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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

Product formats

Format Format S Format T
Kit Size • REF 85-01, 112 tests
• REF 85-01-56, 56 tests
• REF 85-01-24, 24 tests
• REF 85-02, 112 tests
• REF 85-02-56, 56 tests
• REF 85-02-24, 24 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 Ò, 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