產品篩選條件: Infectious Diseases

GB SARS-CoV-2 Ab

PRODUCT DESCRIPTION

This product is a semi-quantitative ELISA reagent designed for detection of IgG and IgM antibodies to SARS-CoV-2 Spike or N protein in human serum or plasma. It uses a direct sandwich ELISA format on a 96-well plate. The test requires only 10 µL of sample and has a 105-minute incubation time with a 450 nm readout. Clinical validation shows 100% sensitivity and 100% specificity. Non-Reactive results indicate no detectable anti-SARS-CoV-2 antibodies; Reactive results signify presence of antibodies, to be interpreted alongside vaccination or infection history.

SPECIFICATION

Number of wells96
PrincipleDirect Sandwich
Assay formatSemi-Quantitative
Total incubation time105 minutes
Sample typeSerum or Plasma
Sample volume10 μL
Reading wavelength450nm
Storage2-8°C
CertificationRUO

PERFORMANCE

5 serum samples collected from RT-PCR confirmed COVID-19 patients were tested. 139 normal healthy patients with samples collected before COVID-19 outbreak were tested. The results are as follows：

The diagnostic sensitivity is 100%；The diagnostic specificity is 100%

Inter-assay precision CV< 10%Inter-assay precision CV< 20%

COMPARISON

Negative (n=89)Positive (n=5)
Company ACompany A
PosNegtotalPosNegtotal
GBCPos000415
Neg28789000
total28789415
SensitivityGBC100%
Company A80%
SpecificityGBC100%
Company A97.7%

ORDERING INFORMATION

Catalogue No.Product
4ECO001GB SARS-COV-2 Ab ELISA – 96T
4ECO002GB SARS-COV-2 Ab ELISA – 480T

GB SARS CoV-2 IgG

PRODUCT DESCRIPTION

This in vitro diagnostic ELISA assay is designed for qualitative detection of IgG antibodies specific for the SARS-CoV-2 spike protein in human serum. It uses an indirect ELISA format on a 96-well microplate, requiring 10 µL of sample, with a total incubation time of 105 minutes and a 450 nm read wavelength. Storage at 2-8°C. Negative (Non-Reactive) results indicate no detectable IgG; positive (Reactive) results suggest presence of spike-protein IgG antibodies, to be interpreted alongside vaccine or infection history. 

SPECIFICATION

Number of wells96
PrincipleIndirect
Assay formatQualitative
Total incubation time105 minutes
Sample typeSerum
Sample volume10 μL
Reading wavelength450nm
Storage2-8°C
CertificationRUO

PERFORMANCE

58 normal healthy patients with samples collected before COVID-19 outbreak were tested. The results are as follows：

The diagnostic sensitivity is 100%；The diagnostic specificity is 96.55%

PERFORMANCETest PositiveTest Negative
Confirmed Positive058
Confirmed Negative256

ORDERING INFORMATION

Catalogue No.Product
4ECO101EGB SARS-CoV-2 IgG – 96T

HIVASE 1+2 (Anti-HIV 1+2)

PRODUCT DESCRIPTION

This in vitro diagnostic ELISA assay is designed for qualitative detection of antibodies to HIV-1 and/or HIV-2 in human serum or plasma. The test uses a direct sandwich ELISA format with a 96-well microplate, a specimen volume of 50 µL, and an incubation time of 90 minutes, read at 450 nm. Certified by TFDA (Taiwan), it provides reliable HIV antibody screening. A Non-Reactive result indicates no detectable HIV-1/2 antibodies; Reactive indicates presence of antibodies and should be interpreted with clinical correlation.

SPECIFICATION

Number of wells96
PrincipleDirect Sandwich
Assay formatQualitative
Total incubation time90 minutes
Sample typeSerum / Plasma
Sample volume50 μL
Reading wavelength450nm
Storage2-8°C
CertificationTFDA

ORDERING INFORMATION

Catalogue No.Product
4HIV3GB HIVASE 1+2 (HIV 1+2)-96 – 96T
4HIV11GB HIVASE 1+2 (HIV 1+2)-480 – 480T

GB COVID-19 Ag Rapid Test (Self-testing)

FEATURE

SPECIFICATION

Number of tests1/5/20
PrincipleLateral Flow Chromatographic Immunoassay
Assay formatQualitative
Time to Results15
Sample typeNasal Swab Specimen
StorageRoom Temperature
CertificationTFDA / CE

