HPV 13 High-risk Subtypes DNA Diagnostic Kit (CE marked)
Description
13 Types of High-Risk Human Papillomavirus Nucleic Acid Detection Kit (PCR-Fluorescent Probe) is applicable to the in vitro qualitative detection of 13 human papillomavirus (HPV) subtypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) in exfoliated cell of uterine whisker and wart cell samples from urethral discharge. The kit could be used for the auxiliary diagnosis of HPV infection and provide reference for related conditions, prognosis, and treatment. The product is for professional use only. Not for self-testing.
The kit designs specific primers and probes for HPV genome L1 region, and adopts real-time fluorescent PCR technology to detect 13 common high-risk HPV genotypes,
The designed primers can cover the above 13 subtypes’ detection, and the positive results only indicate single-type or mixed-type infection of the 13 subtypes.
Clinical Significances
New era of cervical cancer screening
Preferred alternative of ASCUS
HPV vaccines investigation
Follow-up on cervical lesions and prognosis treatment
Advantages and Features
1. Sensitivity: 1 × 103 copies/mL for the HPV 13 subtypes.
2. Specificity: The kit has no cross reaction with the urogenital tract pathogens including treponema pallidum (TP), mycoplasma hominis (MH), Neisseria gonorrhoeae (NG), chlamydia trachomatis (CT), ureaplasma urealyticum (UU), and other HPV subtypes (including common subtypes such as HPV 6, 11, 42, 43, and 44 positive samples).
3. Precision: The Ct value’s coefficient of variation (CV) of the kit’s detection results on HPV 13 subtypes is less than 10%.
4. Suitable for general-purpose fluorescent PCR equipment.
5. Time: less than 1.5 hours
Qualification: CE marked；ISO 13485
Specimens
Urethral secretions, cervical exfoliated cells or verruca cells etc.
Storage
The kit should be stored at −20 ± 5 °C away from light, avoiding repeated freezing and thawing. Refer to the label for manufacture date and expiration date.
Thawing stability after opening: The kit is still valid for use after opening for 8 hours. Avoid long-time opening in case of evaporation.
Packing Specification:
20 tests/kit
