CareStart™ COVID-19 Antigen Home Test - 2 Tests Each
- Usually Ships in 1 Business Day
- 0.30 LBS
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CareStart™ COVID-19 Antigen Home Test - 2 Tests Each
The CareStart™ COVID-19 Antigen Home Test is a rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from individuals with or without symptoms or other epidemiological reasons to suspect a COVID-19 infection when tested twice over two or three days with at least 24 hours and not more than 48 hours between tests. This test is authorized for non-prescription home use with self -collected direct anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal swab samples from individuals aged 2 years or older.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. The antigen is generally detectable in anterior nasal swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses and the agent detected may not be the definite cause of disease. Individuals who test positive with the CareStart™ COVID-19 Antigen Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.
Negative results should be treated as presumptive and confirmation with a molecular assay for patient management, may be performed if necessary. 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 an individual’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 COVID-19, such as, an individual with a close contact with COVID-19 or with suspected exposure to COVID-19 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 COVID-19, such as in individuals without known exposures to COVID-19 or residing in communities with low prevalence of infection.
Directions: The CareStart™ COVID-19 Antigen Home Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in self- collected direct anterior nasal (nares) swab specimens.
Nasal swabs require a sample preparation step in which the sample is eluted into the extraction buffer solution. Extracted swab sample is added to the sample well of the test device to initiate the test. When the swab sample migrates in the test strip, SARS-CoV-2 viral antigens bind to anti-SARS-CoV-2 nucleocapsid protein antibodies conjugated to indicator and capture particles in the test strip forming an immune complex. The immune complex is then captured by the test line on the nitrocellulose membrane as it migrates through the strip. The user should perform the test following the in-app self -paced, step-by-step instructions or Quick Reference Instructions.
Test results are interpreted visually at 10 minutes after sample loading followed by the instructions. The presence of two colored lines in the control line region “C” and test line region “T” indicates COVID-19 positive. The presence of one colored line in the control line region “C” indicates COVID-19 negative. No appearance of a colored line in the control region “C” indicates an invalid test. Results should not be read after 15 minutes.
Warnings: For in vitro diagnostic use only. This product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA).
This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.
Children aged 13 years old and younger should be tested by a parent or legal guardian. Wear a safety mask or other face-covering when collecting anterior nares swab specimen from a child or another individual.
Wash hands thoroughly for at least 20 seconds before and after handling nasal swab samples.
In order to obtain accurate results, the user must follow the instructions for use. Immediately use after opening the test device in the pouch.
Keep the test device on a flat surface during the testing.
Keep testing kit and kit components away from children and pets before and after use. 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 nasal cavity when collecting specimens.
Inadequate or inappropriate sample collection, storage, and transport can result in incorrect results. If specimen storage is necessary, swabs can be placed into the extraction vial for up to four hours. Specimens should not be stored dry.
When collecting a nasal swab sample, use only the Nasal Swab provided in the kit.
Keep foreign substances and household cleaning products away from the test during the testing process. Contact with foreign substances and household cleaning products may result in an incorrect test result.
Use appropriate precautions in the collection, handling, storage, and disposal of patient samples and used kit contents.
Handle all specimens as though they contain infectious agents.
Do not operate your test outside of storage conditions.
Do not use on anyone under 2 years of age.
Do not close the App during processing as it may cause an error and you will need a new test kit.
Do not interpret the test result before 10 minutes and after 15 minutes starting the test. Do not use on anyone who is prone to nosebleeds or has had facial or head injury/surgery in the last 6 months.
Do not use if the test device package is damaged.
Do not touch the tip (specimen collection area) of the swab.
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.
Do not interchange kit contents from different lots.
Do not re-use any contents in the kit as they are single-use only.
Eye and skin contact with the extraction solution should be avoided.
Extraction solution should not be ingested.
The extraction solution in the vial contains potentially harmful chemicals (see table below). If the solution contacts the skin or eye, flush with copious amounts of water.
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