CareStart™ COVID-19 Antigen​ Rapid POC Test

Access Bio’s CareStart™ COVID-19 Antigen
Rapid POC Test

EXP DATE: November 1st, 2025

Package Size: Box of 20 Tests or Case of 640 Tests.

Experience peace of mind with the CareStart™ COVID-19 Antigen Test, a cutting-edge lateral flow assay designed for rapid and reliable detection of the SARS-CoV-2 nucleocapsid protein antigen. With results available within 10-15 minutes, this test is ideal for use in point-of-care (POC) settings, ensuring quick decision-making by medical professionals.

This COVID-19 Antigen Test is exclusively available for testing at CLIA-certified laboratories by the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a. Our test is specifically authorized for use in point-of-care (POC) scenarios, such as inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, ensuring the highest quality testing standards for moderate, high, or waived complexity tests.

Key Features:

• Lateral flow assay for efficient testing
• Detects SARS-CoV-2 nucleocapsid protein antigen
• Rapid results within 10-15 minutes
• Intended for use in POC settings by certified medical professionals
• Emergency Use Authorization (EUA) compliant
• In vitro diagnostic use under prescription only
• Designed for use with direct anterior nasal or nasopharyngeal swab specimens

Contents:

• Test device (20)
• Extraction vial (20)
• Cap (20)caps
• Swabs (20)
• Positive control swab (1)
• Negative control swab (1) each
• Package insert (1)
• Instructions for use (1)
• Quick Reference Instructions (QRI) (1)

Clinical Performance:

• 93.75% Positive Percent Agreement (PPA) and 99.32% Negative Percent Agreement (NPA) with nasopharyngeal swab
• 87.18% PPA and 100% NPA with anterior nasal swab

Interpretation:

• Positive results indicate the presence of SARS-CoV-2 antigen, with color intensity reflecting the antigen amount.
• Negative results are presumptive and should be confirmed by molecular testing, especially in the presence of symptoms or contact with the virus.
• Invalid results prompt a re-run for accuracy.

Important Documents

• FACT SHEET FOR HEALTHCARE PROVIDERS
• FACT SHEET FOR PATIENTS
• IFU (INSTRUCTIONS FOR USE)
• FDA EMERGENCY USE AUTHORIZATION
• MATERIAL SAFETY DATA SHEET (MSDS)

Delivery times vary according to your selected delivery address, the availability of your items, and the time of day you place your order.

For B2B accounts, please get in touch with us at sales@pechmedical.com for urgent order requests.

Please feel free to visit our Support Page for FDA Extension Letters, Submit a Ticket, and more.

At Peach Medical Corp we use UPS (most orders ship via UPS but some may ship via USPS) as our logistic and Shipping partners. Currently, our shipping methods are as follows:

Please verify your address when ordering, we are unable to fix an incorrect shipping address on an order once it is in transit. If your order is in transit with an incorrect address, please reach out to your carrier to reroute the package. Peach Medical Corp. is not able to have packages rerouted or contact the carrier for you.

Refunds will not be issued for packages that were shipped to an incorrect address but it may be possible for a replacement package to be sent, please contact the customer service team to see if you are eligible.

The Peach Medical COVID-19 Antigen Rapid Test and all face masks are Non-returnable & Non-refundable as they are considered personal-use items. Replacement may be shipped if the item is defective. Proof of purchase, photos of defects, lot numbers, and other information are required to authorize a replacement. Please reach out to customer service for detailed requirements before disposing of the defective units. We will not replace your COVID-19 Antigen Rapid Test kits that are expiring soon based on the printed label. Our expiration dates have been shown on each product page. More information can be found at support.peachmedical.com/portal/en/kb/peachmedicalsourcing. We will continue to update the FDA documents for shelf-life extensions for our tests.

If a customer chooses a 3rd party receiver who is not the purchaser, Peach Medical is not responsible for any goods once they leave our warehouse and when tracking is provided. I.e Gifts, International Shipping Services. All Products must be packed in the original, unopened, and unmarked packaging including any accessories, manuals, documentation, and registration that shipped with the Product.

Note: If Peach Medical has not shipped your item within 7 business days, cancellations will be honored. Please email us at support@peachmedical.com for return authorization and the shipping address.