Chlamydia Trachomatis IgM ELISA Kit
INTENDED USE
Human Chlamydia trachomatis IgM ELISA kit is a method intended for in-vitro quantitative detection of human IgM class antibodies to Chlamydia trachomatis (Chlamydia trachomatis-IgM) present in samples of plasma and serum. This assay has a minimum analytical sensitivity limit to a diagn. 83.3%.
BACKGROUND
Chlamydia trachomatis infections are one of the most frequent reported sexually transmitted infection (STI), especially within the United States. However, the majority of these chlamydial infections are asymptomatic, which can provide an ongoing reservoir for future infections. There are a large number of publications which have reported that untreated chlamydial infection can cause serious sequelae, such as pelvic inflammatory disease (PID), chronic pelvic pain and tubal infertility. The most common clinical manifestation of chlamydial infection found in men is urethritis, whereas in women it is cervicitis. Chlamydial infection during pregnancy have been linked to an increased risk of preterm labour, perinatal mortality and low birth weight. Until recently, one of the major hindrance in controlling chlamydial infections has been the lack any available specific, sensitive and inexpensive diagnostic test. Screening programs have also been undertaken in order to reduce the overall prevalence of chlamydial infection present within the tested population.
CHLAMYDIA TRACHOMATIS IGM ELISA KIT CONTENT
All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.
- Chlamydia trachomatis Coated Microplate (IgM).
- Cut-off Control.
- Negative Control.
- Positive Control.
- IgM Sample Diluent.
- Chlamydia trachomatis anti-IgM Conjugate.
- TMB Substrate Solution.
- Stop Solution.
- Washing Buffer (20x Conc.).
SENSITIVITY
The minimum detection sensitivity level of IgM class antibodies to Chlamydia trachomatis using current human Chlamydia trachomatis-IgM ELISA kit was to a diagn. 83.3%. The dynamic range for this assay is to a specific cut-off point.
ASSAY CHARACTERSTICS
– Chlamydia Trachomatis ELISA: IgM
– Positive: > 11 U
– Equivocal: 9 – 11 U
– Negative: < 9 U
– Cut-Off: 10 U
– Diagnostic Specificity: 100.00%
– Diagnostic Sensitivity: 88.89%
– Cross Reactivity: None
– Interferences: None
REFERENCES
- Detection of IgM antibodies against Chlamydia trachomatis by enzyme linked fluorescence immunoassay. J Clin Pathol. (1985) 38 (7): 733-9. Numazaki K., et al.
- Serum IgM to Chlamydia trachomatis in pregnancy: its usefulness for screening. Br J Biomed Sci. (2002) 59 (1): 30-4. Rastogi S., et al.
- Chlamydia trachomatis IgM seropositivity during pregnancy and assessment of its risk factors. Mymensingh Med J. (2014) 23 (1): 62-8. Rahman M., et al.
- Detection of IgM antibodies to Chlamydia trachomatis, Chlamydia pneumoniae, and Chlamydiapsittaci from Japanese infants and children with pneumonia. In Vivo. (1992) 6 (6): 601-4. Numazaki K., et al.
- Adverse foetal outcome in specific IgM positive Chlamydia trachomatis infection in pregnancy. Indian J Med Res. (1991) 94: 420-3. Jain A., et al.
ADDITIONAL INFORMATION
- Full Name: Chlamydia Trachomatis IgM ELISA Kit
- Reactivity: Human
- Sample Type: Plasma, Serum
- Sensitivity: diagn. 83.3%