Infection Disease Chlamydia Rapid Test with CE0123 certificate
uncut sheet
| Product Name | Chlamydia Rapid Test uncut sheet |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Vaginal Discharge |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | uncut sheet |
| 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.
PRINCIPLE
The Chlamydia Rapid Test Device is a qualitative, lateral flow
immunoassay for the detection of Chlamydia antigen from clinical
specimens.
In this test, antibody specific to the Chlamydia antigen is coated
on the test line region of the strip. During testing, the extracted
antigen solution reacts with an antibody to Chlamydia that is
coated onto particles. The mixture migrates up to react with the
antibody to Chlamydia on the membrane and generate a red line in
the test region. The presence of this red line in the test region
indicates a positive result, while its absence indicates a negative
result. To serve as a procedural control, a red line will always
appear in the control region indicating that proper volume of
specimen has been added and membrane wicking has occurred.
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 | |
