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Indicaid™ COVID-19 Rapid Antigen Test

Indicaid™ COVID-19 Rapid Antigen Test
Indicaid™ COVID-19 Rapid Antigen Test
Out Of Stock
Indicaid™ COVID-19 Rapid Antigen Test
Indicaid™ COVID-19 Rapid Antigen Test
Indicaid™ COVID-19 Rapid Antigen Test

For Rapid Detection of SARS-CoV-2 Antigen

  • FDA approved & over the counter sold
  • https://www.fda.gov/media/151215/download
  • 25 tests/box, 18 boxes/case
  • Minimum order is 1 box (25 tests)
  • $371.25 per box deliver anywhere in USA, (exception of HI and AK)
  • Special order only while supplies last
  • ***Manufacture date Jan 2022 and have a 5 month shelf life.***

The INDICAID™ COVID-19 Rapid Antigen Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARSCoV-2 in direct anterior nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider 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 and no more than 48 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.

The INDICAID™ COVID-19 Rapid Antigen Test does not differentiate between SARS-CoV and SARS-CoV-2 viruses.

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in anterior nasal swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or coinfection with other viruses. Additional confirmatory  testing with a molecular test for positive results may be necessary if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

Negative results should be treated as presumptive and may be confirmed with a molecular assay, if necessary, for patient management. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative 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.  For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with a close contact with COVID-19 or with suspected exposure to COVID-19 and/or in communities with high prevalence of infection. Additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection.

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.

Summary and Explanation of the Test

Coronaviruses are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as MERS and SARS-CoV. A novel coronavirus (SARS-CoV-2) was discovered in December 2019 and has resulted in millions of confirmed human infections worldwide. COVID-19, the disease brought on by the virus, produces symptoms in infected patients that are similar to the other viral respiratory diseases including fever, cough, and shortness of breath. The median incubation time is estimated to be approximately 5 days with symptoms estimated to be present within 12 days of infection.  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.

Principles of the Procedure

The INDICAID™ COVID-19 Rapid Antigen Test is an immunochromatographic lateral flow assay that uses highly sensitive antibodies to detect antigen from SARS-CoV-2 in direct anterior nasal swab samples from patients who are suspected of COVID-19 by their healthcare provider within the first five (5) days of symptom onset. SARS-CoV-2 specific antibodies and a control antibody are immobilized onto a nitrocellulose membrane support as two distinct lines. 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-2 antibodies 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 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.

The INDICAID™ COVID-19 Rapid Antigen Test is validated for use from direct specimens testing without transport media.

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  • Quantity in Stock:: Out Of Stock
  • Model: RAPIDCOVID
  • JAN: D
Product Views: 365
$371.25