Chlamydia Trachomatis IgM ELISA Kit

Full Name: Chlamydia Trachomatis IgM ELISA Kit
Reactivity: Human
Sample Type: Plasma, Serum
Sensitivity: diagn. 83.3%

BACKGROUND

Chlamydia trachomatis is a gram-negative obligate intracellular bacterium that is a common sexually transmitted infection. It has a distinct biphasic lifecycle consisting of infectious elementary bodies and replicative reticulate bodies. The elementary body is a small, spherical, spore-like structure that attaches to and enters host epithelial cells. Once inside, elementary bodies differentiate into reticulate bodies that proliferate by binary fission within a membrane-bound inclusion vacuole. Reticulate bodies convert back into elementary bodies that are released from the cell to infect new hosts.

C. trachomatis can infect columnar epithelial cells in the urethra and reproductive tract. It evades host defenses by remaining inside cells and preventing lysosomal fusion with the inclusion. C. trachomatis has a type III secretion system that injects effector proteins into the host cell to aid infection. Some strains have a cryptic plasmid that may encode virulence factors. Infection often causes inflammation as immune cells respond to infected epithelial cells.

C. trachomatis includes different serovars that cause specific diseases. Serovars A-C cause ocular infections like trachoma, the leading cause of preventable blindness worldwide. Serovars D-K infect the urogenital tract and cause nongonococcal urethritis, cervicitis, pelvic inflammatory disease, and infertility. Lymphogranuloma venereum is caused by serovars L1-L3. Vertical transmission from mother to baby can result in infant pneumonia and conjunctivitis. Genital infections are generally asymptomatic and promote further spread.

INTENDED USE

Human Chlamydia trachomatis IgM ELISA kit is a method intended for in-vitro detection of human IgM class antibodies against 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%.

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 human IgM class antibodies to Chlamydia trachomatis using current 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

– 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.

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