COVID-19
The COVID-19 Tests are in vitro immunochromatographic assay for the rapid, qualitative detection of nucleocapsid protein antigen, IgG/IgM antibodies, neutralizing antibody from SARS-CoV-2 in human Whole blood, serum, plasma, nasopharyngeal swab, nasal swab and oral fluid specimens.
Features:
- Qualitative, visually read results in 10 to 15 minutes
- Detect COVID-19 Infection with a simple and rapid procedure
- Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)
- All necessary reagents provided & no equipment needed
- High sensitivity and specificity
Specifications:
Clinical Evaluation: Sensitivity 97.25% / Specificity >99% / Accuracy 98.73%
- Specimen: Nasal swab, Nasopharyngeal swab, Oral Fluid, Whole blood, serum, plasma
- Time to Results: 10 to 15 minutes
- Shelf Life: 24 months from the date of manufacture
Some of the SKUs are available for sale exclusively outside the US. Please contact us for more information.
Ordering Information
| Product Description | Specimen | Catalog No. | Format | Kit Size | Qualification |
|---|---|---|---|---|---|
| COVID-19 Ag Rapid Test Cassette (Swab) | Nasal swab | GCCOV-502a-NA | Cassette | 1/2/3/5/7/10/15/20 Test(s)/Kit | CE marked |
| Coronavirus Ag Rapid Test Cassette (swab) | Nasopharyngeal swab | GCCOV-502a | Cassette | 20 Tests/Kit | CE marked |
| Coronavirus Ag Rapid Test Cassette (swab) | Nasopharyngeal swab | GCCOV-502Ca | Cassette | 20 Test(s)/Kit (with Control) | CE marked |
| Coronavirus Ag Rapid Test Cassette (swab) | NA & NP Swab | GCCOV-502a-NN | Cassette | 20 Tests/Kit | CE marked |
| Rapid COVID-19 Antigen Self-Test | Nasal swab | GCCOV-502a-Hxx | Cassette | 1/2/3/5/7/10/15/20 Test(s)/Kit | CE 0123 |
| Rapid COVID-19 (Antigen) Self-Test | Nasal swab | GCCOV-502a-HxxOGE | Cassette | 1/2/3/5/7/8/10/15/20 Tests/Kit | CE 0123 |
| COVID-19 Ag Rapid Test (Oral Fluid) | Oral Fluid | GCCOV-702a | Cassette | 20 Test(s)/Kit | CE marked |
| Rapid COVID-19 Antigen Oral Fluid Self-Test | Oral Fluid | GCCOV-702a-Hxx | Cassette | 1/2/3/5/7/10/15/20 Test(s)/Kit | CE 0123 |
| Digital COVID-19 Ag Rapid Test | Nasal swab | GCCOV-D503a | / | 1/2/3/5/7/10/15/20 Test(s)/Kit | CE marked |
| Smart Rapid COVID-19 Test Device | Nasal swab | GCCOV-503a | Device | 1/2/5/10 Test(s)/Kit | CE marked |
| COVID-19 IgG/IgM Rapid Test Cassette | Whole blood/Serum/Plasma | GCCOV-402a | Cassette | 25 Tests/Kit | CE marked |
COVID-19/Flu Combo
Some of the SKUs are available for sale exclusively outside the US. Please contact us for more information.
COVID-19/Flu/RSV Combo
Some of the SKUs are available for sale exclusively outside the US. Please contact us for more information.
COVID-19/Flu/RSV/Adeno Combo
Some of the SKUs are available for sale exclusively outside the US. Please contact us for more information.
Influenza (Flu)
The Influenza Antigen Rapid Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A (including the subtype H1N1) and/or B nucleoprotein antigens in nasopharyngeal (NP) swab, nasal swab, and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections.
Features:
- Two band results for simple interpretation
- Detects Influenza A/B antigen
- Room temperature storage or refrigerated (2-30⁰C)
- Easy to read results
Specifications:
- Cut-off:1.5 x 104TCID50/test for the Influenza A virus antigen;1.5 x 105TCID50/test for the Influenza B virus antigen
- Specimen: Nasal swab, Throat swab
- Time to Results: 10 minutes
- Shelf Life: 24 months from the date of manufacture
Some of the SKUs are available for sale exclusively outside the US. Please contact us for more information.
Ordering Information
| Product Description | Specimen | Catalog No. | Format | Cut-off Value | Kit Size | Qualification |
|---|---|---|---|---|---|---|
| Influenza A Ag Rapid Test Strip | Nasal/Throat Swabs | GCFLU(A)-501a | Strip | 1.5×104 TCID50 | 25 Tests/Kit | CE marked |
| Influenza A Ag Rapid Test Cassette | Nasal/Throat Swabs | GCFLU(A)-502a | Cassette | 1.5×104 TCID50 | 20 Tests/Kit | CE marked |
| Influenza A&B Ag Rapid Test Strip | Nasal/Throat Swabs | GCFLU(A/B)-501a | Strip | 1.5×104 TCID50/ 1.5×105 TCID50 | 25 Tests/Kit | CE marked |
| Influenza A&B Ag Rapid Test Cassette | Nasal/Throat Swabs | GCFLU(A/B)-502a | Cassette | 1.5×104 TCID50/ 1.5×105 TCID50 | 20 Tests/Kit | CE marked |
| Influenza A&B Ag Rapid Test Cassette | Nasal/Throat Swabs | GCFLU(A/B)-502Ca | Cassette | 1.5×104 TCID50/ 1.5×105 TCID50 | 20 Tests/Kit | CE marked |
Mononucleosis
The Mononucleosis Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of 4 serologic markers of Epstein-Barr virus (EBV), two of IgM class, VCA and heterophile antibodies, and two of IgG class, VCA and EBNA, in human whole blood, serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infectious mononucleosis. Any reactive specimen with the Mononucleosis Rapid Test must be confirmed with alternative testing method(s) and clinical findings.
