Hangzhou Aichek Medical Technology Co.,Ltd
Hangzhou Aichek Medical Technology Co.,Ltd
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| Product Name |
Chlamydia Rapid Test |
| Formats | Strip(3mm)Device(4mm) |
| Place of Origen | China |
| Specimen | Vaginal Discharge |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | 25 device/box or 50 strip/Box |
| Storage | 2℃-30℃ |
For professional in vitro diagnostic use only.
The Chlamydia Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Chlamydia trachomatis in clinical specimens to aid in the diagnosis of Chlamydia infection.
Sensitivity
The Chlamydia Rapid Test Device has been evaluated with Chlamydia infected cells and specimens obtained from patients of STD clinics. The Chlamydia Rapid Test Device can detect 106org/mL Chlamydia infected cells. PCR is used as the reference method for the Chlamydia Rapid Test Device. Specimens were considered positive if PCR indicated a positive result. Specimens were considered negative if PCR indicated a negative result. The results show that Chlamydia Rapid Test Device has a high sensitivity relative to PCR.
Specificity
The Chlamydia Rapid Test Device uses an antibody that is highly specific for Chlamydia antigen in specimens. The results show the Chlamydia Rapid Test Device has a high specificity relative to PCR.
For Female Cervical Swab Specimens:
| Method | PCR | Total Results | |||
|
Chlamydia Rapid Test Device |
Results | Positive | Negative | RelativeSensitivity:87.5% | |
| Positive | 35 | 3 | 38 | RelativeSpecificity:96.5% | |
| Negative | 5 | 83 | 88 | RelativeAccuracy:93.7% | |
| Total Results | 40 | 86 | 126 | ||
For Male Urine Specimens:
| Method | PCR | Total Results | |||
|
Chlamydia Rapid Test Device |
Results | Positive | Negative | RelativeSensitivity:87.5% | |
| Positive | 21 | 1 | 22 | RelativeSpecificity:98% | |
| Negative | 3 | 50 | 53 | RelativeAccuracy:94.7% | |
| Total Results | 24 | 51 | 75 | ||
For Male Urethral Swab Specimens:
| Method | PCR | Total Results | |||
|
Chlamydia Rapid Test Device |
Results | Positive | Negative | RelativeSensitivity:82.7% | |
| Positive | 43 | 6 | 49 | RelativeSpecificity:93.9% | |
| Negative | 9 | 93 | 102 | RelativeAccuracy:90.1% | |
| Total Results | 52 | 99 | 151 | ||
Chlamydia trachomatis is the most common cause of sexually transmitted venereal infection in the world. It is composed of elementary bodies (the infectious form) and reticulate or inclusions bodies (the replicating form). Chlamydia trachomatis has both a high prevalence and asymptomatic carriage rate, with frequent serious complications in both women and neonates. Complications of Chlamydia infection in women include cervicitis, urethritis, endometritis, pelvic inflammatory disease (PID) and increased incidence of ectopic pregnancy and infertility.1 Vertical transmission of the disease during parturition from mother to neonate can result in inclusion conjunctivitis pneumonia. In men, complications of Chlamydia infection include urethritis and epididymitis. At least 40% of the nongonococcal urethritis cases are associated with Chlamydia infection. Approximately 70% of women with endocervical infections and up to 50% of men with urethral infections are asymptomatic. Traditionally, Chlamydia infection has been diagnosed by detection of Chlamydia inclusions in tissue culture cells. Culture method is the most sensitive and specific laboratory method, but it is labor intensive, expensive, long (48-72 hours) and not routinely available in most institutions.
The Chlamydia Rapid Test Device is a rapid test to qualitatively detect the Chlamydia antigen from clinical specimens, providing results in 10 minutes. The test utilizes antibody specific for Chlamydia to selectively detect Chlamydia antigen from clinical specimens.