ACCU-TELL GONORRHEA TEST
Declaration: As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
Catalog No. Product Name
ABT-STD-A16 Gonorrhea Strip
ABT-STD-B16 Gonorrhea Cassette
Accu-Tell ® Rapid Gonorrhea Test is intended for the immunochromatographic, qualitative determination of gonorrhea directly from swab samples.
Accu-Tell ® Rapid Gonorrhea Test is based on the principle of sandwich immunoassay for the determination of gonorrhea antigen in the secrectory products and urine from urinary system as an aid in the diagnosis of gonococcus infection. Monoclonal and polyclonal antibodies were employed to specifically identify gonorrhea with high sensitivity.
1. For in vitro diagnostic use only.
2. Do not use kit beyond the expiration date.
3. Samples may be infectious; properly handle and dispose of all used reaction devices in the biohazard co ntainer.
4. Wear disposable gloves throughout the specimen collection and assay procedure.
5. The test device should not be reused.
1. Add 300ul (about 6 drops) of Reagent A to a clean tube. Then use a swab to collect specimen in the following suggested method:
a) For male patient: Swab discharges from the opening of the urinary track. If not discharges are present, insert swab 2-3 cm into urinary track, gently move a few turns and retrieve swab.
b) For female patient: Swab discharges from the vaginal track opening, then insert swab into vaginal track for half a minute and retrieve swab.
2. Place swab into the tube and mix well with Reagent A so that discharges are well suspended in the Reagent A. Discard swab into disinfectant container.
3. Add 100 ul (about 2 drops) of Reagent B to the tube and mix well.
Bring all samples to room temperature prior to testing. Remove the test strip from the foil pouch when ready to perform the test.
For Test Cassette:
1. Draw 0.2ml (about 6 drops) sample into the pipette, and dispense it into the sample well on the cassette.
2. Wait 10 –20 minutes and read results. Do not read results after 30 minutes.
For Test Strip:
1. Dip the test strip with arrow downwards into the specimen for about 5 seconds. Do not exceed the marker line.
2. Wait 10 –20 minutes and read results. Do not read results after 30 minutes.
POSITIVE Two distinct red lines will appear, one in the test region ( T ) and another in the control region ( C ).
Note: Very high-positive patient samples may result in a very weak control band. However, the test is still valid, no matter how strong or weak a control band appears.
NEGATIVE Only a single red line appears in the control region ( C ). No apparent red of pink line appears in the test region ( T ).
INVALID The lines in both regions fall to appear, as means improper testing procedures or deterioration of reagents probably have occurred. It is recommended that the sample be retested.
The test contains built-in quality control features. The development of a colored line in the control zone indicates that the patient sample has been absorbed into the membrane, that capillary flow has occurred, and that antibody reactivity is at the required level.
As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
The test kit can be stored at room temperature (2 to 30℃) in the sealed pouch for duration of shelf life. The test kit should be kept away from direct sunlight, moisture and heat.
The above information is just for reference. The actual technical specifications are subject to the insert provided with the product.
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