PERFORMANCE

The clinical performance of the GB COVID-19 Ag POCT was established with individual symptomatic patients who were suspected of COVID-19. The results are as follows：

Positive percent agreement (PPA): 96.72% (95% CI: 88.65% – 99.60%)Negative percent agreement (NPA): 97.33% (95% CI: 90.70% – 99.68%)Accuracy: 97.06% (95% CI: 92.64% – 99.19%)

PositiveNegative
Positive592
Negative273
Total6175

ORDERING INFORMATION

Catalogue No.Product
4LCO019CGB COVID-19 Ag Rapid Test – 20T
4LCO01ECGB COVID-19 Ag Rapid Test – 5T
4LCO01AEGB COVID-19 Ag Rapid Test – 1T

GB COVID-19 Ag POCT (Professional)

PRODUCT DESCRIPTION

The GB COVID-19 Ag POCT is a qualitative membrane-based lateral flow immunoassay technology based on the double antibody-sandwich method. Using this test allows for the rapid detection of nucleocapsid protein from the SARS-CoV-2 swab from patients who are suspected of COVID-19.

FEATURE

SPECIFICATION

Number of tests20
PrincipleLateral Flow Chromatographic Immunoassay
Assay formatQualitative
Time to Results15
Sample typeNasopharyngeal Swab Specimen
StorageRoom Temperature
CertificationTFDA / CE

PERFORMANCE

The clinical performance of the GB COVID-19 Ag POCT was established with individual symptomatic patients who were suspected of COVID-19. The results are as follows：

Positive percent agreement (PPA): 94.05% (95% CI: 86.65% – 98.04%)Negative percent agreement (NPA): 98.14% (95% CI: 96.00% – 99.32%)Accuracy: 97.30% (95% CI: 95.22% – 98.64%)

PositiveNegative
Positive796
Negative5317
Total84323

ORDERING INFORMATION

Catalogue No.Product
4LCO009EGB COVID-19 Ag POCT – 20T

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.

<br>

<br>

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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<br>

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 HIV Ag-Ab COMB

Product Information Download

Download GBC HIV Ag-Ab COMB (English Version)Download

PRODUCT DESCRIPTION

This product is based on the ELISA sandwich principle, utilizing highly specific antigen–antibody combinations to simultaneously detect HIV-1/2 antibodies and the HIV-1 p24 antigen. In the 96-well microplate, antibodies and antigens are immobilized as the solid phase, while purified peroxidase-conjugated components serve as the detection phase. This design minimizes cross-reactivity and reduces false positives, ensuring high sensitivity and reliability.

GB HIV Ag-Ab COMB assay is a manual 4th generation solid phase Enzyme-Linked Immunosorbent assay using a mixture of antigens and antibodies for the qualitative in vitro diagnostic screening in human serum or plasma (EDTA, Heparin, and Citrate) of antibodies to HIV-1 (group M and O), HIV-2 and HIV-1 p24 antigen. The device is for professional use only.

GB HIV Ag-Ab COMB assay is intended to be used as a screening test for donated blood to prevent transmission of HIV-1/HIV-2 to recipients of blood and blood components.

GB HIV Ag-Ab COMB assay is not intended to screen and diagnose acute or primary HIV infection.

GB HIV Ag-Ab COMB assay result does not distinguish between the detection of HIV-1 antibody, HIV-2 antibody, or HIV-1 p24 antigen and is not for diagnostic use.

PERFORMANCE

The diagnostic sensitivity is 100%；The diagnostic specificity is 99.9%.

PrecisionVariability%CV
Repeatabilitywithin run<20%
Reproducibilitybetween-day<20%
between-run<20%
between-sites<20%
between-operators<20%
between-lots<20%

SPECIFICATION

✱Notified body: 0344

Number of wells96/480
PrincipleSandwich
Assay formatQualitative
Total incubation time150 minutes
Sample typeSerum / Plasma
Sample volume100 μL
Reading wavelength450 nm
Storage2-8°C
CertificationTFDA / CE marked ✱

ORDERING INFORMATION

Catalogue No.Product
4EAIC11GB HIV Ag-Ab COMB – 96T
4EAIC13GB HIV Ag-Ab COMB – 480T