Mycoplasma genitalium / Mycoplasma hominis Multiplex PCR kit

REF 85-01 Form S
REF 85-02 Form T

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	103 copies of M. genitalium, M. hominis genomic DNA per 1 mL (i.e. 10 copies of genomic DNA per reaction)
Controls included in the kit	• 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 possible
Approval	for in-vitro Diagnostics, CE IVD

Format	Format S	Format T
Kit Size	• REF 85-01, 112 tests • REF 85-01-56, 56 tests	• REF 85-02, 112 tests • REF 85-02-56, 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
Kit content	PCR-Mix M. genitalium, M.hominis, Form S, Taq DNA-polymerase, Positive Control, Internal Control, Negative Control	PCR-Mix M. genitalium, M. hominis, Form Т, Taq DNA-polymerase, Positive Control, Internal Control, Negative Control
Validated Thermocycler	Bio-Rad CFX96 Roche Light Cycler 96 DNA-Technology DTprime, DTlite, SaCycler	Qiagen Rotor-Gene Q, Rotor-Gene 3000/6000