Contact Our Customer Service Team
We’re here to assist with selection, ordering, and more.
We take care of your privacy. By clicking submit, you consent to allow Intrivo to store and process the personal information submitted to provide you the content requested. More Info
Helping You Reconnect
WE’RE HERE TO ASSIST WITH ANY QUESTIONS ABOUT OUR SERVICES.
We take care of your privacy. By clicking submit, you consent to allow Intrivo to store and process the personal information submitted to provide you the content requested. More Info
We take care of your privacy. By clicking submit, you consent to allow Intrivo to store and process the personal information submitted to provide you the content requested. More Info
About Intrivo
Your healthiest life starts here!
As a digital health company, our mission is to help people live happier, healthier and longer lives by providing them with intuitive tools and comprehensive health information to steward them across their entire health journey.
- Back to work, safely!
Tools for organizations that keep people safe, enquire about testing kits for your business, inquire about testing kits for your business. - Confidence to reconnect!
Rejoin the world and the things you miss most: concerts, dinners, hugs and handshakes.
- Your Health in Your Hands!
Accurate, timely and accessible health information at your fingertips. Sign up to be notified first when the Intrivo app is live!
About Intrivo
Your healthiest life starts here!
As a digital health company, our mission is to help people live happier, healthier and longer lives by providing them with intuitive tools and comprehensive health information to steward them across their entire health journey.
- Back to work, safely!
Tools for Organizations that keep people safe, inquire about testing kits for your business. - Confidence to reconnect!
Rejoin the world and the things you miss most, concerts, dinners, hugs and handshakes. - Your Health in Your Hands!
Accurate, timely and accessible health information at your fingertips. Sign up to be notified first when the intrivo app is live!
KIT COMPONENTS
- 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
DOCUMENTATION
Note: For Serial Screening of asymptomatic individuals. The serial screening indication is only applied to products manufactured by Access Bio Inc. after April 12, 2021. The product batches listed in the Official Notification Letter should not be marketed or used for POC serial screening purposes.
HIGHLIGHTED PRODUCT
CareStart™ Covid-19 Antigen (POC)
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.
Intrivo is the exclusive US commercialization partner of Access Bio
- Lateral flow assay
- Detect SARS-CoV-2 nucleocapsid protein antigen
- Rapid results within 10-15 minutes
- Intended at POC setting (i.e., in patient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
- For use under the Emergency Use Authorization (EUA) only
- For in vitro diagnostic use only
- For prescription use only
- For use with direct anterior nasal and nasopharyngeal swab specimens
HIGHLIGHTED PRODUCT
CareStart™ Covid-19 Antigen (POC)
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.
- Lateral flow assay
- Detect SARS-CoV-2 nucleocapsid protein antigen
- Rapid results within 10-15 minutes
- Intended at POC setting (i.e. in patient care settings) by medical professionals operating under CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
- For use under the Emergency Use Authorization (EUA) only
- For in vitro diagnostic use only
- For prescription use only
- For use with direct anterior nasal and nasopharyngeal swab specimens
- NOTE: For Serial Screening of asymptomatic individuals. The serial screening indication is only applied to products manufactured by Access Bio, Inc. after April 12, 2021. The product batches listed in the Official Notification Letter should not be marketed or used for POC screening purposes.
KIT COMPONENTS
- 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
Clients and Industries We Serve
Providers
We provide physicians, providers, and health care systems with diagnostics solutions that help you treat individuals with compassion and certainty, safeguard your community, and enhance the bottom line.
Health & Government Officials
Our goal is to be your partner in public health. With an advisory board that includes physicians who have served the CDC, WHO, and NIC, we ensure alignment between our offerings and large public health initiatives.
Payers
Intrivo’s high-quality test offerings deliver the most accurate results, which increases credibility for health care systems and helps payers achieve greater care efficiency and address health needs at the population level.
STAY UP TO DATE
Intrivo News
Antigen vs. PCR Comparison
Antigen vs. PCR Comparison https://intrivo.com/wp-content/uploads/2021/05/Woman-Self-Testing-1024x683-1.jpg 1024 683 INTRIVO https://intrivo.com/wp-content/uploads/2021/05/Woman-Self-Testing-1024x683-1.jpg
Rapid Antigen Testing in COVID-19 Population Management
Rapid Antigen Testing in COVID-19 Population Management https://intrivo.com/wp-content/uploads/2021/03/GettyImages-1213710695-copy.jpg 1480 1049 INTRIVO https://intrivo.com/wp-content/uploads/2021/03/GettyImages-1213710695-copy.jpg
Brief: Monitoring Variant Strains and our Test
Brief: Monitoring Variant Strains and our Test https://intrivo.com/wp-content/uploads/2021/03/virus.jpg 1529 1049 INTRIVO https://intrivo.com/wp-content/uploads/2021/03/virus.jpg
Intrivo Teams with Amazon Business to Offer COVID-19 Rapid Test
Intrivo Teams with Amazon Business to Offer COVID-19 Rapid Test https://intrivo.com/wp-content/uploads/2021/03/GettyImages-520705224-3-scaled.jpg 2560 1708 INTRIVO https://intrivo.com/wp-content/uploads/2021/03/GettyImages-520705224-3-scaled.jpg
Intrivo Secures Agreement with McKesson Medical-Surgical
Intrivo Secures Agreement with McKesson Medical-Surgical https://intrivo.com/wp-content/uploads/2020/12/agreement-mcKesson.jpg 1529 1049 INTRIVO https://intrivo.com/wp-content/uploads/2020/12/agreement-mcKesson.jpg
Intrivo Inks deal with Concordance Healthcare and NDC Inc.
Intrivo Inks deal with Concordance Healthcare and NDC Inc. https://intrivo.com/wp-content/uploads/2020/12/deal-concordance-healthcare.jpg 1529 1049 INTRIVO https://intrivo.com/wp-content/uploads/2020/12/deal-concordance-healthcare.jpg
FDA Greenlights Access Bio’s 10-Minute COVID-19 Antigen Test
FDA Greenlights Access Bio’s 10-Minute COVID-19 Antigen Test https://intrivo.com/wp-content/uploads/2020/10/fda-antigen.jpg 1529 1049 INTRIVO https://intrivo.com/wp-content/uploads/2020/10/fda-antigen.jpg
Bloomberg: Intrivo CEO on CareStart™ EUA approvals
Bloomberg: Intrivo CEO on CareStart™ EUA approvals https://intrivo.com/wp-content/uploads/2020/08/CEO-EUA-approvals-play.jpg 1529 1049 INTRIVO https://intrivo.com/wp-content/uploads/2020/08/CEO-EUA-approvals-play.jpg
Carestart™ IGM/IGG Antibody Test Granted EUA Authorization
Carestart™ IGM/IGG Antibody Test Granted EUA Authorization https://intrivo.com/wp-content/uploads/2020/08/antibody-test-receives-EUA.jpg 1529 1049 INTRIVO https://intrivo.com/wp-content/uploads/2020/08/antibody-test-receives-EUA.jpgContact Us
Define. Discover. Partner.
We are always seeking to collaborate with forward-thinking individuals, organizations, manufacturers, and institutions.
We take care of your privacy. By clicking submit, you consent to allow Intrivo to store and process the personal information submitted to provide you the content requested. More Info
The CareStart™ COVID-19 Antigen test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories and at the Point of Care by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This test has been authorized only to detect the presence of the SARS-CoV-2 nucleocapsid protein antigen, not for any other viruses or pathogens; 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 COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.