INDICAID® COVID-19 Rapid Antigen Test – Instant Testing
- Point of Care Rapid Antigen Test
- Facilities must be CLIA Waived
- Clia Waived certificate is required before shipping
- Rapid results within 15 minutes – 25 Tests Per Box
- No training or equipment needed
- FOR QUANTITY PRICING CALL 1.800.921.8241
AS LOW AS $6.85ea IN QUANTITY
FREE SHIPPING ON ALL ORDERS
Please note: Shipping will commence approx. 1/21 – 1/25.
FOR BULK ORDERS OVER 20,000 TESTS CALL: 1.800.921.8241
or email: [email protected]
INDICAID®COVID-19 Rapid Antigen Test – Instant Test
The fast covid-19 antigen test has been classified as an emergency use authorisation by the Food and Drug Administration (FDA) (EUA). Because of this classification, the test can be commercially disseminated to pharmacies and other points of care (POC) where it can be administered. Furthermore, the tests to look for the SARS CoV-2 antigen in the specimens can only be performed by labs certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The virus that causes the Covid-19 sickness is officially known as SARS CoV-2.
Rapid Antigen Covid Test
The Covid-19 pandemic is in in its third year, and there are no signs of it slowing down. As the virus that causes serious respiratory illness spreads, it mutates into versions that evade the protective measures we’ve put in place. As a result, millions of people have perished, and many more will get sick. While there are excellent vaccines that prevent most of us from being ill and visiting the hospital, immunizations do not prevent us from becoming infected with the virus. Understanding how Covid-19 spreads is the best thing we can do to avoid it. Then we may take deliberate steps to halt the pandemic’s spread and put an end to it. Ovus Medical is glad to present the Covid-19 Rapid Antigen Test.
INDICAID™ COVID 19 Rapid Antigen Test
The INDICAID™ COVID-19 Rapid Antigen Test is intended for use by trained clinical laboratory personnel and medical and healthcare personnel in Point of Care (POC) settings. The INDICAID™ COVID-19 Rapid Antigen Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.
The INDICAID™ COVID-19 Rapid Antigen Test is a non-invasive rapid point-of-care diagnostic test for the qualitative detection of SARS-CoV-2 antigen in respiratory specimens. Each INDICAID™ COVID-19 Rapid Antigen Test is single-use and can analyze one anterior nasal swab sample. The total time required to perform one
test is approximately 20 minutes from clinical specimen collection to result.
The INDICAID™ COVID-19 Rapid Antigen Test is a lateral flow immunoassay for the qualitative detection of nucleocapsid protein antigen from SARSCoV-2 in direct anterior nasal swab specimens from individuals with symptoms or other epidemiological reasons to suspect COVID-19 within the first five (5) days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours between tests.
Anterior nasal swab specimens may be collected by a healthcare provider (HCP) or self-collected (by individuals 18 years of age or older, under the supervision of an HCP). Testing is limited to laboratories certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, 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.
25 Individually foil pouched test device
25 Vial with cap and integrated dispensing tip, containing 400 μL of buffer solution.
Nasal Swabs 25 Individually wrapped, sterile specimen collector
Package Insert 1 Instructions for Use
1 Quick Reference Guide
Instructions for use and Quick Reference Guide
Summary and Explanation of the Test
- Professional use only. Clia waived facility’s only.
- For in vitro diagnostic use only
- For prescription use only.
- Results in 15 minutes.
- No equipment or training needed.
- Detect lower viral load samples against competitive products.
- INDICAID Covid tests available in bulk / quantity.
• Nasal swab specimens may be self-collected by the patient if the collection procedure is instructed and observed by a healthcare professional.
• Process the collected specimen immediately after collection.
• Use only the swab provided in the INDICAID™ COVID-19 Rapid Antigen Test Kit.
How does it work
The INDICAID™ COVID Antigen Test is an immunochromatographic lateral flow assay that detects antigen from SARS-CoV-2 in direct anterior nasal swab samples from patients suspected with COVID-19 by their healthcare provider within the first five (5) days of symptom onset using very sensitive antibodies. Two separate lines of SARS-CoV-2 specific antibodies and a control antibody are mounted onto a nitrocellulose membrane substrate.
The test line (T) region contains monoclonal anti-SARS-CoV-2 antibodies and the control line (C) region contains polyclonal control antibodies. Polyclonal and monoclonal anti-SARS-CoV-2antibodies conjugated with red-colored colloidal gold particles are used to detect the SARS-CoV-2 antigen.
During the test, the swab containing patient sample is placed and mixed in a Buffer Solution Vial. That Buffer Solution is then applied to the sample well of the test device. If SARS-CoV-2 antigen is present, it will bind to the antibody-gold Page 5 of 22 IC04QS2021 | PI-2110400ENG | Rev B| November 2021 conjugate forming an immunocomplex.
The immunocomplex will then travel across the strip via capillary action towards the test line.
The immunocomplex will then bind to the anti-SARS-CoV-2 antibodies at the test line (T), forming a visible red-colored line to indicate detection of antigens. If SARS-CoV-2 antigens are not detected in the sample, no color will appear at the test line (T).
The control (C) line is used for procedural control and should appear regardless of the test result. The appearance of the control line (C) serves to ensure the test is performing properly and the test result is valid.
Please refer to the complete INDICAID™ COVID-19 Antigen Quality Controls Instructions For Use.
1. Remove a new Swab and Test Device from their packaging. Place the Test Device on a horizontal (flat) surface for running the test.
2. Hold a new INDICAID™ COVID-19 Antigen Positive Control Vial vertically and open the cap.
3. Dip the new Swab into the Positive Control Vial, making sure that the Swab head is fully submerged in the solution. Roll the Swab head around in the solution to ensure the swab is wetted. Remove the Swab from the Vial.
4. Test the Swab immediately performing the same steps as described in section “Test Procedure for Patient Swabs” above.
Specimen Collection, Handling, and Transport
The INDICAID™ COVID-19 Rapid Antigen Test should only be used with the swabs provided in the kit to collect direct nasal samples according to the procedures in these Instructions for Use. Specimens should be tested immediately after collection for best performance. Do not transport or store specimens for later testing. Inadequate specimen collection or improper handling, storage, and transport may lead to incorrect results.
Do not test specimens 2 hours after collection.
Refer to the CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19)
Reading the results
Test results are interpreted visually, without the aid of instruments.
What is Coronavirus?
Coronaviruses are a kind of infection. There are a wide range of varieties. A recently perceived coronavirus, SARS-CoV-2, has caused an overall pandemic of respiratory sickness, called COVID-19.
Coronavirus Symptoms include: Cough. Fever. Brevity of breath. Muscle hurts. Sore throat. Unexplained loss of taste or smell. Diarrhea. Migraine.
Seven human coronaviruses (HCoVs) have been so far recognized, prominently HCoV-229E, HCoV-OC43, HCoV-NL63, HCoV-HKU1, genuine intense respiratory disorder coronavirus (SARS-CoV), Middle East respiratory condition coronavirus (MERS-CoV) and the novel coronavirus (2019-nCoV, a.k.a. SARS-CoV-2).
In agreement to the profoundly pathogenic SARS-CoV, MERS-CoV, and 2019-nCoV, the four purported basic HCoVs for the most part cause moderate upper-respiratory tract sickness and add to 15%–30% of instances of regular colds in human grown-ups. Extreme and dangerous lower respiratory tract diseases can in some cases happen in the old, newborn children and additionally immunocompromised patients.