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FlexStarยฎ UP & MH PCR Detection Mix 1.5

Intended use

The FlexStarยฎ UP & MH PCR Detection Mix 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection and differentiation of Ureaplasma parvum and Mycoplasma hominis specific DNA in human urine and human genital swab specimens collected in transport medium.

The FlexStarยฎ UP & MH PCR Detection Mix 1.5 is intended to be used as an aid for diagnosis of Ureaplasma parvum and Mycoplasma hominis infection.

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

Specifications

Key features

  • Qualitative detection and differentiation of Ureaplasma parvum and Mycoplasma hominis specific DNA
  • Parallel detection of both pathogens in a single reaction
  • Includes No Template Control (NTC) and Positive Control (PC)
  • To be used with the FlexStarยฎ (RT-)PCR Amplification Mix 1.5 and the AltoStarยฎ Internal Control 1.5
  • CE-IVD* markedย in vitroย diagnostic test
  • Analytical sensitivity reported in copies/ml

 

Limit of Detection (LoD)

LoD UP urineย  ย  ย  ย  315 copies/ml

LoD MH urineย  ย  ย  ย 755 copies/ml

LoD UP genital swab specimens in transport medium ย  ย  ย  ย  128 copies/ml

LoD MH genital swab specimens in transport medium ย  ย  ย  143 copies/ml
 

Sample types

The following sample types are validated for use with the FlexStarยฎ UP & MH PCR Detection Mix 1.5:

 

Human urine

Human genital swab specimens in transport medium

 

For use with

CFX96โ„ข Deep Well Dx System (Bio-Rad)

CFX96โ„ข Dx System (Bio-Rad)

QuantStudioโ„ข 5 Real-Time PCR System (Applied Biosystems)

Rotor-Geneยฎย Q5/6 plex Platform (QIAGEN)

 

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

Order No
FS0181543
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 FlexStarยฎ UP & MH PCR Detection Mix 1.5
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Associated documents FlexStarยฎ UP & MH PCR Detection Mix 1.5
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Manuals FlexStarยฎ UP & MH PCR Detection Mix 1.5
Language
FlexStarยฎ UP & MH PCR Detection Mix 1.5 - DE
Language: German
Date: 2026-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStarยฎ UP & MH PCR Detection Mix 1.5 - EN
Language: English
Date: 2026-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStarยฎ UP & MH PCR Detection Mix 1.5 - ES
Language: Spanish
Date: 2026-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStarยฎ UP & MH PCR Detection Mix 1.5 - FR
Language: French
Date: 2026-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStarยฎ UP & MH PCR Detection Mix 1.5 - IT
Language: Italian
Date: 2026-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStarยฎ UP & MH PCR Detection Mix 1.5 - PL
Language: Polish
Date: 2026-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStarยฎ UP & MH PCR Detection Mix 1.5 - PT
Language: Portuguese
Date: 2026-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
Associated documents FlexStarยฎ UP & MH PCR Detection Mix 1.5
Language
Type of document
FlexStarยฎ UP & MH PCR Detection Mix 1.5 - DE - DoC
Language: German
Date: 2026-05-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStarยฎ UP & MH PCR Detection Mix 1.5 - EN - DoC
Language: English
Date: 2026-05-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStarยฎ UP & MH PCR Detection Mix 1.5 - ES - DoC
Language: Spanish
Date: 2026-05-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStarยฎ UP & MH PCR Detection Mix 1.5 - FR - DoC
Language: French
Date: 2026-05-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStarยฎ UP & MH PCR Detection Mix 1.5 - IT - DoC
Language: Italian
Date: 2026-05-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStarยฎ UP & MH PCR Detection Mix 1.5 - PT - DoC
Language: Portuguese
Date: 2026-05-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD