High Accuracy One Step Gonorrhea Rapid Diagnostic test cassette , gold colloidal method, easily and quick

Product Name: One Step Gonorrhea Rapid Diagnostic test cassette

Accessories:

Intended Use:

The Gonorrhea Rapid Test Cassette (Swab) is a rapid chromatographic immunoassay for the qualitative detection of Neisseria gonorrhoeae in female cervical swab and male urethral swab specimens to aid in the diagnosis of Gonorrhea infection.

Summary:

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 lowerabdominal 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 examination1 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.2A smear or swab of urethral or cervical discharge may be taken and tested using a Gonorrhea Rapid Test Cassette (Swab)

TEST PRINCIPLE

The Gonorrhea Rapid Test Cassette (Swab) is a qualitative, lateral flow immunoassay for the detection of Gonorrhea antigen from female cervical and male urethral. In the test, antibody specific to the Gonorrhea antigen is coated on the test line region of the test. During testing, the extracted antigen solution reacts with an antibody to Gonorrhea that is coated onto particles. The mixture migrates up to react with the antibody to Gonorrhea on the membrane and generates a color line in the test region. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

Collecting the specimen:

1. Start up by adding 300ul (about 8-9 drops) of buffer A to the attached mixing tube. Then use a swab to collect specimen in the following suggested method:

a) For male patient: Insert the swab into the urethra of the penis. Gently rotate with sufficient pressure to dislodge the epithelial cells. Allow the swab to remain inserted for a few seconds after rotation. Carefully remove the swab avoiding contact with any external surfaces.

b) For female patient: Use swab number 1 to remove discharges from the vaginal track opening. Then insert swab number 2 into vaginal track for half a minute and retrieve swab. Carefully remove the swab avoiding contact with any external surfaces.

1. Place swab into the tube and mix well with buffer A so that discharges are well suspended in the buffer A. Discard swab into disinfectant container.
2. Add 300 ul (about 8-9 drops) of buffer B to the tube, cap the tube and mix well.

TEST PROCEDURE

1. Use the dropper, draw 0.1ml (about 4 drops) sample into the pipette, and dispense it into the sample well on the cassette.
2. Wait 10 –15 minutes and read results. Do not read results after 30 minutes.

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS

Positive:

Two red lines are visible in the result window. The intensity of the test line may be

weaker or darker than that of the control line. This still means a positive result.

Negative:

The control line appears in the result window, but the test line is not visible.

Invalid:

If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical  Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

Company's core technical team with more than 35 employees，3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.