23-999-116
Chembio SCoV-2 Ag Detect™ Rapid Test Kit
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.
Quantity
50 Tests/Kit
Specificity
1
Form
Liquid
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
Species
Human
Test Time
20 Min.
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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.
Quantity: 50 Tests/Kit
Specificity: 1
Form: Liquid
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
Species: Human
Test Time: 20 Min.
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.
Quantity:
50 Tests/Kit
Specificity:
1
Form:
Liquid
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
Species:
Human
Test Time:
20 Min.
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.
Quantity: 20 Tests/Kit
Specificity: 1
Form: Liquid
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
Species: Human
Test Time: 20 Min.
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.
Quantity:
20 Tests/Kit
Specificity:
1
Form:
Liquid
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
Species:
Human
Test Time:
20 Min.
Content And Storage: __
Clia Complexity: Waived (FDA, EUA)
Sample Type: Nasal Swab
Type: At-home COVID Test Kit
For Use With (Application): __
Quantity: 2 Tests/Kit
Specificity: __
Form: __
CE Marker: __
Detectable Analytes: SARS-CoV-2
Sensitivity: __
Disposable: __
Includes: __
Species: __
Test Time: 20 mins.
Content And Storage:
__
Clia Complexity:
Waived (FDA, EUA)
Sample Type:
Nasal Swab
Type:
At-home COVID Test Kit
For Use With (Application):
__
Quantity:
2 Tests/Kit
Specificity:
__
Form:
__
CE Marker:
__
Detectable Analytes:
SARS-CoV-2
Sensitivity:
__
Disposable:
__
Includes:
__
Species:
__
Test Time:
20 mins.
Content And Storage: 2°C to 25°C
Clia Complexity: Waived
Sample Type: Fingerstick Whole Blood, Venous Whole Blood, Plasma
Type: Rapid Test
For Use With (Application): DPP Rapid Test
Quantity: 20 Tests/Kit
Specificity: __
Form: __
CE Marker: Yes
Detectable Analytes: HIV, T. pallidum
Sensitivity: __
Disposable: __
Includes: 20 Kits and 1 Reader
Species: __
Test Time: __
Content And Storage:
2°C to 25°C
Clia Complexity:
Waived
Sample Type:
Fingerstick Whole Blood, Venous Whole Blood, Plasma
Type:
Rapid Test
For Use With (Application):
DPP Rapid Test
Quantity:
20 Tests/Kit
Specificity:
__
Form:
__
CE Marker:
Yes
Detectable Analytes:
HIV, T. pallidum
Sensitivity:
__
Disposable:
__
Includes:
20 Kits and 1 Reader
Species:
__
Test Time:
__