Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
page
post
product
Home / FlexStar® / FlexStar® MG & UU & TV PCR Detection Mix 1.5
Go back

FlexStar® MG & UU & TV PCR Detection Mix 1.5

Intended use

The FlexStar® MG & UU & TV PCR Detection Mix 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection and differentiation of Mycoplasma genitalium, Ureaplasma urealyticum and Trichomonas vaginalis specific DNA in human urine and human genital swab specimens collected in transport medium.

The FlexStar® MG & UU & TV PCR Detection Mix 1.5 is intended to be used as an aid for diagnosis of Mycoplasma genitalium, Ureaplasma urealyticum and Trichomonas vaginalis infection.

Validated for use with the AltoStar® Automation System AM16 for nucleic acid extraction, the AltoStar® Internal Control 1.5 and the FlexStar® (RT-)PCR Amplification Mix 1.5.

 

Specifications

Key features

  • Qualitative detection and differentiation of Mycoplasma genitalium, Ureaplasma urealyticum and Trichomonas vaginalis specific DNA
  • Parallel detection of all pathogens in a single reaction
  • Includes No Template Control (NTC) and Positive Control (PC)
  • To be used with the FlexStar® (RT-)PCR Amplification Mix 1.5 and the AltoStar® Internal Control 1.5
  • CE-IVD* marked in vitro diagnostic test
  • Analytical sensitivity reported in copies/ml
 

Limit of Detection (LoD)

LoD MG urine        135 copies/ml

LoD UU urine         259 copies/ml

LoD TV urine          408 copies/ml

LoD MG genital swab specimens in transport medium         87 copies/ml

LoD UU genital swab specimens in transport medium          207 copies/ml

LoD TV genital swab specimens in transport medium           174 copies/ml

 

Sample types

The following sample types are validated for use with the FlexStar® MG & UU & TV PCR Detection Mix 1.5:

 

Human urine

Human genital swab specimens in transport medium

 

For use with

CFX96™ Deep Well Dx System (Bio-Rad)

CFX96™ Dx System (Bio-Rad)

QuantStudio™ 5 Real-Time PCR System (Applied Biosystems)

Rotor-Gene® Q5/6 plex Platform (QIAGEN)

 

* according to Regulation (EU) 2017/746 (IVDR).

Order No
FS0171543
Rxns
96
Transportation
Dry ice
Regulatory status
CE-IVD

Products not licensed with Health Canada and not FDA cleared or approved. Kits not available in all countries.

 

Manuals FlexStar® MG & UU & TV PCR Detection Mix 1.5
Download
Associated documents FlexStar® MG & UU & TV PCR Detection Mix 1.5
Download
Contact sales

Find your responsible sales representative.

Contact
Contact order processing

Order reagents, kits, instruments and implementation equipment for your workflow and laboratory routine.

Contact
Manuals FlexStar® MG & UU & TV PCR Detection Mix 1.5
Language
FlexStar® MG & UU & TV PCR Detection Mix 1.5 - DE
Language: German
Date: 2026-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® MG & UU & TV PCR Detection Mix 1.5 - EN
Language: English
Date: 2026-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® MG & UU & TV PCR Detection Mix 1.5 - FR
Language: French
Date: 2026-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® MG & UU & TV PCR Detection Mix 1.5 - IT
Language: Italian
Date: 2026-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® MG & UU & TV PCR Detection Mix 1.5 - PL
Language: Polish
Date: 2026-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® MG & UU & TV PCR Detection Mix 1.5 - PT
Language: Portuguese
Date: 2026-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® MG & UU & TV PCR Detection Mix 1.5 - ES
Language: Spanish
Date: 2026-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
Associated documents FlexStar® MG & UU & TV PCR Detection Mix 1.5
Language
Type of document
FlexStar® MG & UU & TV PCR Detection Mix 1.5 - DE - DoC
Language: German
Date: 2026-05-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® MG & UU & TV PCR Detection Mix 1.5 - EN - DoC
Language: English
Date: 2026-05-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® MG & UU & TV PCR Detection Mix 1.5 - ES - DoC
Language: Spanish
Date: 2026-05-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® MG & UU & TV PCR Detection Mix 1.5 - FR - DoC
Language: French
Date: 2026-05-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® MG & UU & TV PCR Detection Mix 1.5 - IT - DoC
Language: Italian
Date: 2026-05-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® MG & UU & TV PCR Detection Mix 1.5 - PT - DoC
Language: Portuguese
Date: 2026-05-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD