INDICAID® PROFESSIONAL ADVANTAGE
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EUA 210259
For In Vitro Diagnostic Use Only
Professional Use Only
*CLIA Number Required for Purchase
The INDICAID® (Professional) COVID-19 Rapid Antigen Test (FDA EUA) is a lateral flow immunoassay designed for the qualitative detection of SARS-CoV-2 antigens in direct nasal swab samples.
Quick: With INDICAID®, users can expect quick results in just 20 minutes.
Easy: User-friendly testing. No additional equipment or training is required.
Simple Sampling: INDICAID® comes with intuitive vials to obtain self-collected shallow nasal samples.
Bulk Testing: Our rapid COVID-19 test offers bulk sample collection and testing, great for high-volume screening.
‘How To Use’ Video
INDICAID® OMICRON DETECTION STATEMENT
“PHASE Scientific continuously monitors the performance
of our test against emerging COVID-19 variants. To date, in-house analytical
studies have not identified any variants of concern that have an impact to the
performance of INDICAID, including Omicron sub-variants BA.4 and BA.5.”
PREFERRED BY PROFESSIONALS
BATCH-COLLECTION & BULK -TESTING OF INDIVIDUAL SAMPLES
With our intuitive vial design, INDICAID® PoC (Point-of-Care) COVID-19 Rapid Antigen Tests allow for the aggregate collection of multiple specimens followed by batch-testing of individual samples up to two (2) hours after collection, in the laboratory setting.
QUICK & EASY TESTING
DOWNLOADS
INDICAID® PoC (Professional) COVID-19 Rapid Antigen Test Downloads
INDICAID® Product Gallery
Reading Test Results
You can find the results diagram in the enclosed Instructions For Use (IFU) found in your INDICAID® box.
Do You Have Questions? Consult your healthcare professional administering your tests for results, or check our FAQ’s.
External Quality Controls ( 5+/5- )
The INDICAID® COVID-19 Antigen Quality Controls are external liquid quality controls. The controls are specifically formulated and manufactured to ensure that the test’s reagents and materials are working and that the test procedure is correctly performed. The Quality Controls consist of positive and negative control samples that should be run once with every new lot, shipment, and each new user, using the test procedure provided.
It is the responsibility of each laboratory or healthcare setting using the INDICAID® COVID-19 Rapid Antigen Test to establish an adequate quality assurance program to ensure the performance of the test kit under its specific locations and conditions of use. Quality control requirements should be followed in conformance with local, state, and federal regulations or accreditation requirements and the user laboratory’s standard quality control procedures.
For over 100 boxes (5+/5-) contact our sales professionals.
Principle
The INDICAID® COVID-19 Rapid Antigen Test detects antigens from SARS-CoV-2 virus and can be used for COVID-19 screening during active infection.
Specifications
| FEATURES | SPECIFICATIONS |
|---|---|
| PRODUCT CODE | EUA 210259 |
| ITEMS PER BOX | 25 |
| SPECIMEN TYPE | Direct Anterior Nasal Swab |
| INTENDED USE | The INDICAID® COVID-19 Rapid Antigen Test is a rapid lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. The test is performed by a CLIA Certified Health Care Provider (HCP) using direct anterior nasal swab specimens from suspected COVID-19 individuals within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests. For individuals without symptoms or other epidemiological reasons to suspect COVID-19, it is authorized when tested at least three times over five days with at least 48 hours between tests. Anterior nasal swab specimens may be collected by an HCP or self-collected by individuals 18 years of age or older, under the supervision of an HCP.
The INDICAID® COVID-19 Rapid Antigen Test is only for in vitro diagnostic use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been FDA cleared or approved. |
| STORAGE CONDITION | 36º-86ºF (2º-30ºC) Do not freeze. Avoid direct sunlight. |
| SHELF LIFE | 12 Months |
| ACCURACY | Sensitivity 88.9%; Specificity 96.8%; Overall accuracy 95.6% |
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Frequently Asked Questions
The shelf-life of the INDICAID® test is one (1) year from the date of manufacture. The one (1) year expiration date is provided on the label of the outer box.
Data from our US multi-center clinical study demonstrates similar performance for detection of the COVID-19 Omicron variant compared to the original COVID-19 strain.
The swab test method is utilized by the biomedical community for the collection of upper-respiratory specimens for molecular and rapid antigen testing. The CDC supports and promotes this testing method in light of the current COVID-19 pandemic climate for its practicality, simplicity, and efficiency of gathering much-needed data in bulk.
Yes. Insurance, Medicare, and Medicaid cover rapid antigen tests.
