibody is detected and the result is positive for the IgG antibody.
If both the quality control line C and the detection lines G and M appear=the Lyme disease IgG and IgM antibodies are detected, and the result is positive for both IgG and IgM antibodies.
Invalid Result
If the quality control line C cannot be observed, results will be invalid regardless of whether a test line shows, and the test should be repeated.
Product Name | Cat. No | Size | Specimen | Shelf Life | Trans. & Sto. Temp. |
Lyme disease IgG/IgM Rapid Test Kit(Immunochromatographic Assay) | B026CH-01 | 1test/kit | S/P/WB | 18 Months | 2-30℃ / 36-86℉ |
B026CH-05 | 5 tests/kit | ||||
B026CH-25 | 25 tests/kit |