GB HPV Genotypes Real Time PCR

PRODUCT DESCRIPTION

The GB HPV Genotypes Real-Time PCR Kit is an in vitro molecular diagnostic reagent designed for the qualitative detection and genotyping of human papillomavirus (HPV). Utilizing multiplex real-time PCR technology, the assay simultaneously identifies both low-risk HPV types (6, 11, 44) and high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, 73) directly from urogenital swabs and biopsy specimens.

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By providing accurate differentiation between low- and high-risk HPV genotypes, the assay offers valuable information for cervical cancer risk stratification, screening programs, and epidemiological studies. An internal control is included in each reaction to monitor sample quality and ensure result reliability.

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This kit is intended to support HPV surveillance, research, and preventive healthcare strategies, particularly in assessing the correlation between high-risk HPV infection and cervical intraepithelial neoplasia or cervical cancer progression.

FEATURE

●Internal Control (IC): Monitors extraction, amplification, and inhibition.

●Genotype-level reporting: LR (6/11/44) + HR (16/18/31/33/35/39/45/51/52/56/58/59/66/68/73).

●Open-platform workflow: Validated on QuantStudio™ 5, CFX96, Rotor-Gene Q MDx.

SPECIFICATION

GenotypeLow-risk HPV types (HPV 6, 11, 44)High-risk HPV types (HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, 73)
Internal ControlHuman β globin gene
Extraction Platform (compatible)Magnetic beads / Column technology
Sample typeUrogenital swabs / Biopsies specimens
PCR Instrument (compatible)Thermo Fisher Scientific、BioRad、Qiagen
CertificationRUO

ORDERING INFORMATION

Catalogue No.Product
4PPP011RGB HPV Genotypes Real-Time PCR

GB CL SCC

PRODUCT DESCRIPTION

This in vitro diagnostic quantitative CL reagent uses the sandwich chemiluminescent immunoassay format to measure squamous cell carcinoma antigen (SCCA) in human serum or plasma. It requires 20 µL specimen and provides results in about 10 minutes. LoQ is 0.28 ng/mL. Stored at 2-8°C, avoid direct sunlight and freezing. TFDA certified. Useful for detection and monitoring of squamous cell carcinomas, including cervical and head & neck cancer types.

PERFORMANCE

Limit of Quantitation (LoQ): 0.28 ng/mL
PrecisionVariabilityCoefficient of variation, CV (%)
Repeatabilitywithin run<10%
Reproducibilitybetween-run/between-day<10%
between-sites/between-operators<10%
between-lots<10%

SPECIFICATION

PrincipleSandwich-type chemiluminescent immunoassay
Assay formatQuantification
Rreaction time10 minutes
Sample typeSerum/Plasma
Sample volume20 μL
Detection unitRelative light unit (RLU)
Storage2-8°C. Avoid exposure to direct sunlight. Do not freeze.
CertificationTFDA

ORDERING INFORMATION

Catalogue No.Product
4ASCC02GB CL SCC
4ASCC1BGB CL SCC-Control
4ASCC2BGB CL SCC-Calibrator

GB CL CA125

PRODUCT DESCRIPTION

This reagent is an in vitro quantitative assay using a sandwich chemiluminescent microparticle immunoassay format to measure CA-125 in human serum or plasma. It requires 10 µL sample and delivers results in approximately 10 minutes. The limit of quantification (LoQ) is 1.50 U/mL. Stored at 2-8°C, avoid direct sunlight and do not freeze. Used clinically as a tumor marker particularly for ovarian cancer diagnosis and monitoring.

PERFORMANCE

Limit of Quantitation (LoQ): 1.50 U/mL
PrecisionVariabilityCoefficient of variation, CV (%)
Repeatabilitywithin run<10%
Reproducibilitybetween-run/between-day<10%
between-sites/between-operators<10%
between-lots<10%

SPECIFICATION

PrincipleSandwich-type chemiluminescent immunoassay
Assay formatQuantification
Rreaction time10 minutes
Sample typeSerum/Plasma
Sample volume10 μL
Detection unitRelative light unit (RLU)
Storage2-8°C. Avoid exposure to direct sunlight. Do not freeze.
CertificationRUO

ORDERING INFORMATION

Catalogue No.Product
4ACA502GB CL CA125
4ACA51BGB CL CA125-Control
4ACA52BGB CL CA125-Calibrator