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Sexually Transmitted Infections(STIs) Screening Kit (Fluorescence PCR Method)

  • 14 Full STIs Screening Kit
  • Freeze-dried Reagents
  • Fluorescence PCR method
  • Vaginal Swab and Urine Specimens
  • Can Be Used for One-step Detection
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  • PR2026-ST01

  • Bioteke


Comprehensive STIs Screening Kit

Multiplex Fluorescent PCR for Accurate&Efficient Pathogen Detection


(FOR PROFESSIONAL USE ONLY)



INTENDED USE

       The kit is used for qualitative screening test of 14 common STIs pathogens nucleic acid in vaginal swab and urine specimens from sexually transmitted infection suspected patients.

PRINCIPLE
  • This kit is a multiplex fluorecent probe-based Taqman® qPCR assay system. Specific primers and probes are designed for the detection of specific genes of 14 common STI/STD pathogens.

  • Internal control(IC) serves as the monitor to confirm successful extraction and identify possible PCR inhibition for the entire testing system to prevent false negative detection results.In order to avoid aerosol contamination of the amplified products, the UDG enzyme /dUTP system was added to the amplification system to effectively degrade the amplified products and avoid false positive results.

  • This kit is a fully premix freeze-dried system. Taq enzyme, UDG enzyme, reaction buffer, specific primers and probes required for amplification are all lyophilized in PCR tubes. Detection can be performed directly after adding dissolving solution and extracted nucleic acid.



Detection Target

          




Targets

Trichomonas vaginalis

          




Targets

Ureaplasma urealyticum
Neisseria gonorrhoeaeUreaplasma parvum
Chlamydia trachomatisMycoplasma hominis
Gardnerella vaginalisMycoplasma genitalium
Haemophilus ducreyiTreponema pallidum
Candida albicans

Herpes simplex virus type 1

Streptococcus agalactiae

Herpes simplex virus type 2



KIT COMPONENTS


Components
8 samples/kit
24 samples/kitIngredient
ST01 Lyophilized Reagent8*4 strip tubes
24*4 strip tubes

Specific primer&probes,

 dNTP/dUTP, Mg2+, Taq polymerase and UDG enzyme

STI Lysis Buffer1 mL*1 tube
5 mL*1 tubeSurface active agent, balanced salt solution
One Test Glass Beads8 tubes*1 bag
8 tubes*3 bagsGlass beads
STI Positive Control400 μL*1 tube
400 μL*1 tubePlasmid containing every target gene sequence
STI Negative Control400 μL*1 tube400 μL*1 tubePlasmid containing internal control sequence
Dissolving Solution1 mL*1 tube1 mL*2 tubesStabilizer


STORAGE & SHELF LIFE


  • Store frozen at -20±5℃.

  • The kit can be transported at room temperature (≤ 1 month).

  • Repeated freezing and thawing should not exceed 7 times.

  • Valid for 12 months(From the QC passed).


EQUIPMENTS & MATERIALS REQUIRED


  • Disposable powder free gloves and other personal protective equipment. 

  • Pipettes (adjustable) and Sterile pipette tips. 

  • Vaginal swabs/urine sample collection device.

  • 1.5 mL centrifuge tubes and racks. 

  • Bench top centrifuge for centrifuge tubes and PCR tubes. 

  • Vortex mixer.(Power≥40w) 

  • Centrifuge tube holder for vortex mixer. (not necessary,can replace part of manual operation) 

  • Metal bath/water bath.(1.5mL centrifuge tube,95℃) 

  • Real-time PCR instrument with FAM/VIC/ROX/CY5 fluorescence channels.(Such as ABI7500, Bio-rad CFX96, QuantStudio, SLAN-96S, BTK-96, BTK-16)


PERFORMANCE SPECIFICATIONS


  • Detection limitation: 1000 Copies/mL. 

  • Precision: The coefficient of variation (CV, %) of Ct value of within-batch/between-batch precision is ≤ 5%.

  • Accuracy: The conformity rate of negative/positive reference: 100%. 

  • Specificity:The target organisms had been analyzed in silico for potential cross-reactivity with the primers or probe sequences.Homology with other species is all below 90%. Specificity analysis showed that there is no cross reaction between the pathogens detected by this kit.


BIOTEKE SOLUTION

▇ Bioteke uses a fully automated nucleic acid extraction and PCR testing device, coupled with a patented STI screening kit, to achieve a one-step diagnosis of “sample in, result out”

 

▇ Features

1. Fast & Simple

       No need to extract nucleic acid, the sample can be directly put into the machine after adding lysis buffer. The whole process only takes 75-90 minutes.

2. Accurate & Efficient

       Reduce manual operation errors and shorten detection time.

3. Reduce Cost

       Reduce experimental consumables and labor costs.

4. Flexible & Convenient

       Can be used for small batch testing and instant testing(POCT).

5. Security & Compliance

       The product has IVD CE / MSDS / ISO 13485 certificates.


Click here to learn more

 Fully Automated Sexually Transmitted Infection(STI) Screening Solution


Watch the video of operation process 



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