Respiratory Test Kit SCoV-2 Ag Detect SCoV-2 Ag Detect Rapid Self-Test 2 Tests

Respiratory Test Kit SCoV-2 Ag Detect SCoV-2 Ag Detect Rapid Self-Test 2 Tests
Key Features
  • SKU: AMS-CAGS-2

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Description

  • SCoV-2 Ag Detect Rapid Self-Test is for use under an FDA Emergency Use Authorization:
  • The SCoV-2 Ag Detect Rapid Self-Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus
  • This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older
  • This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between test
  • Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status
  • Individuals who test positive with the SCoV-2 Ag Detect Rapid Self-Test should self-isolate and seek follow up care with their physician or healthcare provider as additional testing may be necessary
  • All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed
  • Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks

Product Specs

Item Number 1280077
Catalog Number CAGS-2
UOM KT
Level 1 Family Description Lab-Waived Lab
Level 2 Category Description Lab-Respiratory Testing
Level 3 Group Description COVID Testing
Level 4 Sub-Category Description COVID - Rapids
Application Respiratory Test Kit
Brand SCoV-2 Ag Detect
Buy American Act (BAA) Compliant No
Contents 1 (2) Single-Use Tests in Pouch, (2) Single-Use Dropper Bottles, (2) Single Use Test Swabs, Instructions
Country of Origin Unknown
FSA Eligible - Buy UOM Yes
HCPCS K1034
Manufacturer InBios International Inc
Manufacturer # CAGS-2
McKesson # 1280077
Number of Tests 2 Tests
Purchase Program Type Standard Purchase
Reading Type Visual Read
Sample Type Anterior Nasal Swab Sample
Specialty Immunoassay
Test Format Test Device Format
Test Kit Type Rapid
Test Method Lateral Flow
Test Name SCoV-2 Ag Detect Rapid Self-Test
Time to Results 20 Minute Results
Trade Agreement Act (TAA) Compliant No
UNSPSC Code 41116144

Frequently asked questions

How quickly can I see the test results?

The SCoV-2 Ag Detect Rapid Self-Test is designed for efficiency, providing clear results in just 20 minutes.

Can this test be used for young children?

Yes, this test is versatile for different age groups:

  • Self-collection: Suitable for individuals aged 14 and older.
  • Assisted collection: Adults can collect samples from children as young as 2 years old.
Is there a specific testing schedule for symptomatic individuals?

Yes, for symptomatic individuals within the first 5 days of symptom onset, the protocol requires a minimum of two tests over a three-day period, with at least 48 hours between each test.

How should asymptomatic individuals approach testing?

For those who are asymptomatic but suspect COVID-19 exposure, the recommended protocol is to perform three tests over a five-day period, ensuring there are 48 hours between each test.

Is this test kit eligible for FSA reimbursement?

Yes, the SCoV-2 Ag Detect Rapid Self-Test is FSA eligible, making it a convenient option for your health-related expenses.

What items are included in the kit?

Each 2-test kit includes everything you need to perform the tests:

  • (2) Single-Use Test Devices
  • (2) Single-Use Dropper Bottles
  • (2) Single-Use Test Swabs
  • Detailed instructions
Are these tests authorized for home use?

Yes, this kit is specifically designed for non-prescription, home-based use and is authorized under an FDA Emergency Use Authorization (EUA).

How do I collect the sample for this test?

The test uses a simple anterior nasal (nares) swab method, which is designed to be user-friendly for home testing.

Do negative results confirm I don't have COVID-19?

Negative results are considered presumptive. They should not be used as the sole basis for clinical or infection control decisions; always correlate results with clinical observations and public health guidance.

Is this test reliable for screening programs?

Yes, the kit is an excellent tool for households, travel preparation, or workplace screening programs to support ongoing health monitoring, provided it is used in conjunction with official public health guidance.