產品系列 / 解決方案: Molecular Diagnostic Solutions

HBV RealQuant™ PCR

PRODUCT DESCRIPTION

The GB HBV RealQuant™ PCR kit is an in-vitro quantitative PCR assay for HBV DNA viral load in human serum or plasma. Purpose-built primers/probes cover genotypes A–E and G, including wild-type and mutant variants, supporting reliable detection across diverse patient populations. An Internal Control (IC) travels with each sample through extraction and amplification to verify nucleic-acid recovery and identify PCR inhibition, enhancing run-to-run reliability.

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The assay achieves a limit of detection of 16 IU/mL and is validated on commonly used qPCR instruments—Applied Biosystems QuantStudio™ 5, Bio-Rad CFX96, Qiagen Rotor-Gene Q MDx—as well as the GBC AIO M160 automation platform for streamlined workflows. These features enable precise baseline

FEATURE

SPECIFICATION

✱Notified body: 0344

Number of tests48
GenotypeA-E, G, wild types and mutants
Internal ControlPseudoviruses
Extraction Platform (compatible)Magnetic beads / Column technology
Sample typeSerum / Plasma
PCR Instrument (compatible)GBC AIO System, ABI 7500, Qiagen, Thermo, BioRad
LoD16 IU/ml
CertificationTFDA / CE marked ✱

ORDERING INFORMATION

Catalogue No.Product
4HBPA2HBV RealQuant™ PCR – 48T

HCV RealQuant™ PCR

PRODUCT DESCRIPTION

The GB HCV RealQuant™ PCR kit is an in vitro diagnostic RT-PCR assay designed for the quantitative detection of hepatitis C virus (HCV) RNA, covering genotypes 1–6, from human serum or plasma. With a limit of detection of approximately 37.28 IU/mL, and an internal control (IC) that spans extraction and amplification phases, the assay ensures reliability and sensitivity. It is validated for use on open platforms such as GB AIO System, Applied Biosystems QuantStudio 5, Bio-Rad CFX96, Qiagen Rotor-Gene Q MDx, among others. Ideal for labs seeking accurate HCV viral load monitoring, treatment response tracking, and standardized workflow without vendor dependency.

FEATURES

SPECIFICATION

Number of tests48
GenotypeHCV 1-6 genotype
Internal ControlIC RNA
Extraction Platform (compatible)Magnetic beads / Column technology
Sample typeSerum / Plasma
PCR Instrument (compatible)GBC AIO System, ABI 7500, Qiagen, Thermo, BioRad
LoD37.28 IU/ml
CertificationTFDA

ORDERING INFORMATION

Catalogue No.Product
4HCPA2GB HCV RealQuant™ RT-PCR – 48T

GB SARS-CoV-2 Real-Time RT-PCR Multiplex Kit (E / N / ORF1ab)

PRODUCT DESCRIPTION

The GB SARS-CoV-2 Real-Time RT-PCR Multiplex Kit (E/N/ORF1ab) is an in vitro diagnostic nucleic acid amplification reagent designed for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal swab specimens.

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Primers and probes simultaneously target the E gene, N gene, and ORF1ab gene of SARS-CoV-2, while an integrated RNase P extraction control (EC) monitors nucleic acid recovery and amplification integrity throughout the workflow. This ensures reliable results and minimizes false negatives caused by extraction or inhibition issues.

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The assay achieves a limit of detection (LoD) of approximately 1000 copies/mL, with sample processing time suitable for <br>

<br>high-throughput laboratory workflows. Reagents should be stored at 2–8°C, protected from light, and must not be frozen.

The kit is validated across multiple PCR platforms, including the GB AIO System, Applied Biosystems QuantStudio™ 5, Bio-Rad CFX96, Qiagen Rotor-Gene Q MDx, and Roche PCR instruments, giving laboratories platform flexibility without vendor lock-in.

FEATURE

SPECIFICATION

Number of tests100
TargetsE gene, N gene, ORF1ab (RdRp) and RNaseP (Extraction control, EC)
Extraction ControlRNase P
Extraction Platform (compatible)Magnetic beads / Column technology
Sample typeRespiratory specimens (i.e., nasopharyngeal/oropharyngeal swabs, nasal swabs and mid-turbinate swabs specimens)
PCR Instrument (compatible)GBC AIO System, Qiagen, Roche, Thermo, BioRad
Sensitivity (LoD)1000 copies/mL
CertificationRUO

ORDERING INFORMATION

Catalogue No.Product
4PCO112EGB SARS-CoV-2 Real-Time RT-PCR Multiplex – 100T

GB SARS-CoV-2 Influenza A/B Multiplex PCR (Flu A/B, N)

PRODUCT DESCRIPTION

The GB SARS-CoV-2 Influenza A/B Multiplex PCR Kit is an in vitro diagnostic real-time RT-PCR assay designed for simultaneous qualitative detection of SARS-CoV-2 (N gene), Influenza A (M1 gene), and Influenza B (NS1 gene) in respiratory tract specimens (nasopharyngeal/oropharyngeal swabs, nasal swabs, mid-turbinate swabs).

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It includes RNase P as an extraction control to monitor sample quality and detect extraction or amplification failures. The limits of detection are approximately 1000 copies/mL for SARS-CoV-2, 500 copies/mL for Influenza A, and 250 copies/mL for Influenza B. Reagent is CE certified and validated across major platforms including GB AIO System, QuantStudio™ 5, Bio-Rad CFX96, and QIAGEN RGQ Real-Time PCR Systems. Ideal for differentiating multiple respiratory pathogens during flu season and improving diagnostic throughput.

FEATURE

SPECIFICATION

Number of tests100
TargetsSARS-CoV-2 (N gene) / Influenza A (M1) / Influenza B (NS1)
Extraction ControlRNase P
Extraction Platform (compatible)Magnetic beads / Column technology
Sample typeRespiratory specimens (i.e., nasopharyngeal/oropharyngeal swabs, nasal swabs and mid-turbinate swabs specimens)
PCR Instrument (compatible)GBC AIO System, Qiagen, Roche, Thermo, BioRad
Sensitivity (LoD)influenza A virus: 500 copies/mLinfluenza B virus: 250 copies/mLSARS-CoV-2 virus:  1000 copies/mL
CertificationRUO

ORDERING INFORMATION

Catalogue No.Product
4PCO102EGB SARS-CoV-2 Influenza A/B Multiplex – 100T

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
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