care start rapid antigen test instructions

CareStart COVID- 19 Rapid Antigen 20 TESTS PER KIT COMPONNTS. CareStart COVID-19 Antigen Test Product Insert RCHM-02071 Manual and Guide For use under the Emergency Use Authorization EUA only For in vitro diagnostic use only For prescription use only COVID-19 Antigen Rapid Diagnostic Test for the Detection of SARS-CoV-2 Antigen Package Insert Instructions for Use RCHM-02071.


Carestart Covid 19 Antigen Access Bio

CareStart has created a COVID-19 Rapid Antigen Test designed for qualified medical professionals that can provide results in ten minutes for symptomatic patients as part of their point of care services.

. Fast and easy to self-test at anywhere Easy to interpret the results using mobile application Qualitatively detect the SARS-CoV-2 nucleocapsid protein Use for nasal swab specimen Fast results only in 10 minutes Identify individuals current infection status to COVID-19 Access Bio Carestart Antigen Home Test Kit - Instructional Video. RCLM02572 Data and amounts posted are strictly for informational purposes only. CareStart COVID-19 Antigen test - Instructions for Use For use under the Emergency Use Authorization EUA only For in vitro diagnostic use only For prescription use onl y COVID-19 Antigen Rapid Diagnostic Test for the Detection of SARS-CoV-2 Antigen Package Insert Instructions for Use RCHM-02071.

This test has been authorized by FDA under an EUA for use by authorized laboratories and at the Point of Care by medical professionals operating under a CLIA Certificate of Waiver Certificate of Compliance or Certificate of Accreditation. Locate the extraction vial and gently peel off the aluminum foil seal being sure to keep the vial upright and place it in the packaging tray. Ad Rapid PCR Testing for Hospitals Pharmacies Urgent Cares Clinical Environments.

Our products demonstrate significant testing accuracy in the fight against COVID-19. Unpack the test components from the tray. Stand-alone test kit with no equipment needed.

As of November 22 2021 CareStart COVID-19 Antigen Home Test is authorized to use with individual anterior nasal swab specimens from individuals age 14 years and older self-collected or 2 years and older collected with adult assistance for non-prescription home use by FDA under the EUA EUA210314S002. 20 Test devices 20 Assay buffers 20 Extraction vials and caps 20 Specimen collection swabs 1 Positive and 1 negative control swabs Instructions guide ITEM CODE. To assist in reducing transmission during a pandemic fast infection testing results is a requirement.

The AccessBio CareStart COVID-19 Antigen HOME KIT. Remove the test cassette and place it on a flat clean surface. Rapid results in 10 minutes.

The PPA and NPA of our tests can be found in the IFUs. Our rapid antigen test is a must-have at the point-of-care bringing immediate actionable results when you need them. Demand for rapid test kits among the medical community is rising because unlike polymerase chain reaction PCR tests they require no special equipment.

This Fact Sheet contains information to help you understand the risks and benefits of using this test for the diagnosis of COVID-19. Simple nasal swab collection. Its suitable for use by individuals aged 12 years and above who are worried about COVID-19 for children aged between 2 and 11 the CareStart test can be conducted or.

The CareStart COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of symptom. Access Bio Inc the worlds leading manufacturer of rapid test kits for malaria developed the Carestart COVID-19 Antigen Test to rapidly detect antigens of the virus which causes COVID-19. 1 Instructions for Use The CareStart COVID-19 Antigen test has not been FDA cleared or approved.

As an intended point-of-care POC designated test with results to be read at 10 minutes CareStart COVID-19 Antigen Test allows diagnostic indication of COVID-19 by qualified healthcare professionals on a large scale. CareStart COVID-19 Antigen Disease 2019 COVID-19 You are being given this Fact Sheet because your samples was tested for the Coronavirus Disease 2019 COVID-19 using the CareStartTM COVID-19 Antigen test. Is 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.

The carestart covid-19 antigen test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from sars-cov-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of covid-19 by their healthcare provider within the first five. Step by step guide on how to self-administer the CareStart Rapid Antigen Test under the supervision of a medical or health practitioner. The CareStart Antigen Home Test utilises a short and comfortable nasal swab and is easy to use even if its your first time taking a rapid antigen test.

CONTACT US 888 965 0301 Detect COVID-19 infection in as little as 10 minutes. Rapid results within 10 minutes No lab equipment or additional instrument required. Laboratory accuracy at the point of care.

Antigen Home Test Quick Reference Instructions QRI before they use the test and the Fact Sheet for Individuals. CareStart COVID-19 Antigen Home Test. As an intended point-of-care POC designated test performed by medical professionals with a 10 minutes processing time CareStart COVID-19 Antigen Test helps provide critical answers about active infections to patients and healthcare workers alike.

Wash your hands thoroughly for at least 20 seconds before the test. Principles of the Test The CareStart COVID-19 IgMIgG test is an immunochromatographic assay for the detection and differentiation of SARS-CoV-2 IgM andor IgG antibodies in human blood specimens.


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