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
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
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
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
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
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
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
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
INDICAID
COVID-19 Antigen At-Home Test
Each Kit Contains:
Sold in 12pk or 2pk configuration
• 2/12 test devices
• 2/12 buffer solution vials
• 2/12 sterile nasal swabs
• Instructions for use
• Quick reference guid
Specification:
- 81.7% Sensitivity
- 99.4% Specificity
- Sample Type: Nasal swab
- Detection Method: Colloidal Gold
- Detection Time: 20 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 Pack Configuration
Kit: 2 tests / 0.1 lb. / 8″ x 1″ x 2.6″
Case: 252 tests / 126 kits / 16.3 lbs. / 22.4″ x 16.9″ x 8.7″
Pallet: 6,048 tests / 3,024 kits / 389 lbs. / 40″ x 40″ x 58″ - 12 Pack Configuration
Kit: 12 tests / 0.4 lb. / 8.1″ x 3.6″ 2.6″
Case: 432 tests / 36 kits / 16.3 lbs. / 22.4″ x 16.9″ x 8.7″
Pallet: 10,368 tests / 864 kits / 40″ x 40″ x 58″
OHC
COVID-19 Antigen Self Test
Each Kit Contains:
- 2 Test cassettes
- 2 Sterile nasal swabs
- 2 Extraction buffer tubes
- 2 Tube filter caps
- 1 User manual quick guide
- 1 box (tube holder)
FEATURES & BENEFITS:
- Detects both Omicron and Delta variants
- Children starting at the age of 14 can self test. Children from ages 2 to 13 require the help of an adult
- Uses minimally invasive shallow nasal swab
- Easy visual read
- Fast results in ~ 15 minutes
- Relative Sensitivity: 91% ( 95% CI: 82.8 to 95.6%); Relative Specificity: 99% (95% CI: 95.2 to 99.6%)*
- Room temperature storage
Packaging Configuration:
- 2 tests per kit
Healgen
COVID-19 Antibody Rapid 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
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