Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit

CE IVD

Product description

The Mycoplasma genitalium/Mycoplasma hominis Multiplex PCR kit is intended for fast qualitative Real-Time PCR detection of Mycoplasma genitalium and Mycoplasma hominis DNA in urethral swabs, endocervical and vaginal swabs and urine samples

Technical specification

Assay Principle	Real Time PCR test for detection of Mycoplasma genitalium, Mycoplasma hominis DNA
Test results	Qualitative
Sample material	Urethral swabs, endocervical and vaginal swabs and urine samples
Analytical Sensitivity	1000 copies of M. genitalium, M. hominis genomic DNA per 1 mL (i.e. 10 copies of genomic DNA per reaction)
Kit content	• PCR-Mix M. genitalium, M. hominis • Taq DNA-polymerase • Positive control • Negative control • Internal control
Steps	• DNA Extraction • PCR amplification • Data analysis and interpretation
Validated extraction methods	Multi DNA Extraction kit (Astra Biotech GmbH) Rapid DNA Extraction kit (Astra Biotech GmbH) Prime DNA/RNA 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 85-01, 112 tests • REF 85-01-56, 56 tests	• REF 85-02, 112 tests • REF 85-02-56, 56 tests	• REF 85-03, 112 tests • REF 85-03-56, 56 tests
Format Description	reaction mix under paraffin in PCR 0.1 mL low profile 8 tube strips; Taq DNA polymerase supplied in a separate tube	reaction mix under paraffin in PCR 0.2 mL regular profile reaction tubes; Taq DNA polymerase supplied in a separate tube	liquid reaction mix is in 1.5 mL tube
Validated Thermocycler	Bio-Rad CFX96 Roche Light Cycler 96 DNA-Technology DTprime, DTlite, SaCycler	Qiagen Rotor-Gene Q, Rotor-Gene 3000/6000	Qiagen Rotor-Gene Q, Rotor-Gene 3000/6000, CFX96, CFX96 Touch, DTprime, DTlite, SaCycler, Light Cycler 96

_{Vers. 2023_01}