STI-Q Real-Time PCR Kit

Product Overview

Sexually transmitted infections (STIs) remain one of the most significant publichealth challenges worldwide. Many STI pathogens produce similar clinicalsymptoms, while a large proportion of infections remain asymptomatic, contributingto delayed diagnosis and continued disease transmission. Untreated infections maylead to infertility, pelvic inflammatory disease, adverse pregnancy outcomes,neonatal complications, chronic urogenital disorders, and increased susceptibilityto other infections.

The STI-Q Real-Time PCR Kit from Genes2Me is a comprehensiveCE-IVD multiplex molecular diagnostic assay designed for the simultaneousqualitative detection of thirteen clinically important STI pathogens. The assay combinesadvanced real-time PCR technology with optimized multiplex chemistry to providerapid, reliable, and accurate pathogen detection directly from clinic

Targets:

Chlamydia trachomatis, Neisseriagonorrhoeae, Trichomonas vaginalis,Ureaplasma urealyticum, Ureaplasmaparvum, Mycoplasma hominis,Mycoplasma genitalium, Treponemapallidum, HSV-1 & HSV-2, Candidaalbicans, Haemophilus ducreyi,Toxoplasma gondii

Technology:

Multiplex Real-Time PCR (TaqMan)

Detection:

Qualitative (Detected / Not Detected)

Sample Type:

Blood, Urine, Swab Specimens

Certification:

CE-IVD

How the Assay Works

The STI-Q assay utilizes multiplex TaqMan-based Real-Time PCR technology in athree-tube format. Tube 1 detects Chlamydia trachomatis, Neisseria gonorrhoeae,and Trichomonas vaginalis. Tube 2 detects Ureaplasma urealyticum, Ureaplasmaparvum, and Mycoplasma hominis. Tube 3 detects Mycoplasma genitalium,Treponema pallidum, and HSV-1/HSV-2. Tube 4 detects Candida albicans,Haemophilus ducreyi, Toxoplasma gondii. Fluorescently labeled probes enabletarget-specific detection, while internal controls monitor extraction quality andamplification efficiency. Positive and negative controls validate assay integrity andhelp ensure reliable results in every run.

Why Molecular Testing Matters for STI Detection

Many sexually transmitted infections present with overlapping clinicalmanifestations, making diagnosis based solely on symptoms unreliable. Conventional methods such as culture, microscopy, and serological testing may lacksensitivity, require prolonged turnaround times, or fail to detect co-infections. Molecular testing enables direct pathogen detection with superior sensitivity andspecificity, facilitating earlier diagnosis, targeted treatment, improved antimicrobialstewardship, and better patient outcomes.

Key Features & Benefits

Comprehensive Multiplex Detection

Simultaneous detection of thirteen major STIpathogens in a single streamlined workflow, reducing testing complexity andimproving laboratory efficiency.

High Sensitivity & Specificity

Advanced TaqMan chemistry enables accuratedetection of clinically relevant pathogens, even in samples containing low targetconcentrations.

Detection of Mixed Infections

Detection of Mixed Infections Supports identification of multiple pathogens fromthe same specimen, providing a more complete clinical picture.

Robust Internal Control System

Integrated internal controls validate extraction quality, amplification efficiency, and PCR performance in every reaction.

Positive & Negative Controls Included

Positive & Negative Controls Included Ensures assay integrity, contamination monitoring, and confidence in result interpretation.

Rapid Turnaround Time

Rapid Turnaround Time Provides timely molecular results, enabling earlier diagnosis, treatment initiation, and patient management.

Optimized Three-Tube Design

Optimized Three-Tube Design Balances extensive multiplexing with reliable analytical performance and straightforward workflow implementation.

Compatible with major PCR platforms

Platform Compatibility Validated on QuantStudio 5, Bio-Rad CFX96, Roche LightCycler 480, and RapiCycler 96 systems.

Applications

Clinical & Hospital Laboratories: Enables rapid and accurate molecular detection of multiple sexually transmitted pathogens in routine diagnostic workflows. The multiplex design reduces testing burden while supporting timely clinical decisions and improved patient management.
Sexual Health & STI Clinics: Provides comprehensive screening for symptomatic and asymptomatic individuals. Simultaneous detection of multiple pathogens supports faster diagnosis, treatment planning, partner management, and infection control strategies.
Fertility & Reproductive Health Centres: Supports investigation of infertility, recurrent pregnancy loss, pelvic inflammatory disease, and other reproductive complications associated with sexually transmitted pathogens such as Chlamydia, Mycoplasma, and Ureaplasma species.
Maternal & Prenatal Screening: Facilitates early identification of infections that may contribute to adverse pregnancy outcomes, congenital infections, premature rupture of membranes, preterm birth, and neonatal complications, enabling timely clinical intervention.
Infectious Disease Laboratories: Provides a sensitive and specific molecular tool for confirmation of STI pathogens, particularly in cases where conventional diagnostic methods may be inconclusive or insufficiently sensitive.
Differential Diagnosis: Assists clinicians in distinguishing among multiple pathogens that present with overlapping urogenital symptoms, helping to avoid misdiagnosis and enabling targeted therapeutic decisions.
High-Risk Population Screening: Suitable for screening programs involving high-risk populations, including individuals with multiple sexual partners, immunocompromised patients, and populations with increased STI prevalence.
Research & Epidemiological Studies: Useful for clinical research, pathogen prevalence assessments, antimicrobial resistance monitoring programs, and molecular epidemiology studies focused on sexually transmitted infections.
Public Health & Surveillance Programs: Supports epidemiological monitoring, prevalence studies, screening initiatives, and disease control programs by enabling reliable identification of multiple STI pathogens within target populations.

Analytical Performance

Comprehensive multiplex detection of 12 clinically relevant STI pathogens in a single assay, enabling efficient differential diagnosis.
Clinical sensitivity 98% and clinical specificity 98%.
Analytical sensitivity (Limit of Detection): 350 copies/mL
Positive result cut-off: Ct ≤35, ensuring reliable qualitative detection of target pathogens.
Excellent linearity across 10²–10⁵ copies/reaction with R² ≥0.98 and PCR efficiency between 90–110%.
High precision and reproducibility, demonstrating CV ≤5% with consistent performance across runs, operators, and testing sites.
Internal Control incorporated in every reaction to verify nucleic acid extraction quality and PCR amplification efficiency.
Positive and No Template Controls included to validate assay integrity, monitor contamination, and ensure reliable results.
Validated sample types: Human swab, urine, and blood specimens.
Compatible with leading Real-Time PCR platforms, including Genes2Me RapiCycler 96, Rapi-Q, Bio-Rad CFX96, Thermo Fisher QuantStudio™ 5, and Roche LightCycler® 480, enabling seamless integration into existing laboratory workflows.
No observed cross-reactivity with tested non-target microorganisms, supporting highly specific pathogen identification.

Commercial Name	Old Cat No.	New Cat No.	Pack Size
STI-Q Real-Time PCR Kit	G610026	G610026-4	50 Tests

Since its inception in 2016, Genes2me has been constantly striving towards setting a benchmark in the diagnostics space by introducing premium quality (Made in India) diagnostic kits which are CE-IVD, ISO-13485:2016, and ISO 9001:2015 certified, assuring our clients of unparalleled quality and compliance with international standards.

Product Overview

How the Assay Works

Why Molecular Testing Matters for STI Detection

Sample Type & Reporting Output