Product Manual

Item# 3001-3357 rev. 05/21B
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.
FOR USE UNDER EMERGENCY USE AUTHORIZATION (EUA) ONLY.
For in vitro Diagnostic Use
All new operators must be able to correctly interpret all devices provided within the InteliSwab™
COVID-19 Rapid Test Pro Visual Reference Panel prior to using the InteliSwab™ COVID-19 Rapid
Test Pro.
Failure to read at low intensities can result in the inability to detect specimens near the limit of
detection of the InteliSwab™ COVID-19 Rapid Test Pro and may result in false negative results.
These Instructions for Use and the InteliSwab™ 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.
NAME AND INTENDED USE
The InteliSwab™ COVID-19 Rapid Test Pro Visual Reference Panel is intended to assist new operators in becoming
proficient at reading specimens with antigen levels near the limit of detection of the device. The InteliSwab™ COVID-19
Rapid Test Pro Visual Reference Panel is comprised of InteliSwab™ COVID-19 Rapid Test Pro devices that have been
designed to represent reading intensities of limit of detection, low positive, and negative test results. The limit of detection
test device is indicative of specimens with antigen levels at the limit of detection of the device.
It is the responsibility of each laboratory using the InteliSwab™ COVID-19 Rapid Test Pro to establish an adequate quality
assurance program to ensure proficiency of new operators in their ability to interpret test results. The clinical performance
of this device was established based on an operator’s ability to read visual intensities at the Test (T) Zone at all levels
including very weak lines representing low antigen levels.
SUMMARY AND EXPLANATION OF THE COVID-19 VISUAL REFERENCE PANEL
The InteliSwab™ COVID-19 Rapid Test Pro Visual Reference Panel consists of three devices that have been manufactured
to represent limit of detection, low positive, and negative test results. The devices are specifically formulated and
manufactured to assist new operators in becoming proficient at reading specimens with antigen levels near the limit of
detection of the device. The COVID-19 Limit of Detection Device has a very faint reddish-purple line at the Test (T) Zone.
The COVID-19 Low Positive Device has a reddish-purple line at the Test (T) Zone. The COVID-19 Negative Device does
not have a line at the Test (T) Zone. All devices have a reddish-purple line at the Control (C) Zone. Refer to Test Result
and Interpretation of Test Result section of the InteliSwab™ COVID-19 Rapid Test Pro Instructions for Use on how to
interpret the devices.
This panel is to be used to assist new operators with becoming proficient at reading and interpreting
InteliSwab™ COVID-19 Rapid Test Pro results at or near the limit of detection of the device. The
InteliSwab™ COVID-19 Rapid Test Pro
Visual Reference Panel is NOT to be used as a quality control
device to set intensity values used as a cutoff for reading and interpreting InteliSwab™ COVID-19 Rapid
Test Pro devices. Any line at the Test (T) Zone is considered a positive result regardless of how faint
the line appears.
VISUAL REFERENCE PANEL
220 East First Street
Bethlehem, PA 18015 USA
(800) ORASURE (1-800-672-7873)
[phone]
www.OraSure.com
EXPLANATION OF SYMBOLS
Batch Code
Catalog Number
Manufacturer
Caution, Consult
Accompanying Documents
Temperature Limitation
Use By
PN
Part Number
In Vitro Diagnostic
Medical Device
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