Description
PURPOSE
NOVAprep miR-CERVIX reagent kits are designed for the detection of precancerous conditions and cervical cancer by assessing the expression levels of specific microRNAs in biological material. They are intended for the differential diagnosis of mild and severe cervical epithelial dysplasia (LSIL vs. HSIL), including early stages of cervical cancer (carcinoma in situ, CIS).
The NOVAprep miR-CERVIX kits enable the identification of specific microRNA profile alterations in transformed cells, reflecting disease progression. These changes can be diagnostic and prognostic value and can be used to evaluate the effectiveness of ongoing therapy. MicroRNA expression analysis using the NOVAprep miR-CERVIX kit complements traditional diagnostic methods, including conventional and liquid-based cytology and HPV testing. The composition of the kit are reagent kit for material collection, reagent kit for nucleic acid isolation and all reagents required for RT-PCR and PCR.
ASSAY PRINCIPLE
The principle of NOVAprep miR-CERVIX reagent kit is based on the extraction of microRNA from cytological biological material, followed by reverse transcription and real-time quantitative polymerase chain reaction (RT-qPCR). Based on the obtained data, the expression activity of six marker microRNA molecules is quantified. The results are then used to assess the condition of the cervical epithelium and differentiate borderline states (LSIL, HSIL, carcinoma in situ).
CHARACTERISTICS
- comprehensive solution covering the entire workflow from biological sample collection to result interpretation.
- various kit configurations available for different sample volumes – 12, 48, or 96 tests per kit.
- inclusion of endogenous and exogenous internal controls for assay reliability.
- non-invasive testing with the ability to perform the analysis directly in a vial, eliminating the need for repeated sample collection by a gynecologist.
- high result accuracy through software-based data analysis, minimization of the «human factor» in result interpretation.
- high sensitivity and specificity for diagnosing HSIL in patients with ASC-US and LSIL.
- seamless integration into PCR laboratories of various profiles without requiring additional equipment.
- compatibility with biological material obtained from Pap tests using the NOVAprep technology.
- certified medical device safety and compliance with European Union quality standards, validated under Directive 98/79/EC of the European Parliament (Declaration of Conformity No. 013/2022).
