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Carestart Rapid Antigen COVID-19 POC 20-Pack Tests
per package (20 tests per package)
Are you symptomatic and in need of an ultra-fast COVID-19 test? Instead of waiting days for an answer like some RT-PCR based tests, the Carestart COVID-19 Antigen Test for nasal swabs can yield results in just 15-30 minutes and could be perfect for you. Currently, available test kits will expire as early as June 30, 2022.
The continuing spread of COVID-19 worldwide has raised the importance of rapid screening for testing in a clinical context. Demand for rapid test kits among the medical community is rising because unlike polymerase chain reaction (PCR) tests, they require no special equipment. Access Bio, Inc., the world’s leading manufacturer of rapid test kits for malaria, developed the Carestart COVID-19 Antigen Test to rapidly detect antigens of the virus which causes COVID-19.
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 suspected of COVID-19 by their healthcare provider within five days of symptom onset. Testing with the Carestart COVID-19 Antigen Test 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., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
- FAST: Results within 10 mins
- ACCURATE: Sensitivity: 88.4% and specificity: 100%
- EASY TO USE: All necessary reagents provided & no equipment needed
- EASY STORAGE: Storage temperature: 34-86℉/1-30℃
- 20 Tests per Box
- Package Insert
- Quick Reference Instructions
- Instructions for Use
- FDA Emergency Use Authorization Letter
- FDA Expiration Extension 3.15.2021
- Fact Sheet for Healthcare Providers
- Fact Sheet for Patients
- 20 Test Devices
- 20 Assay Buffers
- 20 Extraction Vials and Caps
- 20 Specimen Collection Swabs
- 1 Positive and 1 Negative
- 1 Instruction Flyer for Use
- Online Training
Notices from AccessBio:
- 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.
- This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
- This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories;
- Sales of tests are limited only to those with a CLIA Certificate of Waiver or to licensed resellers. We do not promote the use of this product for anything other than Points-of-Care (POC) settings. The tests are only authorized at this time for POC use by qualified healthcare professionals for a diagnostic indication.
Feel free to contact us any time with questions at email@example.com, and we’d be happy to help you out!
Want to learn more about picking the perfect COVID-19 test for your situation? Check out our blog on this topic here.
- Turnaround Time: 30 minutes
- Specificity: 87%
- Sensitivity: 98%
- Limit of Detection: 2.8×103 TCID50/ml
Important Collection Notes:
- Process the test sample immediately after collection.
- Use only provided or recommended anterior nasal swab for specimen collection.
- Collect the specimen wearing safety gloves to avoid contamination
- Do not touch the tip (specimen collection area) of the swab.
- Collect samples as soon as possible within 5 days of symptom onset.
- Here are some simplified instructions from Meenta regarding how to use this Carestart COVID-19 Antigen Test
- The CDC also had some very useful instructions for nasal swab collections here.
- Credit Card
- HSA Card
- PO Number
Note: These products and services are not returnable. Check your kit expiration date upon receipt. Using expired test kits is not recommended because they may provide inaccurate results.