Rapid Test Kit CareStart™ Antigen Test Covid-19 Antigen Nasopharyngeal Swab Sample 20 Tests

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Product Specifications

Manufacturer # RCHM-02071
Brand CareStart™
Manufacturer Intrivo Diagnostics
Country of Origin Unknown
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
Test Method Lateral Flow Immunochromatographic Assay
Test Name Covid-19 Antigen
Test Type Antigen Test
Time to Results 10 Minute Results
UNSPSC Code 41116126
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