Infection Disease Chlamydia Rapid Test with CE certificate Test
Device
| 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.
INTENDED USE
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 | |
SUMMARYChlamydia 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.
