7235352
Chembio SCoV-2 Ag Detect™ Rapid Test Kit
The SCoV-2 Ag Detect Rapid Test Kit can be used for testing symptomatic or asymptomatic patients using a direct nasal sample that gives results in about 20 minutes.
Manufacturer: Fischer Scientific
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Content And Storage
15°C to 30°C
Clia Complexity
Waived
Sample Type
Direct Nasal Swab
Type
SARS-CoV-2 Rapid Antigen Test
For Use With (Application)
Intended for the qualitative detection of SARS-CoV-2 Nucleoprotein antigen in direct anterior nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.
Species
Human
Test Time
20 Min.
CE Marker
Yes
Detectable Analytes
SARS-CoV-2 Antigens
Sensitivity
0.8667
Disposable
Single-use
Includes
Pouched cassettes, 1 positive control, 1 negative control, sterile swabs, lysis buffer
Specificity
1
Form
Liquid
Related Products
Description
- Description SCoV-2 Ag Detect™ Rapid Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 Nucleoprotein antigen in direct anterior nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests
- Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C
- §263a, that meet the requirements to perform moderate, high or waived complexity tests
- This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
- Easy to use POC SARS-CoV-2 Nucleoprotein antigen test that can performed in many settings with symptomatic or asymptomatic patients Identifies acute infection in symptomatic patients with high accuracy: PPA (Sensitivity) 86.67%, NPA (Specificity) 100% Direct nasal sample Results in approximately 20 minutes No instrumentation needed
SAFETY INFORMATION
- ShelfLife : 6 Months
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Content And Storage: 15°C to 30°C
Clia Complexity: Waived
Sample Type: Direct Nasal Swab
Type: SARS-CoV-2 Rapid Antigen Test
For Use With (Application): Intended for the qualitative detection of SARS-CoV-2 Nucleoprotein antigen in direct anterior nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.
Species: Human
Test Time: 20 Min.
CE Marker: Yes
Detectable Analytes: SARS-CoV-2 Antigens
Sensitivity: 0.8667
Disposable: Single-use
Includes: Pouched cassettes, 1 positive control, 1 negative control, sterile swabs, lysis buffer
Specificity: 1
Form: Liquid
Content And Storage:
15°C to 30°C
Clia Complexity:
Waived
Sample Type:
Direct Nasal Swab
Type:
SARS-CoV-2 Rapid Antigen Test
For Use With (Application):
Intended for the qualitative detection of SARS-CoV-2 Nucleoprotein antigen in direct anterior nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.
Species:
Human
Test Time:
20 Min.
CE Marker:
Yes
Detectable Analytes:
SARS-CoV-2 Antigens
Sensitivity:
0.8667
Disposable:
Single-use
Includes:
Pouched cassettes, 1 positive control, 1 negative control, sterile swabs, lysis buffer
Specificity:
1
Form:
Liquid
Content And Storage: Store at 4°C for up to 3 months. For longer storage, aliquot and store at -20°C.
Clia Complexity: __
Sample Type: __
Type: __
For Use With (Application): __
Species: __
Test Time: __
CE Marker: __
Detectable Analytes: __
Sensitivity: __
Disposable: __
Includes: __
Specificity: __
Form: Purified
Content And Storage:
Store at 4°C for up to 3 months. For longer storage, aliquot and store at -20°C.
Clia Complexity:
__
Sample Type:
__
Type:
__
For Use With (Application):
__
Species:
__
Test Time:
__
CE Marker:
__
Detectable Analytes:
__
Sensitivity:
__
Disposable:
__
Includes:
__
Specificity:
__
Form:
Purified
Content And Storage: Use a manual defrost freezer and avoid repeated freeze-thaw cycles.12 months from date of receipt, -20 to -70 °C as supplied. 1 month, 2 to 8 °C under sterile conditions after reconstitution. 6 months, -20 to -70 °C under sterile conditions after reconstitution.
Clia Complexity: __
Sample Type: __
Type: __
For Use With (Application): __
Species: __
Test Time: __
CE Marker: __
Detectable Analytes: __
Sensitivity: __
Disposable: __
Includes: __
Specificity: __
Form: Purified
Content And Storage:
Use a manual defrost freezer and avoid repeated freeze-thaw cycles.12 months from date of receipt, -20 to -70 °C as supplied. 1 month, 2 to 8 °C under sterile conditions after reconstitution. 6 months, -20 to -70 °C under sterile conditions after reconstitution.
Clia Complexity:
__
Sample Type:
__
Type:
__
For Use With (Application):
__
Species:
__
Test Time:
__
CE Marker:
__
Detectable Analytes:
__
Sensitivity:
__
Disposable:
__
Includes:
__
Specificity:
__
Form:
Purified
Content And Storage: Use a manual defrost freezer and avoid repeated freeze-thaw cycles.12 months from date of receipt, -20 to -70 °C as supplied. 1 month, 2 to 8 °C under sterile conditions after reconstitution. 6 months, -20 to -70 °C under sterile conditions after reconstitution.
Clia Complexity: __
Sample Type: __
Type: __
For Use With (Application): __
Species: __
Test Time: __
CE Marker: __
Detectable Analytes: __
Sensitivity: __
Disposable: __
Includes: __
Specificity: __
Form: Purified
Content And Storage:
Use a manual defrost freezer and avoid repeated freeze-thaw cycles.12 months from date of receipt, -20 to -70 °C as supplied. 1 month, 2 to 8 °C under sterile conditions after reconstitution. 6 months, -20 to -70 °C under sterile conditions after reconstitution.
Clia Complexity:
__
Sample Type:
__
Type:
__
For Use With (Application):
__
Species:
__
Test Time:
__
CE Marker:
__
Detectable Analytes:
__
Sensitivity:
__
Disposable:
__
Includes:
__
Specificity:
__
Form:
Purified