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INDICAID COVID-19 Test Kits - POC
INDICAID COVID-19 Ag Rapid Test
Overview
INDICAID™ is a non-invasive, rapid point-of-care diagnostic tool that is the simplest, quickest, and cheapest method of detecting the SARS-Cov-2 antigen in individuals. INDICAID’s portability, ease-of-use, and capability for self-collection and batch testing also make it one of the most efficient ways to screen populations en masse.
- EASY: User friendly testing, no equipment, or training required
- FAST: Visual results in just 20 minutes
- AUTHORIZED: US FDA Emergency Use Authorization (EUA) and CE marked SIMPLE: Intuitive process for self-collected shallow nasal samples
- CONVENIENT: Allows sample batch collection and bulk testing
The US FDA has extended their emergency use authorization (EUA) for the INDICAID™ COVID-19 Rapid Antigen Test to cover serial testing for asymptomatic individuals in a recent update. The update extends the use of INDICAID™ as a screening test, providing an additional
accurate and reliable testing option for schools, workplaces, and communities.
“It busts the myth that antigen tests could only detect symptomatic
patients and shows that high-quality antigen tests can be sensitive, accurate, and reliable to be used for population screening.”
Product performance against new variants are evaluated on an ongoing basis.
Storage and Stability
- Store the test kit in a cool, dry place between 2-30°C (36-86°F). Do not freeze. Avoid direct sunlight.
- Kit contents are stable until the use by date printed on the product label and outer packaging. Do not use after the date indicated.
- All components in this test kit should remain sealed until ready for use.
FDA Authorization - EUA
- This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Packaging
- Box contains 25 tests
- Case contains 18 boxes (450 tests)
- Pallet contains 360 cases (9,000 tests)
25-kit package contents
- 25 test devices
- 25 buffer solution vials
- 25 nasal swabs
- 25 filter caps
- 1 product insert
- 1 quick reference guide
Materials required but not provided:
- Timer
- External Positive and Negative Controls (sold separately: P/N: 2110410/2110420)
- Any necessary personal protective equipment (PPE)
PRECAUTIONS AND WARNINGS
- For in vitro diagnostic use only.
- For prescription use only.
- In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the CLIA that meet the requirements to perform moderate complexity, high complexity or waived tests. This product 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.
- This product is only authorized for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
- In the USA, the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
- Laboratories within the United States and its territories are required to report all positive results to the appropriate public health laboratories.
- Do not use this kit beyond the use by date printed on the product label.
- Do not use if the Test Device package is damaged.
- All components in this test kit should remain sealed until ready for use.
- Immediately use after opening and removing the Test Device from the pouch.
- To obtain accurate results, the test must be performed as indicated in the Instructions for Use.
- Do not interpret the test result before 20 minutes or after 25 minutes, following application of the sample to the Test Device.
- All kit components are single use only. Do not re-use any kit components or mix components from different kit lots or different products.
- Do not store specimens in viral transport media for specimen storage.
- Do not eat, drink, or smoke in the area where the specimens and kit contents are handled.
- Use appropriate precautions when collecting, handling, storing, and disposing of patient samples and used kit contents.
- Dispose of used contents as biohazardous wastes in accordance with federal, state, and local requirements.
- Nitrile or latex gloves should be worn when performing this test.
- If Buffer Solution comes into contact with eyes and/or skin, flush abundantly with water.
- Handle all specimens as though they contain infectious agents. Wear protective clothing such as laboratory coats, disposable gloves, and eye protection when specimens are collected and evaluated.
- Test Devices used in a laminar flow hood or in areas with high air flow should be covered during test development to ensure proper sample flow.
For additional information on hazard symbols, safety, handling and disposal of the components within this kit, please refer to the Safety Data Sheet (SDS) from the download section below.