CE IVD
Product description
The Trichomonas vaginalis is provided for fast and qualitative detection of Trichomonas vaginalis (TV) DNA in 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 trichomoniasis.
Technical specification
Assay Principle |
Real-time PCR kit for detection of trichomoniasis |
Test results |
Qualitative |
Type of 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 |
480 copies of genomic DNA of Trichomonas vaginalis/ mL |
Kit content |
• PCR-Mix T. vaginalis • Taq DNA-polymerase • 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)
Magnetic DNA/RNA Auto Extraction kit (Astra Biotech GmbH)
|
Storage |
-18…-30°C, transportation for 7 days at room temperature acceptable |
Approval |
CE IVD |
Format |
Format S |
Format T |
Format F |
Kit Size |
REF 84-05, 112 Tests |
REF 84-06 , 112 Tests |
REF 84-02 , 112 Tests |
Format Description |
liquid reaction mix aliquoted into 0.1 mL low profile
8-tube strips; DNA polymerase in a separate tube |
liquid reaction mix aliquoted into 0.2 mL regular profile reaction tubes; DNA polymerase in a separate tube |
liquid PCR-Mix-Tv reaction mix is in 1.5 mL tube |
Validated Thermocycler |
CFX96, Light Cycler 96 (LC 96), DTprime, DTlite, SaCycler, QuantStudio 5 (96-well 0.1 mL Block) |
Rotor-Gene Q, Rotor-Gene 3000/6000, CFX96, DTprime, DTlite, SaCycler, QuantStudio 5 (96-well 0.2 mL Block) |
Rotor-Gene Q, Rotor-Gene 3000/6000, CFX96, LC 96, DTprime, DTlite, SaCycler, QuantStudio 5 (96-well 0.1 mL Block, 96-well 0.2 mL Block) |
Trichomoniasis
Infections with Trichomonas vaginalis, 8 µm to 25 µm parasitic protozoan, are known as trichomoniasis. Trichomoniasis is the most common curable STD with incubation time of 5 to 28 days.
In women T.v. especially colonizes the vaginal mucous membrane whereas the mucous membrane of prostate and urinary tract are affected in men.
The pathogen is transmitted through sexual intercourse, but not by smear infections.
Common symptoms reported for men are burning and itching associated with urination and ejaculation and discharge.
Women are more often affected than men. They claim about vaginitis with itching and burning, foamy discharge as well as dysuria.
Metronidazole or nimorazole are used among others for medical treatment of trichomoniasis.
Vers. 2023_01