The Insurance Code is: U003
The Medicaid CPT Code: 87426, 87811QW
The Medicare CPT Codes: 87635 | 86769 | 86328
There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests detect proteins from the virus. Antigen tests are very specific for the virus but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. Due to the lower sensitivity of antigen tests, there is a higher chance this test will give you a false negative result when you have COVID-19 than a molecular test would.
If your antigen test result is negative, serial testing should be performed at least twice over three days (with 48 hours between tests) for symptomatic individuals and three times over five days (with at least 48 hours between tests) for asymptomatic individuals. You may need to purchase additional tests to perform this serial (repeat) testing.
Due to the lower sensitivity of antigen tests, there is a higher chance this test will give you a false negative result when you have COVID-19 than a molecular test would.
Discuss with your healthcare provider whether a molecular test would help with your care, and when you should discontinue home isolation if necessary. If a molecular test is not available, the CDC recommends that you should stay home.
Refer to the CDC website for most updated guidelines: https://www.cdc.gov/coronavirus/2019-ncov/your-health/isolation.html
Antigen tests are known to be less sensitive than molecular tests that detect viral nucleic acids. Negative results should be treated as presumptive and may be confirmed with a molecular assay, if necessary, for patient management. Results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19.
- This test does not differentiate between SARS-CoV and SARS-CoV-2 viruses, so you may receive a positive result but have a different coronavirus that does not cause COVID-19.
- It is possible to test a person too early or too late during COVID-19 to make an accurate diagnosis. The amount of antigen in a sample may decrease as the duration of illness increases. Negative results from patients with symptom onset beyond 5 days should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management.
- Improper handling of the test kit not according to guidelines may yield imprecise test results.
- When an incorrect result is suspected, it is important that you engage with your healthcare provider to help you understand the situation and evaluate your next steps.
A negative test result means that proteins from the virus that causes COVID-19 were not found in your sample. However, it is possible for this test to give a negative result that is incorrect (false-negative) in some people with COVID-19. Your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you.
Serial testing should be performed in individuals with negative results at least twice over three days (with 48 hours between tests) for symptomatic individuals and three times over five days (with at least 48 hours between tests) for asymptomatic individuals. You may need to purchase additional tests to perform this serial (repeat) testing.
A positive test result means that proteins from the virus that causes COVID-19 were found in your sample. This means that it is likely that you have COVID-19, even if you do not have any symptoms. There is also a very small chance that this test can give a positive result that is incorrect (a false-positive), particularly when used in a population without many cases of COVID-19. Your healthcare provider will discuss the next steps with you and how to best care for you based on your medical history and symptoms.
The INDICAID® COVID-19 Rapid Antigen Test is for diagnosis only and is safe to use, with no long-term impact on human health.
Potential risks include:
- Possible discomfort or other complications that can happen during sample collection.
- Possible incorrect test result (see below for more information).
Potential benefits include:
- The results, along with other information, can help your healthcare provider make informed recommendations about your care.
- The results of this test may help limit the spread of COVID-19 to your family and those you come in contact with.
For detailed information see the “Warnings, Precautions, and Safety Information” section of the IFU Instructions For Use.
INDICAID’s intuitive design allows the collection of multiple samples within a very short timeframe, followed by bulk-testing of samples within only two hours.
The test is performed by a CLIA Certified Health Care Provider (HCP) using direct anterior nasal swab specimens from suspected COVID-19 individuals within the first five (5) days of symptom onset. Anterior nasal swab specimens may be collected by an HCP or self-collected by individuals 18 years of age or older, under the supervision of an HCP.
This test can be administered with no equipment or training needed. The test has high sensitivity and can detect lower viral load samples against competitive products. This test has been granted Emergency Use Authorization (EUA) by the United States Food and Drug Administration.
The INDICAID® COVID-19 Rapid Antigen Test is a lateral flow immunoassay designed for the qualitative detection of SARS-CoV-2 antigens. Antigen tests are designed to detect proteins from the virus that causes COVID-19 through swab specimens taken from the patient’s nose.
Testimonials
Accurate, fast & convenient! I thought maybe I was coming down with COVID. I took a test at a clinic, before going to see my parents, and thankfully, my test came out negative! INDICAID® gave me peace-of-mind! It’s fast and easy. Thx.
We were able to return-to-work safely by offering our employees an easy way to frequently test. INDICAID® and our CLIA Certified Health Care Personnel keeps us up and running safely.
The benefits of antigen testing is its speed, sensitivity and ease-of-use, which can help reduce community transmission of COVID-19.