Introduction
Product | Leptospira Rapid Test Kit |
Specimen | Whole blood,plasma,serum |
Components | Individually packed test devices,Disposable pipettes, Buffer, Package insert |
Sensitivity | 90% |
Specificity | 99% |
Accuracy | 98.6% |
Storage | 2-30℃ |
Validity | 24 Months |
INTENDED USE
The Leptospira IgG/IgM Rapid Test-sheet is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM antibody to Leptospira interrogans (L. interrogans) in human serum, plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with L. interrogans. Any reactive specimen with the Leptospira IgG/IgM Rapid Test-sheet must be confirmed with alternative testing method(s).
INTRODUCTION
The Leptospira IgG/IgM is a simple serological test that utilizes antigens from L. interrogans and detects IgG and IgM antibodies to these microorganisms simultaneously. The test can be performed by untrained or minimally skilled personnel, without cumbersome laboratory equipment and the result is available within 15 minutes.
For Cassette
1.Review “Specimen collection” instructions. Test device, patient’s samples, and controls should be brought to room temperature (20-30℃) prior to testing. Do not open pouches until ready to perform the assay.
2.Remove the test device from its protective pouch (bring the device to room temperature before opening the pouch to avoid condensation of moisture on the membrane). Label the device with patient or control number.
3.Hold the dropper vertically and transfer 3 full drops of urine (approx. 0.15ml) to the specimen well (S) of the test device, and then start the timer. Use a separate pipette and device for each sample or control.
4.Read result between 3 to 8 minutes after the addition of samples. Do not read result after 8 minutes.
How To Read ?
Positive: Only one pink band appears on test region of the Cassette.
Negative: Two pink bands appear on test region of the Cassette.
Invalid: If without colored band appears on test region, this is an indication of a possible error in performing the test. The test should be repeated using a new device.
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