The Gonorrhea Rapid Test Device (Swab) is a rapid visual immunoassay for the qualitative presumptive detection of Neisseria gonorrhoeae in female cervical swab and male urethral swab specimens. This kit is intended for use as an aid in the diagnosis of Gonorrhea.
Gonorrhea is a sexually transmitted disease caused by the bacterium Neisseria gonorrhoeae. Gonorrhea is one of the most common infectious bacterial diseases and is most frequently transmitted during sexual intercourse, including vaginal, oral and anal sex. The causative organism can infect the throat, producing a severe sore throat. It can infect the anus and rectum, producing a condition called proctitis. With females, it can infect the vagina, causing irritation with drainage (vaginitis). Infection of the urethra may cause urethritis with burning, painful urination, and a discharge.
When women have symptoms, they often note vaginal discharge, increased urinary frequency, and urinary discomfort. Spread of the organism to the fallopian tubes and abdomen may cause severe lower-abdominal pain and fever. The average incubation for Gonorrhea is approximately 2 to 5 days following sexual contact with an infected partner. However, symptoms may appear as late as 2 weeks. A preliminary diagnosis of Gonorrhea can be made at the time of examination. 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 Device (Swab).
- Reactive: Positive —- If two colored bands are visible within 20 minutes, the test result is reactive or positive and valid. The test result can be read as soon as a distinct colored band appears in the test area.
- Non-reactive: Negative —- If test area has no color band and the control area displays a colored band, the result is non-reactive or negative and valid.
- Invalid result —- The test result is invalid if a colored band does not form in the control region. The sample must be re-tested, using a new test device.
- Qualitative results in 15 minutes
- 99.28% sensitivity
- 99% accuracy
- Take sample at any time of the day
For female endocervical specimens:
- Use only Dacron tipped sterile swabs. It is recommended to use the swab supplied by the kits manufacturer. Swabs with cotton tips are not recommended
- Before specimen collection, remove excess mucus from the endocervical area with a separate swab or cotton ball and discard . With the swab , insert into the endocervix and pass the squamocolumnar junction until most of the tip is no longer visible. This will permit acquisition of columnar or cubical epithelial cells which are the main reservoir of Chlamydia organism. Firmly rotate (clockwise or anticlockwise) the swab in a circle and stay for 5-10 seconds without contamination with exocervical or vaginal cells
- Put the swab into the extraction tube, if the test may be run immediately
For male urethral specimens:
- Standard Dacron tipped sterile swabs should be used for urethral specimen collection. Instruct the patients not to urinate at least one hour prior to specimen collection
- Insert the swab into the urethra about 2-4cm; firmly rotate (clockwise or anticlockwise) a circle and stay for 5-10 seconds , withdraw it, and place it into the extraction tube, if the swab may be tested immediately. If not, place the specimen into a dry transport tube for transport and storage. The swabs maybe stored for 4-6 hours at room temperature (15-30°C) or 24-48 hours at 2-8°C, freeze is forbidden.
- All specimens should be brought back into room temperature of 15-30°C before testing.
For male urine specimens:
- Collect the first urine (approximately 15-30ml) in the morning. The maximum of C.trachomatics antigens can be detected from the first urine in the morning.
- Specimen should be stored 24 hours at 2-8°C, if immediate testing is not allowed
- Shake and mix the specimen, 10ml specimen is drawn into centrifugal tube with 10ml distilled water, centrifugate the mixture at 3000rpm/s for 15-20 mins.
- Discard the supernatant carefully. Turn over the centrifugal tube, absorb the residual urine with absorbent paper.
Storage & Stability:
The test kits can be stored at room temperature (4 to 30°c) in the sealed pouch to the date of expiration. The test kits should be kept away from direct sunlight, koisture and heat.