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Antigen COVID-19 rapid POC Test As an intended point-of-care (POC) designated test with a 10 minute processing time

Antigen COVID-19 rapid POC Test As an intended point-of-care (POC) designated test with a 10 minute processing time

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Item#: Int-RCHM-02071-KT
15+
$479.00$464.00
Item(s) Total: $479.00
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
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Price shown is sold as per Kit

  • Product Details
    • Dealer # 1181709
    Manufacturer # RCHM-02071
    Brand CareStart™
    Manufacturer Intrivo Diagnostics
    Application Rapid Test Kit
    Contents (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 20 Tests
    Reading Type Visual Read
    Sample Type Nasopharyngeal Swab Sample
    Storage Requirements USP Controlled Room Temperature
    Test Format Cassette Format
    Test Method Lateral Flow Immunochromatographic Assay
    Test Name Covid-19 Antigen
    Test Type Antigen Test
    Time to Results 10 Minute Results

    Features

    • 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
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