Hangzhou Aichek Medical Technology Co.,Ltd
Hangzhou Aichek Medical Technology Co.,Ltd
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| 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.
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.
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 | ||