Hc2 CT-ID DNA Test

An in vitro nucleic Acid Hybridization Microplate Assay with signal Amplification using Microplate chemiluminescene for the Qualitative Detection of Chlamydia trachomatics (CT) DNA in cervical Specimen’s.

SUMMARY AND EXPLANATION

Chlamydiae are gram negative organisms with a two-phase life cycle comprising morphologically distinct infections and reproductive forms. The Chlamydia trachomatis genome is relatively small, measuring approximately base pairs. Once inside a host cell, elementary bodies assemble into membrane bound vacuoles to produce the metabolically active chlamydial reproductive forms. Chlamydiae have a membrane bound, genus-specific lipopolysaccharide that has served as a source of antigen for the production of diagnostic antibodies.

Conventional methods for the direct detection of Chlamydia trachomatis in clinical specimens include iodine or giemsa staining of the organism followed by microscopic evaluation or the more sensitive use of direct fluorescent antibody staining. The most widely accepted procedure for Chlamydia detection is the infection of McCoy cells in cell culture. Optimal cell culture has excellent sensitivity and specificity for the detection of Chlamydia, but is a complex, expensive and time-consuming procedure. Nucleic acid tests are also available for the detection of a variety of Chlamydia targets, including chromosomal DNA, Mrna, and the cryptic plasmid common to the vast majority of Chlamydia trachomatis strains.

PRINCIPLE OF THE PROCEDURE

The hc2 CT-ID DNA Test using Hybrid Capture 2 technology is a nucleic acid hybridization assay with signal amplification that a specific Chlamydia RNA probe. The resultant RNA:DNA hybrids are captured onto the surface of a microplate well coated with antibodies specific for RNA:DNA hybrids. Multiple conjugated antibodies bind to each captured hybrid resulting in substantial signal amplification. As the substrate is cleaved by the bound alkaline phosphatase, light is emitted, which is measured as relative units. On a luminometer.

The CT probe contains a probe mixture specifically chosen to eliminate or minimize cross-reactivity with DNA sequences from human cells, other bacterial species or Chlamydia species other than Chlamydia trachomatis. High volume sample-throughput testing with the hc2 CT-ID DNA Test can be performed utilizing a general use automated pipetting and dilution system referred to as the rapid capture system. To enable high volume sample-throughput testing, all the procedural steps of the assay are performed by the RCS, with the exception of specimen denaturation, chemiluminescent signal detection, and result reporting.