INTENDED USE

Rapid Lyme Ab Test Kit is a sandwich lateral flow immunochromatographic assay for the qualitative detection of Lyme antibody in dog’s blood specimen.

PRINCIPLE

Lyme Disease Antibody Rapid Test Kit is based on sandwich lateral flow immunochromatographic assay. The test device has a testing window. The testing window has an invisible T (test) zone and C (control) zone. When sample is applied into the sample hole on the device, the liquid will laterally flow on the surface of the test strip. If there is enough Lyme Disease Antibody Rapid Test in the sample, a visible T band will appear. The C band should always appear after a sample is applied, indicating a valid result. By this means, the device can accurately indicate the presence of Lyme Disease Antibody Rapid Test in the sample.

KIT COMPONENT

-Test device, with disposable dropper

– Assay buffer

– Product Manual

STORAGE & SHELF LIFE

Store at 2-30°C, out of sun light and moisture.

Shelf Life: 24 months

TEST PROCEDURE

1. Collect dog’s whole blood and centrifuge it to get serum or plasma. Or use whole blood with anticoagulants as specimen.  For whole blood sample without anticoagulant must be tested immediately.

2. Specimens and test kit stored at 2-8℃ should be  recovered to room temperature before use.

3. Take out the test device from the foil pouch and place it horizontally.

4. Use the dropper to dispense 10ul (black line) of specimen into the sample hole “S”. Then drip 3 drops of assay buffer into the sample hold.

5. Interpret the result in 5-10 minutes. Result after 10 minutes is considered as invalid.

INTERPRETATION OF RESULTS

Positive: Two lines appear, no matter T line is clear or vague.

Negative: Only C line appears.

Invalid: No line appears or only T line appears.

PRECAUTIONS

1. Expired test or the test with damaged foil pouch should not be used.

2. The test must be used within 10 minutes after opening the foil pouch.

3. Do not use specimen with hemolysis or be contaminated with microbes, which will cause false positive or false negative result.

4. Do not reuse the test kit and do not mix components from different lot numbers.

5. All specimens have potential infection. It must be strictly treated according to the rules by local states.

LIMITATION

SHENUNGTEX Rapid Lyme Ab Test Kit is for in vitro veterinary diagnosis use only. All results should be considered with other clinical information available from veterinarian. For an accurate result, It is suggested to apply other method such as PCR for final determination in practice.