CLIA Chlamydia trachomatis IgG

Description

Chlamydia is caused by the gram-negative, obligate intracellular bacterium Chlamydia trachomatis . Globally, it is the most prevalent sexually transmitted bacterial infection. The organism causes genitourinary infections in women and men, the disease often remains asymptomatic. Sexually active young people between 15 and 30 years of age are most at risk of chlamydia. The most common complications are pelvic inflammatory disease (PID) and salpingitis, conditions that can lead to infertility in both men and women and extra-uterine pregnancies. Cervical chlamydia infection is currently considered to be one of the risk factors for uterine cervix carcinoma.

Once detected, the infection is easily treated by a short course of antibiotic therapy.

Technical data

• Assay time: 30 min
• Assay stability: 30 days on board stability / In use stability until the expiration date at storage temperature 2-8 °C
• Sample matrix: Serum, Plasma
• Sample volume: 10 μL
• Measuring range: 0,1-320 U/ml
• Complementary products: Anchor® Tips, Stackable Cuvette, KleeYa Trigger Pack, KleeYa Wash buffer
• Note: The kits are CE-IVD certified and intended for professional use.

Specifications

• Catalog Number: CL-ChtG100
• Size: 100 tests
• Regulatory status: CE IVD
• Clinical topic: Infectious Diseases
• Diagnostic panel: Sexually Transmitted Infections (STIs)
• Producer: TestLine Clinical Diagnostics s.r.o.

References

• 7512399,2294050,3724806,10719781,11905590,12572892,15184423,8030740,7035557,2466791
• Cates W Jr, Wasserheit JN. Genital chlamydial infections: epidemiology and reproductive sequelae. Am J Obstet Gynecol. 1991 Jun;164(6 Pt 2):1771-81. doi: 10.1016/0002-9378(91)90559-a. PMID: 2039031.
• Centers for Disease Control and Prevention. Recommendations for the laboratory-based detection of Chlamydia trachomatis and Neisseria gonorrhoeae– 2014. MMWR Recomm Rep. 2014 Mar 14;63(RR-02):1-19. PMID: 24622331; PMCID: PMC4047970.
• Nwokolo NC, Dragovic B, Patel S, Tong CY, Barker G, Radcliffe K. 2015 UK national guideline for the management of infection with Chlamydia trachomatis. Int J STD AIDS. 2016 Mar;27(4):251-67. doi: 10.1177/0956462415615443. Epub 2015 Nov 4. PMID: 26538553.
• Peipert JF. Clinical practice. Genital chlamydial infections. N Engl J Med. 2003 Dec 18;349(25):2424-30. doi: 10.1056/NEJMcp030542. PMID: 14681509.
• Blas MM, Canchihuaman FA, Alva IE, Hawes SE. Pregnancy outcomes in women infected with Chlamydia trachomatis: a population-based cohort study in Washington State. Sex Transm Infect. 2007 Jul;83(4):314-8. doi: 10.1136/sti.2006.022665. Epub 2007 Mar 7. PMID: 17344249; PMCID: PMC2598687.
• Zhu H, Shen Z, Luo H, Zhang W, Zhu X. Chlamydia Trachomatis Infection- Associated Risk of Cervical Cancer: A Meta-Analysis. Medicine (Baltimore). 2016 Mar;95(13):e3077. doi: 10.1097/MD.0000000000003077. PMID: 27043670; PMCID: PMC4998531.
• Silva J, Cerqueira F, Medeiros R. Chlamydia trachomatis infection: implications for HPV status and cervical cancer. Arch Gynecol Obstet. 2014 Apr;289(4):715-23. doi: 10.1007/s00404-013-3122-3. Epub 2013 Dec 18. PMID: 24346121.

• Reagent Cartridge with specific reagents for the assay
• magnetic particles
• calibrators