Chlamydia trachomatis PCR Kit


	Chlamydia trachomatis PCR Kit Neisseria gonorrhoeae PCR kit Trichomonas vaginalis PCR kit Cytomegalovirus PCR kit Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit Ureaplasma urealyticum / Ureaplasma parvum Multiplex PCR kit Human papillomavirus 16/18 Genotyping PCR kit

CE ₀₄₈₃ IVD

Product description

The Chlamydia trachomatis PCR kit is provided for fast and qualitative detection of Chlamydia trachomatis DNA in samples extracted from urethral swab specimens, endocervical and vaginal smears, urine samples, by means of Real-Time PCR for diagnosis of C. trachomatis presence.

Technical specification

Assay Principle	Real-time PCR kit for detection of chlamydiosis
Test results	Qualitative
Sample material	Total DNA can be extracted from urethral swab specimens, endocervical and vaginal smears, urine samples
Analytical Sensitivity	600 copies of genomic DNA of Chlamydia trachomatis/ mL
Kit content	• PCR-Mix C. trachomatis • Taq DNA polymerase • Positive control • Internal control • Negative control
Steps	• DNA Extraction • Real-time PCR • Analysis of data
Validated extraction methods	Multi DNA Extraction kit (Astra Biotech GmbH) Rapid DNA Extraction kit (Astra Biotech GmbH) Magnetic DNA/RNA Auto Extraction kit (Astra Biotech GmbH)
Storage	-18…-30°C, transportation for 7 days at room temperature acceptable
Approval	CE IVD

Product formats

Form	Form S	Form T	Form F
Kit Size	• REF 84-09, 112 tests • REF 84-09-56, 56 tests	• REF 84-10, 112 tests • REF 84-10-56, 56 tests	• REF 84-11, 112 tests • REF 84-11-56, 56 tests
Format Description	Liquid reaction mixes aliquoted in 0.1mL low profile 8-well strips	Liquid reaction mixes aliquoted in 0.2mL regular profile tubes	Liquid reaction mix in a 1.5mL vial
Validated Thermocyclers	CFX96, CFX96 Touch, Light Cycler 96 (LC 96), DTprime, DTlite, SaCycler, QuantStudio 5 (96-well 0.1 mL block)	Rotor-Gene Q, Rotor-Gene 3000/6000, QuantStudio 5 (96-well 0.2 mL block)	Rotor-Gene Q, Rotor-Gene 3000/6000, CFX96, CFX96 Touch, Light Cycler 96, DTprime, DTlite, SaCycler, QuantStudio 5 (96-well 0.1 mL block, 96-well 0.2 mL block)

Chlamydioses

Infections with members of the family Chlamydiaceae (Chlamydia), 0,2-0,4 μm Gram-negative bacteria, are called chlamydioses.

Chlamydia infects epithelial cells of the urogenital tract or respiratory tract in humans and is one of the largest causes of bacterial urogenital infections worldwide. One of the most prominent representatives is Chlamydia trachomatis.

An urogenital infection with chlamydia is completely symptomless in about 70% to 80% of women and in 50% of men. In women, such an infection can lead to a painful inflammation of the female genital tract, which can result in perihepatitis and sealing of the fallopian tubes. This in turn may be the reason for the absence of pregnancy of the affected patients and be remedied only in about 20% to 60% of cases by means of surgery. In men, an acute chlamydial infection can lead to inflammation of the genitourinary tract, characterized by pain on urination and, if left untreated, to inflammation of the epididymis. An influence on the fertility of the man is also considered possible.

For these reasons, the early diagnosis of an acute chlamydial infection in women and men is of crucial importance in order to treat them and their sexual partner in time with antibiotics.

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