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Neisseria gonorrhoeae PCR kit

CE IVD

Product description

The Neisseria gonorrhoeae PCR kit is provided for fast and qualitative detection of Neisseria gonorrhoeae DNA in samples extracted from urethral swab specimens, endocervical and vaginal smears, urine samples, prostatic fluid specimens and other human body fluids and tissue samples by means of Real-Time PCR for diagnosis of Neisseria gonorrhoeae presence.

 

Technical specification

Assay Principle Real-time PCR kit for detection of Neisseria gonorrhoeaeinfection
Test results Qualitative
Sample material Total DNA isolated from urethral swabs, endocervical and vaginal smears, urine, prostatic fluid and other human body fluids and tissue samples
Analytical Sensitivity 180 copies of genomic DNA of Neisseria gonorrhoeae/ mL
Controls included in the kit • positive control
• negative control
• internal control for monitoring DNA extraction and PCR amplification steps
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)

Storage -18…-30°C, transportation for 7 days at room temperature possible
Approval For in-vitro diagnostics, CE

 

Product formats

Format Format S Format T
REF No. REF 84-03 REF 84-04
Kit Size 112 Tests 112 Tests
Format Description liquid reaction mix aliquoted into 0.2 mL low profile 8-tube strips liquid reaction mix aliquoted into 0.2 mL regular profile reaction tubes
Kit Content PCR-Mix S-NG , Taq DNA-polymerase, liquid reaction mix aliquoted into 0.2 mL regular profile reaction tubes PCR-Mix T-NG, Taq DNA-polymerase, liquid reaction mix aliquoted into 0.2 mL regular profile reaction tubes
Validated Thermocycler CFX96, Light Cycler 96 (LC 96), DTprime, DTlite, SaCycler Rotor-Gene Q, Rotor-Gene 3000/6000

 

Gonorrhea

An infection with Neisseria gonorrhoeae, 0.6 µm - 0.8 µm gram-negative diplococci, is called gonorrhoea. It is one of the most common bacterial STDs. The average age of those affected is 30 years. The incubation period is 1-14 days. Due to the alarming increase in antibiotic resistance to penicillins, for example, a combination of at least two different antibiotics (cefixim, ceftriaxon) is usually used to treat the disease. If gonorrhoea remains undetected, disseminated gonococcal infection can cause chronic inflammation such as inflammation of the mucous membrane of the urethra, cervix, rectum, pharynx and conjunctiva of the eye. Adhesions, persistent abdominal pain and infertility are also known consequences.

A typical indication of a gonorrhea infection of a man is a purulent discharge from the urethra in the morning associated with pain. Women are mostly symptom-free. In some cases, however, vaginal discharge and pain during urination also occurred in infected women. During pregnancy and childbirth the pathogens can be transmitted to the child, which, if left untreated, can lead to blindness of the newborn, but also to premature birth and septic miscarriage.