CE ISO Gonorrhea Rapid Test Kit Cassette Swab Cervical Type
In women, Gonorrhea is a common cause of pelvic inflammatory disease (PID). PID can lead to internal abscesses and long-lasting, chronic pelvic pain. PID can damage the fallopian tubes enough to cause infertility or increase the risk of ectopic pregnancy. A smear or swab of urethral or cervical discharge may be taken and tested using a Gonorrhea Rapid Test.
[CONTENTS]
• Rapid test cassette with desiccant
• Buffer
• Disposable pipettes
• Disposable swab
• Package insert
[SAMPLE COLLECTION]
• The quality of specimen obtained is of extreme importance. Detection of gonorrhea/chlamydia requires a vigorous and thorough collection technique which provides cellular material rather than just body fluids. Do not use 0.9% sodium chloride to treat swabs before collecting specimens.
For female cervical specimens:
• Use the swab provided with the kit.
• Before specimen collection, remove excess mucus from the endocervical area with a separate swab or cotton ball and discard. The swab should be inserted into the endocervical canal, past the squamocolumnar junction, until most of the tip is no longer visible. This will permit acquisition of columnar or cuboidal epithelial cells which are the main reservoir of gonorrhea/chlamydia organisms. Firmly rotate the swab for 15 - 20 seconds without contamination with exocervical or vaginal cells.
• If the swab may be tested immediately, replace the swab into the extraction tube.
For male urethral specimens:
• Standard wire-shafted fiber-tipped swabs or cytology brushes (not provided) should be used for urethral specimen collection. Instruct the patients not to urinate at least one hour prior to specimen collection.
• Insert the swab 2-4 cm into the urea, rotate for 3-5 seconds and withdraw it. If the swab may be tested immediately, replace the swab into the extraction tube.
For male urine specimens:
• Collect 15-30 mL of clean first morning urine in a sterile urine cup. First morning urine specimens are preferred to achieve the highest concentrations of Gonorrhea/Chlamydia antigen.
• Mix the urine specimen by inverting the container. Transfer 10 mL of the urine specimen into a centrifuge tube, add 10 mL distilled water and centrifuge at 3,000 rpm for 15 minutes.
• Carefully discard the supernatant, keep the tube inverted and remove any supernatant from the rim of tube by blotting onto absorbent paper.
• If the test is to be conducted immediately, treat the urine pellet according to the Directions for Use.
• Do not place the swab in any transport device containing medium. Transport medium interferes with the assay, and viability of organisms is not required for the assay. If immediate testing is not possible, patient samples should be placed in a dry transport tube for storage or transport. The swabs may be stored for 4 hours at room temperature (15-30°C) or 24 hours refrigerated (2- 8°C). The urine specimens can be stored refrigerated (2-8°C) for 24 hours.
Do not freeze. All specimens should be allowed to reach a room temperature of 15- 30°C before testing.
Specimen Storage:
It is recommended that specimens be processed as soon as possible after collection. If test is not performed immediately, the swab specimens should be placed in a dry transport tube for storage or transport. The swab may be stored for 4-6 hours at room temperature (15-30℃) or refrigerated (2-8℃ ) for 24 hours. Do not freeze. All specimens should be equilibrated to room temperature (15-30℃ ) before testing.
【DIRECTION OF TESTING】
Allow the test, specimen, reagents, and/or controls to reach room temperature (15- 30℃) prior to testing.
1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Extract the Gonorrhea/Chlamydia antigen according to the specimen type.
For Female endocervical or Male urethral swab specimens:
• Place a clean extraction tube in the workstation. Add 5 drops of Ragent 1 to the extraction tube.
• Immerse the patient swab into the extraction tube and wait 2 minutes. While waiting, use a circular motion to roll the swab against the side of the extraction tube so that the liquid is expressed from the swab and can reabsorb.
• Add 6 drops of Reagent 2. Squeeze the swab firmly against the tube to expel as much liquid as possible from the swab for 1 minute. Discard the swab following guidelines for handling infectious agents. Fit the dropper tip on top of the extraction tube.
• The extracted specimen can remain at room temperature for 60 minutes without affecting the test result.
For Male urine specimens:
• Add 6 drops of Reagent 2 to the urine pellet in the centrifuge tube, then draw the liquid up and down with a pipette to vigorously mix until the
suspension is homogeneous.
• Transfer all the solution in the centrifuge tube to an extraction tube. Let stand for 2 minute. Hold the Reagent 2 bottle upright and add 5 drops of Reagent 1 to the extraction tube. Vortex or tap the bottom of the tube to mix the solution. Let stand for 1 minutes.
• Fit the dropper tip on top of the extraction tube.
3. Add 2 drops (approximately 50 µL) of extracted specimen from the extraction tube to the specimen well (S) of the test cassette.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result window.
As the test begins to work, color will migrate across the membrane.
4. Wait for the colored band(s) to appear. The result should be read at 10
minutes. Do not interpret the result after 20 minutes.
[INTERPRETATION OF RESULTS]
POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.The result window indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.
INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.
[ABOUT US]
DEWEI Medical Equipment Co., Ltd is a leading and professional manufacturer of IVD products,it is a high-tech enterprise specialized in developing, manufacturing and marketing of Clinical Laboratory analyzer & reagents, such as Hematology Analyzer & Reagents, Virus RNA Preservation & Extraction Kits, Urine Sediment Reagents and Washing Solutions.
DEWEI products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research center and college laboratories.
Qulity is primary concern, DEWEI team is strict on quality control systems thus our products have CE, ISO, CFDA and other international standards certificates.
The view of DEWEI is to be the most professional and respected enterprise in IVD field, DEWEI will go on providing best service to you by the outstanding R&D and cost-effective products.
Your message must be between 20-3,000 characters!