Stark Genotyping HPV Molecular Diagnostic Kit
Catalog Number: ST242001
Package Specification: 25 rxns/Kit
Intended use
The Stark Genotyping HPV Molecular Diagnostic Kit (Real-Time PCR) is an in vitro diagnostic (IVD) tool designed for the qualitative detection and genotyping of human papillomavirus (HPV) DNA in cervical or vaginal specimens. The test specifically identifies 14 high-risk HPV genotypes (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) and 2 low-risk types (6 and 11) by targeting multiple gene regions including L1, E1, E2, E6, and E7.
This kit utilizes a three-channel multiplex real-time PCR system (FAM, Yakima Yellow, ROX/Texas Red) for precise genotyping and includes an internal control for DNA quality and PCR inhibition monitoring.
The test is intended for professional use only by trained and validated laboratory personnel. It is used as an aid in the identification of HPV infections, supporting risk stratification, clinical assessment, and patient management strategies in accordance with applicable clinical guidelines.
Proper specimen handling, validated extraction methods, and strict adherence to the provided protocol are critical to ensure accuracy and reliability of results.
Principle
The Stark Genotyping HPV Molecular Diagnostic Kit is a multiplex, real-time PCR-based assay designed for the qualitative detection and genotyping of 14 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) and 2 low-risk types (6 and 11) in cervical or vaginal specimens.
The assay employs type-specific primers and TaqMan® probes targeting conserved regions of the HPV L1, E1, E2, E6, and E7 genes to amplify viral DNA during real-time PCR. Each HPV type is identified based on the accumulation of a fluorescence signal from a specific dye-labeled probe.
The test is configured into three detection channels:
- FAM: for HPV types 45, 51, 35, 39, 31
- Yakima Yellow (HEX equivalent): for HPV types 16, 33, 52, 58, 68, IC
- ROX (Texas Red equivalent): for HPV types 18, 56, 66, 6, 11, 59
During PCR amplification, the probe hybridizes to its complementary target sequence. As Taq DNA polymerase extends the primer, it cleaves the probe via 5′–3′ exonuclease activity, separating the reporter dye from the quencher and generating a measurable fluorescence signal. This fluorescence increases proportionally with the amount of amplified product, allowing real-time monitoring of the amplification process.
An internal control is included in each reaction to assess sample quality and detect the presence of PCR inhibitors. Amplification curves are analyzed via CT (cycle threshold) values to determine the presence or absence of each target.
The multiplex format allows the simultaneous detection of multiple genotypes in a single reaction, enabling comprehensive HPV profiling for patient risk assessment and clinical management.
Storage
The Stark Genotyping HPV Molecular Diagnostic Kit should be stored at −30 °C to −15 °C. Under proper storage conditions, the reagents are stable until the expiration date printed on the packaging.