Access Bio CareStart™ COVID-19 Rapid Antigen Test

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SKU:
RCHM-02071
$520.00
Quantity Price per Box (20) Each Price
Buy 1 - 1 $520.00 $26.00
Buy 2 or above $515.00 $25.75

Description

Access Bio CareStart COVID-19 Rapid POC Antigen Test, 20 Kits/Box

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RAPID POC TEST

PRODUCT MANUFACTURED WITH 6 MONTH EXPIRATION DATE

Due to the highly contagious nature and global health crisis, SARS-CoV-2 has been designated as a pandemic by the World Health Organization (WHO) and continues to have devastating impacts on healthcare systems and the world economy including the U.S. To effectively end the SARS-CoV-2 pandemic, systematic screening and detection of both clinical and asymptomatic COVID-19 cases is critical.

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 on a large scale.

TEST FEATURES

  • Lateral flow assay
  • Rapid results in 10 minutes
  • Nasopharyngeal swab specimen collection
  • Intended at POC setting (i.e., in patient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
  • Detect SARS-CoV-2 nucleocapsid protein antigen
  • Identify acute infection in symptomatic patients with 88.4% sensitivity and 100% specificity
  • Designated as a CLIA waived tests

TEST PRINCIPLES

The 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 swab specimens directly collected from symptomatic individuals who are suspected of COVID-19 by their healthcare providers.

TEST PROCEDURE

1 Peel off aluminum foil seal and rotate the swab inside the extraction vial vigorously at least 5 times. 2 Remove the swab by rotating against the extraction vial while squeezing the sides of the vial to release the liquid from the swab. Properly discard the swab. 3 Close the vial by pushing the cap firmly onto the vial and mix thoroughly by flicking the bottom of the tube. 4 Invert the extraction vial and hold the sample vertically above the sample well. Squeeze the vial gently. Allow three (3) drops of sample to fall into the sample well.
CareStart Procedure - 1 CareStart Procedure - 2 CareStart Procedure - 3 CareStart Procedure - 4

RESULTS INTERPRETATION

Covid-19 Positive Covid-19 Negative Invalid

 CareStart Covid19 Antigen Results - Positive

CareStart Covid19 Antigen Results - Negative

CareStart Covid19 Antigen Results - Invalid

PRODUCT DOCUMENTATION

Fact Sheet for Healthcare Providers

IFU Instructions For Use

Fact Sheet for Patients

FDA Emergency Use Authorization

ORDERING INFORMATION

KIT COMPONENTS:

  • 20 Test devices
  • 20 Assay buffer
  • 20 Extraction vials and caps
  • 20 Specimen collection swabs
  • 1 Positive and 1 negative
  • 1 Instructions for Use

CAT NUMBER: RCHM-02071

PACKAGING: 20 TESTS/KIT

Extra Information

Brand:
Access Bio