Kit Rapid Test cassett COVID-19 (SARS-coV-2) Antigen lateral flow Swab 10 minute CareStart ™ ITEM # RCHM-02071 (Emergency Use Authorization) by AccessBio, Inc. ID RCHM-02071

188-1-2072
      
Stock Est. Shipping Date: 17th April 2025 ⓘ

Kit Rapid Test cassett COVID-19 (SARS-coV-2) Antigen lateral flow Swab 10 minute CareStart ™ ITEM # RCHM-02071 (Emergency Use Authorization)
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Rally #188-1-2072
Access Bio #RCHM-02071
CareStart™ COVID-19 Antigen Test (20 Test / Kit)

Respiratory Test Kit, SARS-COV-2, Lateral Flow Immunochromatographic Assay, Nasopharyngeal / Anterior Nasal Swab, Rx Only

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Save On Flu A&B, RSV, COVID-19 or COVID-19/Flu A&B Combo Test Kits

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See Details Below
Features
  • Rapid results within 10-15 minutes
  • Stand-alone test kit with no equipment needed
  • Room temperature storage
The CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

The CareStart™ COVID-19 Antigen test does not differentiate between SARS-CoV and SARS-CoV-2.

Negative results are presumptive. Negative test results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions.

The COVID-19 Antigen test is intended for use by medical professionals or operators who are proficient in performing tests in point of care settings.

Important Note:
  • Restricted Product: Rx Only - Current Valid Medical License Required.
  • If put into refrigeration, do not freeze.
  • For in vitro diagnostic use.
  • For use under an Emergency Use Authorization (EUA) only.
  • For more information on this product's EUA, please go to the EUA section below.
For the State of California:
Warning: This product can expose you to chemicals known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.

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Rally #188-1-2072
Manufacturer #RCHM-02071
BrandCareStart™
ManufacturerAccess Bio
Country of OriginUnknown
ApplicationRespiratory Test Kit
Number of Tests20 Tests
Reading TypeVisual Read
Sample TypeDirect Anterior Nasal Or Nasopharyngeal Swab
SpecialtyImmunoassay
Test FormatCassette Format
Test Kit TypeRapid
Test MethodLateral Flow Chromatographic Immunoassay
Test NameCovid-19 Antigen
Test TypeAntigen Detection
Time to Results10-15 Minutes
UNSPSC Code41116205
Storage Temperature1–30°C
Type PPA NPA
Nasopharyngeal Swab 93.75% 99.32%
Anterior Nasal Swab 87.18% 100%

PPA : Positive Percent Agreement
NPA : Negative Percent Agreement


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Currently Unavailable

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Reagents and Materials Provided - RCHM-02071 (For 1 Kit)
Contents Name Quantity Description
Test device 20 each Foil pouched test device containing one test strip which is encased in plastic device cassette.
Extraction vial / cap 20 vials and caps The extraction vial contains extraction buffer solution.
Nasal (or nasopharyngeal) swab 20 each Swabs for specimen collection.
Positive control swab 1 each Recombinant SARS-CoV-2 nucleocapsid protein antigen is dried on the foam-tipped head.
Negative control swab 1 each Blank swab
Package insert 1 each Instructions for use
Quick Reference Instructions (QRI) 1 each Quick reference instructions
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Save On Flu A&B, RSV, COVID-19 or COVID-19/Flu A&B Combo Test Kits

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Offer Valid Through December 31, 2025 Only



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Emergency Use Authorization (EUA)

  • In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization. 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. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
  • This product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the CLIA that meet the requirements to perform moderate, high or waived complexity tests. This product 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.
For additional EUA information on the product, please see the IFU and FDA EUA in the Education & Documents sections.


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