Features:
- Two band results for simple interpretation
- Room temperature storage or refrigerated (2-30⁰C)
- Easy to read results
- Internal control included
Specifications:
- For IgM: Sensitivity: 95.2%, Specificity: 98.3%
- For HA: Sensitivity: 96.9%, Specificity: 97.8%
- For EBNA-IgG: Sensitivity: 95.2%, Specificity: 96.3%
- For VCA-IgM: Sensitivity: 95.9%, Specificity: 97.6%
- For VCA-IgG: Sensitivity: 96.6%, Specificity: 97.5%
- Specimen: Whole blood, serum, plasma
- Time to Results: 8 to 15 minutes
- Shelf Life: 24 months from the date of manufacture
Ordering Information
| Product Description | Specimen | Catalog No. | Format | Kit Size | Qualification |
| Mononucleosis IgM Rapid Test | Serum/Plasma | GCMON-325a | Cassette | 25 Tests/Kit | CE marked |
| Mononucleosis IgM Rapid Test | Whole blood/Serum/Plasma | GCMON-402a | Cassette | 25 Tests/Kit | CE marked |
| Mononucleosis IgG/IgM Rapid Test | Whole blood/Serum/Plasma | GCMON-425a | Cassette | 25 Tests/Kit | CE marked |
M. pneumoniae
The M. pneumoniae IgM Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of IgM antibodies to Mycoplasma pneumonia antigen in seru m or plasma to aid in the diagnosis of recent Mycoplasma pneumoniae infection.
Features:
- Detects M. pneumoniae IgM antibody
- Internal control included
- Reagents included
- Room temperature storage or refrigerated (2-30⁰C)
- Easy to read results
Specifications:
- Sensitivity: 96.4%
- Specificity: 96.3%
- Specimen: Serum, Plasma
- Time to Results: 5 minutes
- Shelf Life: 24 months from the date of manufacture
Ordering Information
| Product Description | Specimen | Catalog No. | Format | Kit Size | Qualification |
|---|---|---|---|---|---|
| M. pneumoniae IgM Test | S/P | GCMP(IgM)-302a√ | Cassette | 25 Tests/Kit | CE marked |
RSV
The RSV Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Respiratory Syncytial Virus (RSV) antigen (viral fusion protein) in human nasal/nasopharyngeal swab, nasal/nasopharyngeal aspirate samples. It intended as a screening test and as an aid in the diagnosis of RSV respiratory infections.
Features:
- Two band results for simple interpretation
- Detects Respiratory Syncytial Virus antigen
- Room temperature storage or refrigerated (2-30⁰C)
- Easy to read results
Specifications:
- Sensitivity: >99%
- Specificity: >99%
- Accuracy: >98%
- Specimen: Nasal swab, Nasopharyngeal swab
- Time to Results: 15 minutes
- Shelf Life: 24 months from the date of manufacture
Ordering Information
| Product Description | Specimen | Catalog No. | Format | Kit Size | Qualification |
|---|---|---|---|---|---|
| RSV Antigen Test | Nasal swab/Nasopharyngeal swab | GCRSV-502a | Cassette | 20 Tests/Kit | CE marked |
| Rapid Check RSV Antigen Test | Nasal swab/Nasopharyngeal swab | GCRSV-502Sa | Cassette | 20 Tests/Kit | 510(k) CLIA WAIVED |
Strep A
The Strep A Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection.
Features:
- Two band results for simple interpretation
- Room temperature storage or refrigerated (2-30⁰C)
- Easy to read results
- Internal control included
Specifications:
- Sensitivity: 92.3%
- Specificity: 96.4%
- Specimen: Throat Swab
- Time to Results: 5 minutes
- Shelf Life: 24 months from the date of manufacture
Ordering Information
| Product Description | Specimen | Catalog No. | Format | Kit Size | Qualification |
|---|---|---|---|---|---|
Strep A Rapid Test | Throat swab | GCSTR-501a√ | Strip | 25 Tests/Kit | CE marked |
| Throat swab | GCSTR-501Ca√╅ | Strip | 25 Tests/Kit | CE marked, 510(k) | |
| Throat swab | GCSTR-502a√ | Cassette | 20 Tests/Kit | CE marked | |
| Throat swab | GCSTR-502Ca√ | Cassette | 20 Tests/Kit | CE marked |
Tuberculosis
The Tuberculosis IgG/IgM Rapid Test is a rapid membrane-based screening test for the rapid detection of IgM anti-Mycobacterium Tuberculosis and IgG anti-Mycobacterium Tuberculosis in human in serum, plasma or whole blood.
Features:
- Two band results for simple interpretation
- Detects Tuberculosis antigen
- Room temperature storage or refrigerated (2-30⁰C)
- Easy to read results
Specifications:
- Clinical performance for IgG: Sensitivity: 87.2% / Specificity: 97.3% / Accuracy: 95.6%
- Clinical performance for IgM: Sensitivity: 83.5% / Specificity: 98.1% / Accuracy: 95.1%
- Specimen: Whole blood, Serum, Plasma
- Time to Results: 10 minutes
- Shelf Life: 24 months from the date of manufacture
Ordering Information
| Product Description | Specimen | Catalog No. | Format | Kit Size | Qualification |
|---|---|---|---|---|---|
Tuberculosis IgG/IgM Rapid Test | S/P | GCTB-302a√ | Cassette | 25 Tests/Kit | CE marked |
| WB/S/P | GCTB-402a√ | Cassette | 25 Tests/Kit | CE marked |