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USA Rapid Test Kits

PRODUCT INFORMATION


    One provider, multiple rapid-testing solutions

    Inquire now for FDA/EUA Approved COVID-19 test kits.

    A valid CLIA number is required.

    FDA/EUA Authorized Products

    Antigen test is based on lateral-flow immunochromatographic assay and does not require additional equipment for detection or analyses. The test detects antigens specific to SARS-CoV-2 in nasopharyngeal specimens collected from individuals suspected of being infected with COVID-19 or exposed to COVID-19.

    COVID-19 Antibody Rapid Test is a lateral flow in-vitro immunoassay intended to detect the presence of SARS-CoV-2 IgM and IgG antibodies from a whole blood sample (usually finger prick). These antibodies develop in our body in response to a previous infection by SARS-CoV-2 or in response to vaccination.

    INDICAID
    COVID-19 Antigen Rapid Test

    Indicaid COVID-19 rapid antigen test. Test kit includes items for 25 tests. Convenient, easy to use, get results in 15 minutes.

    Each Kit Contains:

    • 25 Test cassettes
    • 25 Sterile swabs
    • 25 Extraction buffer vials
    • 1 Package insert and quick reference guide

    Specification:

    • Relative sensitivity: 84.4%, Relative specificity: 97%
    • Sample Type: Anterior Nasal swabs 
    • Detection Method: Colloidal Gold
    • Detection Time: 15 minutes

    Key Features:

    • FDA EUA Approved
    • Non-Invasive
    • Simple to use
    • No additional instrument required to read the results
    • Accessible, portable, and scalable option for COVID-19 testing
    • Cost-efficient

    Packaging Configuration:

    • 25 tests per kit, 500 tests per case, 12,000 tests per pallet

    Sienna-Clarity
    COVID-19 Antigen Rapid Test

    Sienna Rapid antigen test

    Each Kit Contains:

    • 25 Test devices
    • 25 Sterile nasopharyngeal swabs
    • 25 Buffer tubes
    • 1 Positive and 1 Negative control swab
    • 1 Work station
    • 1 Package insert
    • 1 Quick start guide

    Specification:

    Relative sensitivity: 87.5%, Relative specificity: 98.9%
    Sample Type: Nasopharyngeal swabs
    Detection Method: Colloidal Gold
    Detection Time: 5 minutes
    CPT Code: 86328-QW

    Key Features:

    FDA-EUA Authorized
    Non-Invasive
    Simple to use
    CLIA Waived
    No additional instrument required to read the results
    Accessible, portable, and scalable option for COVID-19 testing
    Cost-efficient

    Packaging Configuration:

    • 25 tests per kit, 1,225 tests per case, 9,800 tests per pallet (small), 14,700 tests per pallet (large)

    CareStart
    COVID-19 Rapid Antigen Test

    CareStart COVID-19 Antigen by AccessBio. Rapid test. Kit includes items for 20 tests.

    Each Kit Contains:

    • 20 Test devices
    • 20 Sterile swabs
    • 20 Extraction vials / caps
    • 1 Package insert

    Specification:

    • Relative sensitivity: 88.37%, Relative specificity: 100.0%
    • Sample Type: Nasopharyngeal and anterior nasal swabs
    • Detection Method: Colloidal Gold
    • Detection Time: 15 minutes

    Key Features:

    • FDA EUA Approved
    • Non-Invasive
    • Simple to use
    • No additional instrument required to read the results
    • Accessible, portable, and scalable option for COVID-19 testing
    • Cost-efficient

    Packaging Configuration:

    • 20 tests per kit, 640 tests per case, 10,240 tests per pallet (air shipment), 12,800 tests per pallet (truck / ocean shipment)

    GenBody
    COVID-19 Rapid Antigen Test

    GenBody COVID-19 AG test. Detection of SARS-CoV-2 antigen. This kit includes items for 25 tests. This is a rapid test.

    Each Kit Contains:

    • 25 Single-use test devices
    • 2 Bottles containing 9 mL of extraction solution
    • 25 Single-use extraction tubes
    • 25 Single-use dropper tips
    • 25 Single-use specimen sampling swabs (sterilized nasopharyngeal or anterior nasal swabs)
    • 1 External positive control swab
    • 1 External negative control swab
    • 1 Instructions for use (IFU)
    • 1 Quick reference instructions (QRI)

    Specification:

    • Relative sensitivity: 91.1%, Relative specificity: 100% (nasopharyngeal); Relative sensitivity: 92.31%, Relative specificity: 99.04% (nasal)
    • Sample Type: Nasopharyngeal and Anterior Nasal Swabs
    • Detection Method: Colloidal Gold
    • Detection Time: 15-20 minutes

    Key Features:

    • FDA EUA Approved
    • Non-Invasive
    • Simple to use
    • No additional instrument required to read the results
    • Accessible, portable, and scalable option for COVID-19 testing
    • Cost-efficient

    Packaging Configuration:

    • 25 tests per kit, 900 tests per case, 10,800 tests per pallet

    CareStart
    COVID-19 Rapid Antigen Home Test

    CareStart COVID-19 antigen home test by AccessBio. Kit includes 2 tests.

    Each Kit Contains:

    • 2 Test devices
    • 2 Sterile swabs
    • 2 Extraction vials & caps
    • 1 Individual factsheet
    • 1 Quick start guide

    Specification:

    • PPA: 87%, NPA: 98%
    • Sample Type: anterior nasal swabs
    • Detection Method: Colloidal Gold
    • Detection Time: 10 minutes

    Key Features:

    • FDA EUA Authorized
    • Non-Invasive
    • Detects all known COVID-variants
    • Simple to use
    • No additional instrument required to read the results
    • Cost-efficient

    Packaging Configuration:

    • 2 tests per kit, 464 tests per case, 9,280 tests per pallet

    FlowFlex
    COVID-19 Antigen Home Test

    FlowFlex COVID-19 Antigen Home Test. The package advertises that the kit is easy to use, accurate, and has quick results. The kit is made by ACON labs inc. This kit is for one test.

    Each Kit Contains:

    • 1 Test cassette
    • 1 Extraction buffer tube
    • 1 Disposable nasal swab
    • 1 Package insert

    Specification:

    • PPA: 93%, NPA: 100%
    • Sample Type: Nasal swab
    • Detection Method: Colloidal Gold
    • Detection Time: 15 minutes

    Key Features:

    • FDA EUA Approved – OTC Use
    • Non-Invasive
    • Simple to use
    • No additional instrument required to read the results
    • Accessible, portable, and scalable option for COVID-19 testing
    • Cost-efficient

    Packaging Configuration:

    • 1 test per kit, 300 tests per case, 6,000 tests per pallet

    iHealth
    COVID-19 Antigen Rapid Test

    iHealth Antigen Rapid test. Self-test at home in 15 minutes. This kit includes items for 2 tests.

    Each Kit Contains:

    • 2 COVID-19 Test cards
    • 2 Nasal swabs
    • 2 Pre-filled or empty tubes with sealed solutions
    • 1 Package insert

    Specification:

    • PPA: 94.3%, NPA: 95%
    • Sample Type: Nasal swab
    • Detection Method: Colloidal Gold
    • Detection Time: 15 minutes

    Key Features:

    • FDA EUA Approved – OTC Use
    • Non-Invasive
    • Simple to use
    • No additional instrument required to read the results
    • Accessible, portable, and scalable option for COVID-19 testing
    • Cost-efficient

    Packaging Configuration:

    • 2 tests per kit, 180 tests per case, 15,120 tests per pallet

    QuickVue
    COVID-19 Antigen Rapid Test – OTC Use

    QuickVue at home OTC COVID-19 rapid test. Fast, Easy, ready when you are. This kit includes items for 2 tests. Get results in 10 minutes

    Each Kit Contains:

    • 2 Test cassettes
    • 2 Sterile swabs
    • 2 Extraction tubes
    • 2 Buffers
    • 1 Package insert

    Specification:

    • PPA: 96.6%, NPA: 99.3%
    • Sample Type: Nasal swab
    • Detection Method: Colloidal Gold
    • Detection Time: 10 minutes

    Key Features:

    • FDA EUA Approved – OTC Use
    • Non-Invasive
    • Simple to use
    • No additional instrument required to read the results
    • Accessible, portable, and scalable option for COVID-19 testing
    • Cost-efficient

    Packaging Configuration:

    • 2 tests per kit, 180 tests per case, 2,700 tests per pallet

    BinaxNow
    COVID-19 Antigen Self Test

    BinaxNow COVID-19 antigen self test. Kit includes items for 2 tests. COVID-19 Ag Card with QR code. Made by Abbott

    Each Kit Contains:

    • 2 Test cassettes
    • 2 Sterile swabs
    • 2 Extraction tubes
    • 2 Buffers
    • 1 Package insert

    Specification:

    • PPA: 96.6%, NPA: 99.3%
    • Sample Type: Nasal swab
    • Detection Method: Colloidal Gold
    • Detection Time: 10 minutes

    Key Features:

    • FDA EUA Approved – OTC Use
    • Non-Invasive
    • Simple to use
    • No additional instrument required to read the results
    • Accessible, portable, and scalable option for COVID-19 testing
    • Cost-efficient

    Packaging Configuration:

    • 2 tests per kit, 12 tests per case, 1,728 tests per pallet

    Healgen
    COVID-19 Antibody Rapid Test

    Healgen Rapid Antigen test for COVID-19.

    Each Kit Contains:

    • 25 Individual sealed pouches (1 x Test cassette, 1 x Desiccant pouch)
    • 25 Disposable pipettes
    • Sample diluent
    • Instructions for use (IFU)

    Specification:

    • IgG sensitivity: 96.7%, specificity: 98.0%. IgM sensitivity: 86.7%, specificity: 99.0%.
    • Overall positive agreement rate of 96.7%, negative agreement rate of 97.0%.
    • Sample Type: whole blood sample, serum and plasma
    • Detection Method: Colloidal Gold
    • Detection Time: 10 – 15 minutes
    • Not suitable for Point of Care Testing
    • FDA EUA approved; CE Certified

    FaStep
    COVID-19 Antibody Rapid Test

    FaStep Rapid test for COVID-19

    Each Kit Contains:

    • 20 Test devices
    • 20 Disposable pipettes
    • 20 Alcohol prep pads
    • 20 Sterile safety lancets
    • Sample diluent
    • Instructions for use (IFU)

    Specification:

    • IgG sensitivity: 90.0%, specificity: 100.0%. IgM sensitivity: 100.0%, specificity: 98.8%.
    • Overall positive agreement rate of 80.8%, negative agreement rate of 100.0%.
    • Sample Type: Fingertip blood, whole blood sample, serum and plasma
    • Detection Method: Colloidal Gold
    • Detection Time: 10 – 15 minutes
    • Suitable for Point of Care Testing, CLIA waived
    • FDA EUA approved; CE Certified

    Packaging Configuration:

    • 20 tests per kit, 640 tests per case, 12,800 tests per pallet

    Get more information on Aurora’s  FDA/EUA Authorized Corona-virus (COVID-19) Rapid Test Kits:

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