Antigen COVID-19 rapid POC Test As an intended point-of-care (POC) designated test with a 10 minute processing time
We only sell to businesses, clinics, government facilities, individuals may contact us by email - firstname.lastname@example.org
Antigen COVID-19 rapid POC Test As an intended point-of-care (POC) designated test with a 10 minute processing time, CareStart COVID-19 Antigen Test allows effective screening of COVID-19 infection in symptomatic patients - ━ Detect SARS-CoV-2 nucleocapsid protein antigen ━ Identify acute infection with 88.4% sensitivity and 100% specificity ━ Storage condition : 1-30 degrees celsius
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. This test has been authorized only to detect the presence of the SARS-CoV-2 nucleocapsid protein antigen,, not for any other viruses or pathogens; this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. FDA
Price shown is sold as per Kit
Rapid Test Kit
(20) Test Devices, (20) Assay Buffers, (20) Extraction Vials and Caps, (20) Specimen Collection Swabs, (1) Positive and (1) Negative Control Swab, Instructions for Use
Number of Tests
Nasopharyngeal Swab Sample
USP Controlled Room Temperature
Lateral Flow Immunochromatographic Assay
Time to Results
10 Minute Results
This product has been authorized by the FDA under its Emergency Use Authorization
Customers should review requirements, including notification of public health authorities, as they are stated here: https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices
Customers should review the Instructions For Use found here: https://www.fda.gov/media/142919/download
Customers should review the Fact Sheet for Providers found here: https://www.fda.gov/media/142917/download
Customers should make available to patients the Fact Sheet for Recipients found here: https://www.fda.gov/media/142918/download
Emergency use of this test is limited to authorized laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate 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
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
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
CareStart™ COVID-19 Antigen test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal swab specimens either directly collected or collected in BD universal transport media from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of symptom onset
Identify acute infection with 88.4% sensitivity and 100% specificity
Intended at POC setting (i.e., in patient care settings) by medical professionals with a CLIA waiver
The BEST WAY to contact is by EMAIL - Use our "Contact Us" page, if you need immediate response, write URGENT on the subject line.
Emails are monitored 9 am - 4 pm, Mon-Fri, except Holidays, California Time.
Can't find the Exact Size? Contact us ( use "contact us" page) and we will get you the info.
Need it Yesterday? we have options for 2-3 days, 4-5 days use the check out page shipping options. Take note: the clock begins the day after the order and excludes week-ends and Holidays.
Can't Find the Exact Item but you found the Manufacturer? Send us the Info, and we will locate it for you.
Need a Quote? Please email us, be accurate with part#, description and quantities.
Overseas Customers? Contact us first before making your purchase.