INDICAID COVID-19 Rapid Antigen PoC Test
INDICAID® Rapid Antigen Point-of-Care (PoC) Professional Tests are your reliable indicator for Covid-19 in the laboratory, office, factory or warehouse, as well as when attending lifestyle events or when traveling abroad.
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. The test must be administered or supervised by a CLIA certified technician, and a CLIA number is required for purchase.
THE INDICAID ADVANTAGE
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Quick: With INDICAID®, users can expect quick results in just 20 minutes.
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Easy: User-friendly testing. No additional equipment or training is required.
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Simple Sampling: INDICAID® comes with intuitive vials to obtain self-collected shallow nasal samples.
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Bulk Testing: Our rapid COVID-19 test offers bulk sample collection and testing, great for high volume screening.
BATCH-COLLECTION & BULK TESTING OF INDIVIDUAL SAMPLES
With our intuitive vial design, INDICAID® Rapid Antigen PoC (Point-of-Care) Professional 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
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Gently swab and collect: Tilt your head back. The technician will gently insert the swab about 1 inch into one of your nostrils. Rub the swab against the walls of one of your nostrils 4 times in a large circular path. Repeat with your other nostril.
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Insert swab and stir: Remove the entire cap. Stir the swab into the buffer solution 20 times. Throw away the swab and screw back the cap.
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Apply sample on test device: Hold the vial vertically. Squeeze and drip 3 drops of the solution into the circular opening (s) of the test device.
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Read Results: Leave for 20 minutes, return, and read the results. DO NOT read after 25 minutes.
CLINICAL PERFORMANCE
This product is for Professional Use in the United States of America, and needs to be administered or supervised by a CLIA Certified Professional. The US FDA has extended its 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.
Following Clinical Analysis of our CE version diagnostic, our CE Marked End-Point Test Performance is as follows:
Sensitivity (PPA) 89.1%
SPECIFICATIONS
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PRODUCT CODE: EUA 210259
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ITEMS PER BOX: 25
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SPECIMEN TYPE: Direct Anterior Nasal swab
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INTENDED USE: Qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swab samples from individuals who are suspected of COVID-19 by their healthcare provider within the first five (5) days of symptom onset, or within 2 to 3 days of potential exposure to a person suspected of being infected with COVID-19.
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STORAGE CONDITION: 36º - 86ºF (2º-30ºC) Do not freeze. Avoid direct sunlight.
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SHELF LIFE: 12 Months
VARIANTS
Product performance against new variants is evaluated on an ongoing basis.
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Effective in Detecting Omicron Variant (B.1.1.529) and specific variants of new coronavirus.
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Detectable variants include Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), Delta (B.1.617.2), Delta Plus (AY.1 and AY.2), and Omicron (B.1.1.529)
QUALITY CONTROLS
It is the responsibility of each laboratory or healthcare setting to ensure quality assurance. 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. (Controls sold separately)
Ask about our Quality Control product options.
EXPIRATION DATE
NOTE: Expiration Date: If you receive a box that has an expiration date that has passed, please do not be concerned. The FDA has granted an extended expiration life by 6 months from the expiration date printed on the back of the box for these tests. The shelf-life for all lots of INDICAID with the initial prefix 21SXXXX ND LOTS 22S0001 - 22S0100 may be extended by (6) months from the expiration date printed on the product packaging.
CLIA INFORMATION
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. CDC, in partnership with CMS and FDA, supports the CLIA program and clinical laboratory quality. Learn more about CLIA.
HOW TO USE INDICAID PoC
This “How-To-Use” video describes step-by-step how CLIA certified healthcare professionals properly conduct the INDICAID® COVID-19 Rapid Antigen Test, and read the results.
If you’ve received a test and have questions, please contact the healthcare provider that administered your test.
READY TO BUY?
Call +1.305.978.4590 or email us at info@consortiummiami.com to place your order today.
ABOUT PHASE SCIENTIFIC
PHASE Scientific is a high-growth biotech company founded by bioengineers from UCLA. They build tools that empower people by giving them better information about their health. With office and warehouses in Los Angeles, California, Sales & Marketing Office in Atlanta, Georgia, and corporate headquarters in Hong Kong, their global footprint includes R&D and manufacturing facilities in Southern California and offices in Mainland China.
