Unit: 1 Box (25 Tests)
Regulatory Status: CLIA Moderately Complex / Professional Use Only
Contents: (25) Test Cassettes, (1) Reagent A, (1) Reagent B, (25) Tubes – Tips & Disposable Droppers, (25) Tranport Tubes 2 sterile swabs, (1) Positive Control, (1) Negative Control, (1) Package Insert, (1) Procedure Card
Determinations: Qualitative Chlmydia
Storage Requirements: 59° – 86° F
Processing Time: 12 minutes
The QuickVue Chlamydia Test is an inexpensive, on-site assessment that offers a qualitative result to determine the presence or absence of Chlamydia trachomatis in 12 minutes or less. Chlamydia trachomatis, an obligate intracellular human pathogen, is the bacteria responsible for the sexually transmitted disease simply known as Chlamydia. An estimated 2.8 million infections occur annually in the U.S., many due to the asymptomatic nature of the infection.
QuickVue Chlamydia Test Includes:
25 Test Cassettes
1 set Positive & Negative Controls
1 Package Insert
25 Tubes with tips
25 Disposable Droppers
25 Transport Tubes (each containing 2 swabs)
1 Procedure Card
- Inexpensive – No costly equipment needed
- Accurate – 92% Sensitivity; 99% Specificity (in overall population)
- Excellent Performance – Includes both Internal & External Controls to insure compliance and confidence in results
- Easy to Read Results – Two-color endpoint
- Convenience – Patients can be tested and treated in the same office visit
- Long Shelf Life – 9 months from date of manufacture
- No special storage or shipping required – Stable at Room Temperature (59-86 degrees F)
Chlamydia trachomatis, a Gram-negative bacterium, is one of three human biovars in the genus Chlamydia. Serovars (subdivisions grouped based antigenicity) D through K are chiefly responsible for urogenital infections. This sexually transmitted pathogen is the most common, curable sexually transmitted infection. An estimated 2.8 million cases are reported in the U.S. each year. The bacteria is most often transmitted through sexual contact which includes not only vaginal and anal intercourse but also with the use of sexual toys, oral-genital contact and even kissing. Chlamydia infections can occur in the mouth and throat as well as the male and female genitalia and anal regions.
Chlamydia is often asymptomatic for both males and females. Only about 30% of infected women display symptoms. If symptoms do occur, they usually appear within 1 to 3 weeks after initial exposure. The symptoms range from minor discomforts such as a low back or abdominal pain, burning sensation during urination, painful sexual intercourse, and vaginal or rectal discharge to more serious symptoms such as pelvic inflammatory disease, salpingitis, and liver inflammation similar to hepatitis. An untreated infection can lead to long-term damage to a woman’s reproductive organs and result in increased risk of ectopic pregnancies and infertility. If a woman is infected with chlamydia while pregnant, the infection can pass to her baby during vaginal childbirth, leading to serious eye damage (conjunctivitis) or pneumonia. For this reason, newborns are routinely treated with antibiotic eye drops at birth as a preventative to an often asymptomatic maternal infection.
Testing for Chlamydia is strongly recommended for all sexually active women, especially for those under the age of 25, for women who engage in unprotected sex and are not in a monogamous relationship, and for women who are pregnant. Simple, accurate tests for the detection Chlamydia, such as the QuickVue Chlamydia Test, are now readily available and offer a quick, definitive answer so that a treatment plan can be arranged during the same office visit. The proper use of condoms during intercourse reduce the risk of infection; however, an annual screening is recommended by the CDC for those with the previously mentioned risk factors for chlamydial infections. Diagnosis and antibiotic therapy are the only courses of eradication to prevent more serious conditions that Chlamydia can cause.
CLIA Moderately Complex – 87810