Intrivo Diagnostics #RCHM-02071 Rapid Test Kit CareStart™ Antigen Detection Covid-19 Antigen Nasal Swab Sample 20 Tests TEST, COVID-19 CARESTART ANTIGEN RAPID AN SWAB (20TEST/KT) Manufacturer # RCHM-02071 Brand CareStart™ Manufacturer Intrivo Diagnostics Country of Origin United States Application Rapid Test Kit Contents (20) Test Devices, (20) Assay Buffers, (20) Extraction Vials and Caps, (20) Specimen Collection Swabs, (1) Positive and (1) Negative Control Swab, Instructions for Use Number of Tests 20 Tests Product Dating Acceptable Dating: we will ship >= 30 days Reading Type Visual Read Sample Type Nasal Swab Sample Storage Requirements USP Controlled Room Temperature Test Format Cassette Format Test Method Lateral Flow Immunochromatographic Assay Test Name Covid-19 Antigen Test Type Antigen Detection Time to Results 10 Minute Results UNSPSC Code 41116205 Product ships from Rally with minimum 30 days dating Anterior Nares / AN Swabs This product has been authorized by the FDA under its Emergency Use Authorization Customers should review requirements, including notification of public health authorities, as they are stated here: https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices Emergency use of this test is limited to authorized 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 Positive results indicate the presence of viral antigens, but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status; Positive results do not rule out a bacterial infection or co-infection with other viruses Negative results are presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed; negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions 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 anterior nare (nasal swab) specimens either directly collected or collected in BD universal transport media from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of symptom onset Identify acute infection with 87.2% sensitivity and 100% specificity Intended at POC setting (i.e., in patient care settings) by medical professionals with a CLIA waiver. ACCESS BIO’S CARESTART™ COVID-19 Antigen RAPID POC TEST Due to the highly contagious nature and global health crisis, SARS-CoV-2 has been designated as a pandemic by the World Health Organization (WHO) and continues to have devastating impacts on healthcare systems and the world economy including the U.S. To effectively end the SARS-CoV-2 pandemic, systematic screening and detection of both clinical and asymptomatic COVID-19 cases is critical. As an intended point-of-care (POC) designated test with a 10 minute processing time, 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., in patient care settings) by medical professionals Detect SARS-CoV-2 nucleocapsid protein antigen Identify acute infection with high sensitivity and 100% specificity TEST PRINCIPLES 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. CAT. NO. RCHM-02072 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 Technical Support For questions, or to report a problem, please call Technical Support at +1-888-898-1270 (Available Hours: Mon. to Fri.: 8 a.m. – 5 p.m.) or [email protected] (24/7 available). Warnings and Precautions For prescription and in vitro diagnostic use only. This test has not been FDA cleared or approved. This test has not been FDA cleared or approved; the test 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 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. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician. Immediately use after opening the test device in the pouch. In order to obtain accurate results, the test must follow this package insert. Excess blood or mucus on the swab specimen may interfere with test performance and may yield a false-positive result. Avoid touching any bleeding areas of the nasopharynx when collecting specimens. Do not interpret the test result before 10 minutes and after 15 minutes starting the test. Inadequate or inappropriate sample collection, storage, and transport can result in incorrect results.If specimen storage is necessary, swabs can be placed into extraction buffer for up to four hours. Specimens should not be stored dry. Do not use if the test device package is damaged. Do not use the kit contents beyond the expiration date. Do not eat, drink, or smoke in the area where the specimens and kit contents are handled. Use appropriate precautions in the collection, handling, storage, and disposal of patient samples and used kit contents. Dispose of used contents as biohazardous wastes in accordance with federal, state, and local requirements. Nitrile or latex gloves should be worn when performing this test. If the extraction buffer contacts the skin or eye, flush with copious amounts of water. Handle all specimens as though they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens. Reagents contain sodium azide, which is harmful if inhaled, swallowed, or exposed to skin. Contact with acids produces a very toxic gas. If there is contact with skin, wash immediately with plenty of water. Sodium azide may react with lead and copper plumbing to form highly explosive metal azides. On disposal, flush with a large volume of water to prevent azide build-up. Do not interchange kit contents from different lots. Do not re-use any contents in the kit as they are single-use only. For additional information on hazard symbols, safety, handling and disposal of the components within this kit, please refer to the Safety Data Sheet (SDS) located at accessbio.net Storage and Stability • Store the test kit as packaged between 1 ~ 30°C. • The reagents and materials in the CareStart™ COVID-19 Antigen are stable until the expiration date printed on the outer packaging. Do not use beyond the expiration date. • The test device must remain in the sealed pouch until use. • Do not freeze any contents of the kit. Quality Control Internal Quality Control: The CareStart™ COVID-19 Antigen contains a built-in internal procedural control that is included in the test device. A red-colored line appearing in the control region “C” is designed as an internal procedural control. The appearance of the procedural control line indicates that sufficient flow has occurred, and the functional integrity of the test device has been maintained. If the procedural control line does not develop in 10 minutes, the test result is considered invalid and retesting with a new device is recommended. If the internal procedural control line is still absent in the retest, please contact the Technical Support at +1- 888-898-1270 (Available Hours: Mon. to Fri.: 8 a.m. – 5 p.m.) or [email protected] (24/7 available). External Control: External control is used to demonstrate that the test device and test procedure perform properly. It is recommended that positive and negative external control swabs are run once with every new lot, shipment, and each new user. External positive and negative control swabs are provided in the kit. The external control should be tested using the nasopharyngeal swab test procedure provided in this package insert or the quick reference instruction card. If the external control results are invalid, please contact the Technical Support at +1-888-898-1270 (Available Hours: Mon. to Fri.: 8 a.m. – 5 p.m.) or [email protected] (24/7 available) before testing patient specimens.
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