«NOVAprep® miR-Cervix» Reagent kit

Precancerous conditions and cervical cancer detection by RT-PCR in biological material by means miRNA profiling.

Designed for differential diagnosis of cervical precancer and cancer by determining the expression levels of specific microRNAs in biological material using reverse transcription PCR (RT-PCR).

Automated or manual microRNA extraction.
Capability for parallel cytological examination, HPV testing, and microRNA analysis in cytological samples.
Differential diagnosis of mild and severe cervical epithelial dysplasia (LSIL vs. HSIL), including early stages of cervical cancer (CIS).
High result accuracy ensured by software-based data analysis.
Declaration of conformity № 013/2022.

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).

Release form

Cat. Number	Product name	Note
CЕRVIX-12	NOVAprep miR-CЕRVIX, Release form 1	Complete reagent kit for biological sample collection, manual microRNA extraction, RT-PCR, and PCR for 12 samples
CЕRVIX-48М	NOVAprep miR-CЕRVIX, Release form 2	Complete reagent kit for biological sample collection, manual microRNA extraction, RT-PCR, and PCR for 48 samples
CЕRVIX-48А	NOVAprep miR-CЕRVIX, Release form 3	Complete reagent kit for biological sample collection, automated microRNA extraction, RT-PCR, and PCR for 48 samples
CЕRVIX-96М	NOVAprep miR-CЕRVIX, Release form 4	Complete reagent kit for biological sample collection, manual microRNA extraction, RT-PCR, and PCR for 96 samples
CЕRVIX-96А	NOVAprep miR-CЕRVIX, Release form 5	Complete reagent kit for biological sample collection, automated microRNA extraction, RT-PCR, and PCR for 96 samples
CЕRVIX-EXT-1	NOVAprep miR-CЕRVIX, EXT-1	Reagent kit for biological sample collection and manual microRNA extraction for 12 samples
CЕRVIX-EXT-2	NOVAprep miR-CЕRVIX, EXT-2	Reagent kit for biological sample collection and manual microRNA extraction for 48 samples
CЕRVIX-EXT-3	NOVAprep miR-CЕRVIX, EXT-3	Reagent kit for biological sample collection and automated microRNA extraction for 48 samples
CЕRVIX-EXT-4	NOVAprep miR-CЕRVIX, EXT-4	Reagent kit for biological sample collection and manual microRNA extraction for 96 samples
CЕRVIX-EXT-5	NOVAprep miR-CЕRVIX, EXT-5	Reagent kit for biological sample collection and automated microRNA extraction for 96 samples
CЕRVIX- PCR-1	NOVAprep miR-CЕRVIX, PCR-1	96-well plates for RT-PCR and PCR for 12 samples
CЕRVIX-PCR-2	NOVAprep miR-CЕRVIX, PCR-2	96-well plates for RT-PCR and PCR for 48 samples
CЕRVIX-PCR-3	NOVAprep miR-CЕRVIX, PCR-3	96-well plates for RT-PCR and PCR for 96 samples

Documentation

Brochure.pdf

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«NOVAprep® miR-Cervix» Reagent kit