COVID-19 Rapid POC Antigen Test, Box of 20
Phoenix Healthcare Advisors, LLC is ready for immediate shipment of the CareStart COVID-19 Antigen Rapid Point of Care test kits.
- Get results in ten minutes.
- For use by healthcare professionals in point-of-care settings.
- Very affordable.
- No separate analyzer equipment is needed.Sample
- Authorized by the FDA for emergency use.
As an intended point-of-care (POC) designated test with a 10-minute processing time, the CareStart™ COVID-19 Antigen Test allows effective screening of COVID-19 infection on a large scale.
- Lateral flow assay
- Rapid results in 10 minutes
- Minimally invasive specimen collection (nasopharyngeal)
- Intended at POC setting (i.e., inpatient care settings) by medical professionals
- Detect SARS-CoV-2 nucleocapsid protein antigen
- Identify acute infection with high sensitivity and 100% specificity
The CareStartTM 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 swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider within days of symptom onset.
Phoenix Healthcare Advisors, LLC has available for immediate shipment the CareStart COVID-19 Antigen Rapid Point of Care test kits. Get results in ten minutes. For use by healthcare professionals in point-of-care settings. Very affordable. No separate analyzer equipment needed. Authorized by the FDA for emergency use.
Provide an important service to your patients, essential workers, government agencies, educators pharmacy and others who need information relating to their exposure to or infection of COVID-19.
With the second wave of COVID-19 infections underway, the demand for testing solutions has never been higher. TheCareStart test test kit from Phoenix Healthcare Advisors, LLC can be an important part of providing this service to your community.
COVID-19 Antigen Rapid Tests
|Test||CareStart Antigen||Becton Dickison (BD)||Quidel|
|Technique||Lateral flow chromatographic immunoassay||Lateral flow chromatographic immunoassay||Lateral flow chromatographic immunofluorescent|
|Instrument||No||Veritor Plus Analyzer ($400)||Sofia 2 Analyzer ($2500)|
|Preparation Time||None||None||yes (Sofia Calibration)|
|Known Cross Reactivity||No||No||SARS-CoV-1|
|Processing Time||10 minutes||15 minutes||15 minutes|
|Specimen Type||Nasopharygeal and Nasal swabs||Nasal swabs||Nasopharygeal and Nasal swabs|
|Analytical Sensitivity||8×102 TCID50/ML||1.4×102 TCID50/ML||3.4×102 TCID50/ML|
|Target||Nucleocapsid antigen||Nucleocapsid antigen||Nucleocapsid antigen|
Quick Reference Instructions for CareStart™ COVID-19 Antigen
For Emergency Use Authorization (EUA) Only
The CareStartTM COVID-19 Antigen test is a lateral ow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swab specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider within ve days of symptom onset.
- Refer to the Package Insert for Warnings and Precautions, Specimen Collection Procedures, Storage and Handling Conditions, and Quality Control Recommendations.
- Warning and Precautions – All kit components can be discarded as Biohazard waste according to local guidelines. Refer to the product safety data sheet for risk and safety phrases and disposal information.
- Biotin Interference: False negative results may occur in patients who have indicated or whose clinical status or history would indicate they are currently taking high doses of biotin (> 10 mg per day). Biotin levels of 2.5 μg/mL have been demonstrated to result in false negative test results.
- The extracted sample must be used within 4 hours of preparation when stored at room temperature.
- Refer to the CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19)
SPECIMEN COLLECTION AND HANDLING
1 Remove a nasopharyngeal swab from the pouch.
2 Place the swab into one of patient’snostrils until it reaches the posterior nasopharynx; keep insert untilresistance is equivalent to that fromthe ear to the nostril of the patient.
3 Slowly rotate 3-5 times the swab over the surface of the posterior nasopharynx
4 Slowly remove the swab from the nostril while rotating it.
In the USA, this test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by authorized laboratories; use by laboratories certied under the CLIA, 42 U.S.C. §263a, that meet 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 Certicate of Waiver, Certicate of Compliance, or Certicate of Accreditation. This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any otherviruses or pathogens. In the USA, – this test 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 the virus that causes COVID-19 under Section 564(b)(1) of theFederal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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 individuals who are suspected of COVID-19 by their healthcare providers.
