Product Manual

Item# 3001-3354 rev. 05/21B
KIT CONTROLS
BIBLIOGRAPHY
1. CDC. Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the
Coronavirus Disease 2019 (COVID-19) Pandemic. cdc.gov.
2. CDC. Universal Precautions For Prevention Of Transmission Of Human Immunodeficiency Virus, Hepatitis B
Virus, And Other Bloodborne Pathogens In Health-Care Settings. MMWR 1988; 37(24):377-388.
EXPLANATION OF SYMBOLS
Batch Code
Catalog Number
Manufacturer
Caution, Consult
Accompanying Documents
Temperature Limitation
Use By
Part Number
In Vitro Diagnostic
Medical Device
FOR USE UNDER EMERGENCY USE AUTHORIZATION (EUA) ONLY.
For in vitro Diagnostic Use
These Instructions for Use and the InteliSwab
TM
COVID-19 Rapid Test Pro Instructions for Use must
be read completely before using the product. Follow the instructions carefully; failure to do so
may cause an inaccurate test result. Before proceeding with testing, all operators MUST read and
become familiar with Interim Infection Prevention and Control Recommendations for Healthcare
Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic.
1
These Kit Controls do not
contain live virus and are formulated with non-infections materials.
NAME AND INTENDED USE
The InteliSwab
TM
COVID-19 Rapid Test Pro Kit Controls are intended as an external quality control reagents to monitor
the performance of the InteliSwab
TM
COVID-19 Rapid Test Pro with direct anterior nasal samples. For use only with the
InteliSwab
TM
COVID-19 Rapid Test Pro.
Run the Kit Controls under the following circumstances:
• Each new operator prior to performing testing on patient specimens,
• When opening a new test kit lot,
• Whenever a new shipment of test kits is received,
• If the temperature of the test kit storage area falls outside of 2°-30°C (35°-86°F), and
• At periodic intervals as dictated by the user facility, country, state or local regulations and policies.
It is the responsibility of each laboratory using the InteliSwab
TM
COVID-19 Rapid Test Pro to establish an adequate
quality assurance program to ensure the performance of the device under its specific locations and conditions of use.
SUMMARY AND EXPLANATION OF THE KIT CONTROLS
The InteliSwab
TM
COVID-19 Rapid Test Pro Kit Controls are formulated using a nucleocapsid recombinant antigen in a
PBS+1% BSA solution. The Kit Controls are specifically formulated and manufactured to ensure proper performance of
the test. The COVID-19 Positive Control will produce a reddish-purple line at the Test (T) Zone. The COVID-19 Negative
Control will generate a negative test result (no line at the T Zone). Both controls will produce a reddish-purple line in the
Control (C) Zone. Refer to Test Result and Interpretation of Test Result section of the InteliSwab
TM
COVID-19 Rapid Test
Pro Instructions for Use. Use of kit control reagents manufactured by any other source will not meet the requirements
for an adequate quality assurance program for the InteliSwab
TM
COVID-19 Rapid Test Pro.
220 East First Street
Bethlehem, PA 18015 USA
(800) ORASURE (1-800-672-7873) • [phone]
www.OraSure.com
For Technical or Customer Service within the United States, phone (800) ORASURE (800-672-7873).
For customers outside the United States, phone +[phone] 1820 or go to www.OraSure.com