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Rapid COVID-19 Antigen Test
20 Test Kits

covid-19-rapid-antigen-test-kit
SKU: 843 Category: Tags: , ,
20 Point of Care Antigen Test Kits

This product has received its EUA from the FDA.

  • For use with direct anterior nasal and nasopharyngeal swab specimens
  • Detects SARS-CoV-2 nucleocapsid protein antigen
  • Rapid results within 10-15 min
  • More cost-effective than lab PCR tests, allowing you to test more often

No refunds/returns. 

Authorized for use only in-patient care settings, this product is for licensed medical professionals only.

Testing is not for home use. Orders placed without a CLIA number will not be processed.

CALL 800.228.9890 TO ORDER.

same day shipping

$ 250.00

Description

Point of Care COVID-19 Antigen Test

The CareStart point of care COVID antigen test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal and nasopharyngeal swab specimens collected from patients within 5 days of symptom onset. Test results ready in 10-15 min.

Authorized for use only in-patient care settings, this product is for licensed medical professional use only.

Clinical Performance

  • 93.75% PPAa and 99.32% NPAb when used with nasopharyngeal swab
  • 93.75% PPAa and 99.32% NPAb when used with nasopharyngeal swab
  • aPPA: Positive Percent Agreement, bNPA: Negative Percent Agreement

Manufacturer’s Statement:

  • This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories.
  • This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
  • The emergency use of this product 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Each box includes:
  • 20 testing devices
  • 20 assay buffer
  • 20 extraction vials and caps
  • 20 specimen collection swabs
  • 1 positive and 1 negative control swabs
  • Use instruction sheet
Nas0pharyngeal Swab Collection Instructions:covid-antigen-collection-instructions
  1. Remove the swab from the package.
  2. Place the swab into one of patient’s nostrils until it reaches the posterior nasopharynx; keep inserting until resistance is equivalent to that from the ear to the nostril of the patient.
  3. Slowly rotate the swab 3-5 times over the surface of the posterior nasopharynx.
  4. Slowly remove the swab from the nostril while rotating it.
Anterior Nasal Swab Collection Instructions:

  1. Remove the swab from the package
  2. Place the swab into one of patient’s nostrils until it reaches the posterior nasopharynx; keep inserting until resistance is equivalent to that from the ear to the nostril of the patient.
  3. Slowly rotate the swab 3-5 times over the surface of the posterior nasopharynx.
  4. Slowly remove the swab from the nostril while rotating it.
Test Process Instructions:

rapid-covid-antigen-instructions

  1. Peel off aluminum foil seal from the top of the extraction vial containing the extraction buffer.
  2. Place the swab into the extraction vial. Rotate the swab vigorously at least 5 times.
  3. 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.
  4. Close the vial by pushing the cap firmly onto the vial.
  5. Mix thoroughly by flicking the bottom of the tube
  6. Invert the extraction vial and hold the sample vertically above the sample well. Squeeze the vial gently. Allow 3 drops to sample to fall into the sample well.
  7. Read the result at 10 minutes. Test should not be read after 15 minutes.
  • Lateral flow assay
  • Rapid results in only 10-15 min
  • Direct anterior nasal and nasopharyngeal swab specimen collections
  • Detects SARS-CoV-2 nucleocapsid protein antigens
  • Intended for Point-of-Care setting by medical professionals
  • More cost-effective than lab PCR tests, allowing you to test more often
Clinical Performance:
  • 93.75% PPAa and 99.32% NPAb when used with nasopharyngeal swab
  • 93.75% PPAa and 99.32% NPAb when used with nasopharyngeal swab
    • aPPA: Positive Percent Agreement, bNPA: Negative Percent Agreement

COVID Antigen Product Insert and Instructions

COVID Antigen Product Spec Sheet

COVID Patient Fact Sheet

COVID Healthcare Provider Fact Sheet

FDA EUA Letter

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