Peel off aluminum foil seal and rotate the swab inside the extraction vial vigorously at least 5 times
Remove the swab by rotatingagainst the extraction vial while squeezing the sides of the vial to release the liquid from the swab. Properly discard the swab.
Close the vial by pushing the cap firmly onto the vial and mix thoroughly by flicking the bottom of the tube.
Invert the extraction vial andhold the sample vertically above the sample well. Squeeze the vial gently. Allow three (3) drops of sample to fall into the sample well.
Read the result at 10 minutes. The test result should not be read after 15 minutes.
SARS-CoV-2 antigen present does not rule out co-infection with other pathogens. The color intensity in the test region will vary depending on the amount of SARS-CoV-2 antigen present in the sample. Any faint colored line(s) in the test region(s) should be considered as positive.
Negative test results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions, including infection control decisions.It is recommended that these results be conrmed by a molecular testing method, if necessary for patientmanagement.
Re-run the test one time using the remaining specimen in the extraction vial if an invalid result is obtained during initial testing.
|Package Unit||20 tests/kit|
|Kit Component||20 Test devices
20 Assay buffer
20 Extraction vials and caps
20 Specimen collection swabs
1 Positive and 1 negative control swabs
1 Instructions for Use
FACT SHEET FOR HEALTHCARE PROVIDERS
CareStart™ COVID-19 Antigen
This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the CareStart™ COVID-19 Antigen test.The CareStart™ COVID-19 Antigen test is authorized for use using nasopharyngeal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
What are the symptoms of COVID-19?
Many patients with COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, dyspnea), although some individuals experience only mild symptoms or no symptoms at all. The current information available to characterize the spectrum of clinical illness associated with COVID-19 suggests that, when present, symptoms include cough, shortness of breath or dyspnea, fever, chills, myalgias, headache, sore throat, new loss of taste or smell, nausea or vomiting or diarrhea. Signs and symptoms may appear any time from 2 to 14 days after exposure to the virus, and the median time to symptom onset is approximately 5 days. For further information on the symptoms of COVID -19 please see the link provided in “Where can I go for updates and more information?” section.
Public health officials have identified cases of COVID-19 infection throughout the world, including the United States. Please check the CDC COVID-19 webpage (see link provided in “Where can I go for updates and more information?” section at the end of this document) or your local jurisdictions website for the most up to date information.
What do I need to know about COVID-19 testing?
Current information on COVID-19 for healthcare providers is available at CDC’s webpage, Information for Healthcare Professionals(see links provided in “Where can I go for updates and more information?” section).
This test is to be performed only using nasopharyngeal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.
- The CareStart™ COVID-19 Antigen test can beused to test nasopharyngeal swab specimensdirectly collected or collected in BD universaltransport media
- The CareStart™ COVID-19 Antigen test should beordered for the detection of COVID-19 in individualswho are suspected of COVID-19 by their healthcareprovider and who are within the first five days ofonset of symptoms.
- The CareStart™ COVID-19 Antigen test isauthorized for use in laboratories certified under theClinical Laboratory Improvement Amendments of1988 (CLIA), 42 U.S.C. §263a, that meetrequirements to perform high, moderate or waivedcomplexity tests.
- The CareStart™ COVID-19 Antigen test isauthorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIACertificate of Waiver, Certificate of Compliance, orCertificate of Accreditation.
Specimens should be collected with appropriate infection control precautions. Current guidance is available at the CDC’s website (see links provided in “Where can I go for updates and more information?” section).
When collecting and handling specimens from individuals suspected of being infected with COVID-19, appropriate personal protective equipment should be used as outlined in the CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). For additional information, refer to CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19) (see links provided in “Where can I go for updates and more information?” section).
What does it mean if the specimen tests positive for the virus that causes COVID-19?
A positive test result for COVID-19 indicates that antigens from SARS-CoV-2 was detected, and therefore the patient is infected with the virus and presumed to be contagious. Laboratory test results should always be considered in the context of clinical observations andepidemiological data (such as local prevalence rates and current outbreak/epicenter locations) in making a final diagnosis and patient management decisions. Patient management should be made by a healthcare provider and follow current CDC guidelines.
