Product Manual

MATERIALS REQUIRED AND PROVIDED in the InteliSwab™ COVID-19 Rapid Test Pro Visual
Reference Panel
• Foil Pouch containing three predetermined InteliSwab™ COVID-19 Rapid Test Pro devices representing limit of detection, low
positive and negative test results as described below.
1. COVID-19 Limit of Detection Device
One InteliSwab™ COVID-19 Rapid Test Pro device that has been manufactured at a predetermined reactivity
level to produce a positive test result consistent with the limit of detection of the device.
2. COVID-19 Low Positive Device
One InteliSwab™ COVID-19 Rapid Test Pro device that has been manufactured at a predetermined reactivity
level to produce a positive test result.
3. COVID-19 Negative Device
One InteliSwab™ COVID-19 Rapid Test Pro device that has been manufactured to produce a negative test result.
• Instructions for Use
MATERIALS REQUIRED BUT NOT PROVIDED
• Latex, vinyl, or nitrile disposable gloves
WARNINGS
For in vitro Diagnostic Use
• These Instructions for Use must be read completely before using the product.
• Adequate lighting is required for reading and interpreting the InteliSwab™ COVID-19 Rapid Test Pro
Visual Reference Panel and the InteliSwab™ COVID-19 Rapid Test Pro.
• Follow the Test Result and Interpretation of Test Result section of the InteliSwab™ COVID-19 Rapid
Test Pro Instructions for Use for instructions on how to interpret the devices.
• The InteliSwab™ COVID-19 Rapid Test Pro Visual Reference Panel when stored protected from light
(either pouched or unpouched) is stable through the expiration date printed on the pouch.
If not protected from light or stored above indicated temperature, the unpouched device should be
discarded after 15 days.
• 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 to be a positive result regardless of
how faint the line appears.
• All testing MUST be conducted under appropriate biosafety conditions in accordance with CDC
guidelines.
1
All study personnel conducting testing MUST read and be familiar with Universal
Precautions.
2
• This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for
use by laboratories certified under CLIA that meet requirements to perform moderate, high or
waived complexity tests. This product 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 product has been authorized only for the detection of proteins from SARS-CoV-2, not for
any other viruses or pathogens.
• The emergency use of this product 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 Federal Food Drug and Cosmetic Act, 21
U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or the authorization is revoked sooner.
PRECAUTIONS
Safety Precautions
• The InteliSwab™ COVID-19 Rapid Test Pro Visual Reference Panel does not contain potentially infectious materials. Hazardous
disposal is only required if used in areas containing infectious materials.
• Use of Visual Reference Panels manufactured by any other source will not meet the requirements for an adequate
quality assurance program for the InteliSwab™ COVID-19 Rapid Test Pro.
STORAGE INSTRUCTIONS
Store the InteliSwab™ COVID-19 Rapid Test Pro Visual Reference Panel at 15°-30°C (59°-86°F). Do not use the InteliSwab™
COVID-19 Rapid Test Pro Visual Reference Panel beyond the expiration date printed on the foil pouch. Open the InteliSwab™
COVID-19 Rapid Test Pro Visual Reference Panel pouch only when qualifying new operators in interpreting test results. Reseal
and store the devices in their original foil pouch at 15°-30°C (59°-86°F) after use. If not protected from light or stored above the
indicated temperatures, the un-pouched device should be discarded after 15 days.
DIRECTIONS FOR USE
Test Procedure
Note: The InteliSwab™ COVID-19 Rapid Test Pro Visual Reference Panel should be read and interpreted in the
same location that testing and interpreting the InteliSwab™ COVID-19 Rapid Test Pro occurs.
1. Open the foil pouch containing the InteliSwab™ COVID-19 Rapid Test Pro Visual Reference Panel.
2. Pull out the three devices contained within the foil pouch.
3. Note the date the pouch was opened on the device labels or the pouch label.
4. Follow the Test Result and Interpretation of Test Result section of the InteliSwab™ COVID-19 Rapid Test Pro
Instructions for Use for instructions on how to interpret the devices.
5. Store the InteliSwab™ COVID-19 Rapid Test Pro Visual Reference Panel Devices in the original re-sealable foil
pouch at 15-30°C (59-86°F).
EXPECTED RESULTS
COVID-19 Limit of Detection Device
The COVID-19 Limit of Detection Device has been manufactured to have a very faint reddish-purple line at the Test (T) Zone. A
reddish-purple line should be present in the Result Window in both the Control (C) Zone and the Test (T) Zone. This indicates a
weakly positive test result consistent with the limit of detection of the device. The Control (C) Zone and the Test (T) Zone lines will
not be the same intensity.
COVID-19 Low Positive Device
The COVID-19 Low Positive Device has been manufactured to have a reddish-purple line at the Test (T) Zone. A reddish-purple line
should be present in the Result Window in both the Control (C) Zone and the Test (T) Zone. This indicates a positive test result. The
Control (C) Zone and the Test (T) Zone lines will not be the same intensity.
COVID-19 Negative Device
The COVID-19 Negative Device has been manufactured to have a line at the Control (C) Zone. A single line should be present in
the Result Window in the Control (C) Zone and NO line should be present in the Test (T) Zone. This indicates a negative test result.
NOTE: If a new operator is unable to interpret all devices provided as part of the InteliSwab™ COVID-19
Rapid Test Pro Visual Reference Panel, they are not considered to be proficient at reading and interpreting 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.
LIMITATIONS
The InteliSwab™ COVID-19 Rapid Test Pro Visual Reference Panel is for use only with the InteliSwab™ COVID-19 Rapid Test Pro.