產品系列 / 解決方案: COVID-19 Solution

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

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

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
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