The only COVID-19 Antigen Rapid Tests made in the USA
The SARS-CoV-2 is a pandemic, coronavirus, COVID-19, as declared by the World Health Organizaiton (WHO). Accurate and quick testing is the single most important aspect of helping prevent the spread of the disease. Detecting the asymptomatic and clinical cases of the coronavirus are of equal importance.
The CareStartTM COVID-19 Antigen Test allows effective screening on a large scale. It is intended as a point-of-care (POC) designated test with a 10 minute testing point.
The Access Bio, Inc. CareStartTM COVID-19 Antigen Test is a lateral flow immu- nochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal swab specimens directly collected from symptomatic individuals who are suspected of COVID-19 by their healthcare provider.
As an intended point-of-care (POC) designated test performed by medical professionals with a 10 minutes processing time, CareStartTM COVID-19 Antigen Test helps provide critical answers about active infections to patients and healthcare workers alike.
The CareStart™ COVID-19 Antigen Rapid Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swab specimens directly collected, or collected in BD universal transport media, from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset. 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, high or waived complexity tests. This test 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. Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen.
The antigen is generally detectable in nasopharyngeal swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status.
Positive results do not rule out a bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. Negative results are presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed. 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. The CareStart™ COVID-19 Antigen is intended for use by medical professionals or trained operators who are proficient in performing tests and trained clinical laboratory personnel or individuals trained in point of care settings. The CareStart™ COVID-19 Antigen is only for use under the Food and Drug Administration’s Emergency Use Authorization.
|Contents Name||Quantity (in a kit)||Description|
|Test device||20 each||Foil pouched test device containing one test strip which is encased in plastic device cassette.|
|Extraction vial/cap||20 vials and caps||The extraction vial contains 400 ul extraction buffer solution|
|Nasopharyngeal swab||20 each||Swabs for nasopharyngeal specimen collection|
|Positive control swab||1 each||Recombinant SARS-CoV-2 nucleocapsid protein antigen is dried on the foam-tipped head|
|Negative control swab||1 each||Blank Universal Viral Transport media (BD UVT) is dried on the foam-tipped head|
|Package insert||1 each||Instructions for use|
|Quick reference Instructions||1 each||Quick reference instructions (QRI)|
The following materials are needed but not provided:
– For prescription and in vitro diagnostic use only.
– This test has not been FDA cleared or approved; the test 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, high or waived complexity tests. This test 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 test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
– This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
– As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
– Immediately use after opening the test device in the pouch.
– In order to obtain accurate results, the test must follow this package insert.
– Excess blood or mucus on the swab specimen may interfere with test performance and may yield a false-positive result. Avoid touching any bleeding areas of the nasopharynx when collecting specimens. Do not interpret the test result before 10 minutes and after 15 minutes starting the test.
– Inadequate or inappropriate sample collection, storage, and transport can result in incorrect results.If specimen storage is necessary, swabs can be placed into extraction buffer for up to four hours. Specimens should not be stored dry.
– Do not use if the test device package is damaged.
– Do not use the kit contents beyond the expiration date.
– Do not eat, drink, or smoke in the area where the specimens and kit contents are handled.
– Use appropriate precautions in the collection, handling, storage, and disposal 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 the extraction buffer contacts the skin or eye, flush with copious amounts of water.
– Handle all specimens as though they contain infectious agents.
– Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.
– Reagents contain sodium azide, which is harmful if inhaled, swallowed, or exposed to skin. Contact with acids produces a very toxic gas. If there is contact with skin, wash immediately with plenty of water. Sodium azide may react with lead and copper plumbing to form highly explosive metal azides. On disposal, flush with a large volume of water to prevent azide build-up.
– Do not interchange kit contents from different lots.
– Do not re-use any contents in the kit as they are single-use only
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