AB ANALITICA Launches REALQUALITY STI-3 and STI-7: The New Generation of Molecular Diagnostics for Sexually Transmitted Infections
One workflow, one platform, a complete IVDR-compliant solution for the diagnosis of sexually transmitted infections (STIs).
With the launch of the new REALQUALITY STI-3 and REALQUALITY STI-7 kits, AB ANALITICA expands its molecular diagnostics portfolio by introducing a highly automated, standardized, and traceable solution for the detection of the most common sexually transmitted infections.
Designed for use on the GENEQUALITY® 2050 platform, the new assays enable laboratories to manage the entire diagnostic process, from nucleic acid extraction and Real-Time PCR amplification to data analysis, through a fully integrated, automated, and IVDR-compliant workflow.
Two Diagnostic Panels for Different Clinical Needs
REALQUALITY STI-3 enables the simultaneous identification of three of the most clinically relevant pathogens associated with sexually transmitted infections:
- Chlamydia trachomatis (CT)
- Neisseria gonorrhoeae (NG)
- Mycoplasma genitalium (MG)
REALQUALITY STI-7 expands the diagnostic panel to include seven targets:
- Chlamydia trachomatis (CT)
- Neisseria gonorrhoeae (NG)
- Mycoplasma genitalium (MG)
- Trichomonas vaginalis (TV)
- Mycoplasma hominis (MH)
- Ureaplasma urealyticum (UU)
- Ureaplasma parvum (UP)
Both kits feature advanced multiplex technology with dual-target amplification, a ready-to-use master mix, a dUTP/UNG contamination prevention system, and an internal control based on the β-globin gene. Positive and negative controls are included in the kit.
Maximum Sample Flexibility
The new assays have been validated in accordance with the European IVDR Regulation for a wide range of clinical specimen types, providing laboratories with greater operational flexibility. Supported sample types include:
- Urine
- Cervical-vaginal swabs
- Urethral swabs
as well as:
- Rectal swabs
- Oropharyngeal swabs
- Seminal fluid
This versatility enables laboratories to effectively address different diagnostic needs and clinical pathways related to sexual health.
Automation, Efficiency, and Traceability
Integrated into the GENEQUALITY® 2050 platform, REALQUALITY STI-3 and STI-7 provide a fully automated diagnostic workflow, including loading verification through a dedicated vision system and the ability to process up to 32 STI-3 samples or 16 STI-7 samples per analytical run.
The total turnaround time from sample to result is approximately 150 minutes for 16 samples and 165 minutes for 32 samples, ensuring high throughput without compromising the quality and reliability of results.
A New Solution for More Comprehensive STI Diagnostics
With REALQUALITY STI-3 and STI-7, AB ANALITICA reaffirms its commitment to developing innovative molecular diagnostic solutions, providing clinical laboratories with a single platform for accurate, efficient, and fully compliant STI testing that meets the latest European regulatory requirements.