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Home / FlexStar® / FlexStar® CT & NG PCR Detection Mix 1.5
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FlexStar® CT & NG PCR Detection Mix 1.5

Intended use

The FlexStar® CT & NG PCR Detection Mix 1.5 is an in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection and differentiation of Chlamydia trachomatis and Neisseria gonorrhoeae specific DNA in human urine and human genital swab specimens collected in transport medium.

The FlexStar® CT & NG PCR Detection Mix 1.5 is intended to be used as an aid for diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae 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 Chlamydia trachomatis and Neisseria gonorrhoeae specific DNA
  • Parallel detection of both pathogens in a single reaction
  • Dual-target detection for Chlamydia trachomatis (single channel) and Neisseria gonorrhoeae (separate channels) in accordance with guideline recommendations
  • 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 CT urine        99 copies/ml

LoD NG urine       206 copies/ml

LoD CT genital swab specimens in transport medium         118 copies/ml

LoD NG genital swab specimens in transport medium       117 copies/ml
 

Sample types

The following sample types are validated for use with the FlexStar® CT & NG 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
FS0161543
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® CT & NG PCR Detection Mix 1.5
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Associated documents FlexStar® CT & NG PCR Detection Mix 1.5
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Manuals FlexStar® CT & NG PCR Detection Mix 1.5
Language
FlexStar® CT & NG PCR Detection Mix 1.5 - DE
Language: German
Date: 2026-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® CT & NG PCR Detection Mix 1.5 - EN
Language: English
Date: 2026-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® CT & NG PCR Detection Mix 1.5 - ES
Language: Spanish
Date: 2026-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® CT & NG PCR Detection Mix 1.5 - FR
Language: French
Date: 2026-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® CT & NG PCR Detection Mix 1.5 - IT
Language: Italian
Date: 2026-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® CT & NG PCR Detection Mix 1.5 - PL
Language: Polish
Date: 2026-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® CT & NG PCR Detection Mix 1.5 - PT
Language: Portuguese
Date: 2026-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
Associated documents FlexStar® CT & NG PCR Detection Mix 1.5
Language
Type of document
FlexStar® CT & NG PCR Detection Mix 1.5 - DE - DoC
Language: German
Date: 2026-05-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® CT & NG PCR Detection Mix 1.5 - EN - DoC
Language: English
Date: 2026-05-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® CT & NG PCR Detection Mix 1.5 - ES - DoC
Language: Spanish
Date: 2026-05-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® CT & NG PCR Detection Mix 1.5 - FR - DoC
Language: French
Date: 2026-05-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® CT & NG PCR Detection Mix 1.5 - IT - DoC
Language: Italian
Date: 2026-05-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD
FlexStar® CT & NG PCR Detection Mix 1.5 - PT - DoC
Language: Portuguese
Date: 2026-05-04
Panel: Sexually transmitted infections (STI)
Regulatory status: CE-IVD