The CareStart™ COVID-19 Antigen test has been designed to minimize the likelihood of false positive test results. In the event of a false positive result, risks to patients could include the following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 patients, limits in the ability to work, delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of a treatment or therapy, or other unintended adverse effects.
All laboratories using this test must follow the standard testing and reporting guidelines according to their appropriate public health authorities.
What does it mean if the specimen tests negative for the virus that causes COVID-19?
A negative test result for this test means that SARS-CoV-2 antigens were not present in the specimen above the limit of detection. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Antigen tests are known to be less sensitive than molecular tests that detect viral nucleic acids. The amount of antigen in a sample may decrease as the duration of illness increases. Specimens collected after day 5 of illness may be more likely to be negative compared to a RT-PCR assay.Therefore, negative results are presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed.It is possible to test a person too early or too late during COVID-19 infection to make an accurate diagnosis via the CareStart™ COVID-19 Antigen test.
When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient’s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. The possibility of a false negative result should especially be considered if the patient’s recent exposures or clinical presentation indicate that COVID-19 is likely, and diagnostic tests for other causes of illness (e.g., other respiratory illness) are negative. If COVID-19 is still suspected based on exposure history together with other clinical findings, re-testing or testing with molecular methods should be considered by healthcare providers in consultation with public health authorities. Additional testing may be helpful to ensure testing was not conducted too early.
Risks to a patient of a false negative test result include: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events.
A negative antigen test should not be the sole basis used to determine if a patient can end isolation precautions. For additional recommendations regarding infection control, refer to CDC’s Discontinuation of Isolation for Persons with COVID-19 Not in Healthcare Settings (Interim Guidance)(see links provided in “Where can I go for updates and more information” section).
What is an EUA?
The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19.
An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in diagnosing COVID-19.
The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used).
What are the approved available alternatives?
There are no approved available alternative tests. FDA has issued EUAs for other tests that can be found at:
Where can I go for updates and more information?
- Healthcare Professionalswww.cdc.gov/coronavirus/2019-nCoV/guidance-hcp.html
- Information for Laboratorieswww.cdc.gov/coronavirus/2019-nCoV/guidance-laboratories.html
- Laboratory Biosafetywww.cdc.gov/coronavirus/2019-nCoV/lab-biosafety-guidelines.html
- Isolation Precautions in Healthcare Settingswww.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html
- Specimen Collectionwww.cdc.gov/coronavirus/2019-nCoV/guidelines-clinical-specimens.html
- Infection Controlwww.cdc.gov/coronavirus/2019-ncov/infection-control/index.html
- Discontinuation of Isolationwww.cdc.gov/coronavirus/2019-ncov/hcp/disposition-in-home-patients.html
- EUAs (includes links to patient fact sheet and manufacturer’s instructions)www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas
Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500 (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088
October 8, 2020
San Joon Han
Associate Principal Scientist / R&D Division
Access Bio, Inc.
65 Clyde Road Suite A
Somerset, NJ 08873
|Device:||CareStart COVID-19 Antigen test|
|Company:||Access Bio, Inc.|
Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swab specimens directly collected, or collected in BD universal transport media, from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset.
Emergency use of this test is limited to authorized laboratories.
|Authorized Laboratories:||Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate 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.|
Dear San Joon Han:
This letter is i n response to your1 request that the Food and Drug Administration (FDA) issuean Emergency Use Authorization (EUA) for emergency use of your product,2 pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).
On February 4, 2020, pursuant to Section 564(b)(1)(C) of the A ct, the Secretary o f the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. Pursuant to S ection 564 of the Act, and on the basis of such determination, the Secretary of HHS then declared that circumstances exist justifying t he authorization of emergency use of in _____________________
- For ease of reference, this letter will use the term “you” and related terms to refer to Access Bio, Inc..
- For ease of reference, this letter will use the term “your product” to refer to the CareStart COVID-19 Antigen testused for the indication identified above.
Please provide the following information in the form: