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.

    Spring Health
    COVID-19 Rapid Antigen Test

    spring-antigen-test-poc

    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)

    INDICAID
    COVID-19 Antigen Rapid Test

    indicaid-rapid-antigen-test

    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-clarity-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

    care-start-antigen-test

    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

    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

    care-start-at-home-antigen-test

    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-antigen-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

    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

    quick-vue-at-home-rapid-antigen-test

    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

    binax-antigen-test

    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-antibody-test

    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-antibody-test

    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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