Product Manual
MATERIALS PROVIDED
InteliSwab
TM
COVID-19 Rapid Test Pro Kit Controls
Each Kit Control box contains an IFU and two vials (one COVID-19 Positive Control and one COVID-19
Negative Control) as described below:
COVID-19 Positive Control
One blue-capped vial containing 0.25 mL of SARS-CoV-2 nucleocapsid recombinant antigen diluted in Phosphate-Buffered Saline
with 1% Bovine Serum Albumin. Preservative: 2-methyl-4-isothiazolin-3-one.
COVID-19 Negative Control
One white-capped vial containing 0.25 mL of Phosphate-Buffered Saline with 1% Bovine Serum Albumin.
Preservative: 2-methyl-4-isothiazolin-3-one.
Specimen Collection Loops
MATERIALS REQUIRED AND PROVIDED in the InteliSwab
TM
COVID-19 Rapid Test Pro Kit
Divided Pouches, each containing a Test Device, an Absorbent Packet, and a Developer Solution Vial
Test Stands
Instructions for Use
MATERIALS REQUIRED BUT NOT PROVIDED
Timer or watch capable of timing 30 minutes
Latex, vinyl, or nitrile disposable gloves
Biohazard waste container
WARNINGS
For in vitro Diagnostic Use
• These Instructions for Use must be read completely before using the product.
• Follow the instructions carefully when performing the InteliSwab
TM
COVID-19 Rapid Test Pro. Failure to do so
may cause an inaccurate test result.
• This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for
use by authorized laboratories; 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
• Before proceeding with testing, all study personnel MUST read and be familiar with Universal Precautions
2
and Infection Control Guidance for Healthcare Professionals about Coronavirus (COVID-19)
1
.
PRECAUTIONS
Safety Precautions
• Handle Kit Controls and materials in contact with Kit Controls as if capable of transmitting infectious agents.
• Dispose of all Kit Controls and materials used in the test procedure in a biohazard waste container. All equipment
and biohazardous waste should be discarded in accordance with country, state, and local laws and policies.
• Wear disposable gloves while handling and testing the Kit Controls. Dispose of used gloves in a biohazard
waste container.
• 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.
STORAGE INSTRUCTIONS
Store the InteliSwab
TM
COVID-19 Rapid Test Pro Kit Controls at 2°-8°C (36°-46°F). Do not use the Kit Controls beyond the
expiration date printed on the outer box. Open the Kit Control vials only when you are performing tests. Recap and store the vials
in their original box at 2°C-8°C (36°-46°F) after use. Once opened, Kit Controls should be discarded after one week.
DIRECTIONS FOR USE
General Test Preparation
Perform procedures according to the General Test Preparation section of the InteliSwab
TM
COVID-19 Rapid Test Pro IFU.
TEST PROCEDURE
1. Open a Kit Control vial containing the control reagent.
2. Insert the rounded end of an unused Specimen Collection Loop into the vial of control reagent. Visually inspect the
loop to make sure that it is completely filled with the control reagent. Use separate unused Specimen Collection
Loops for each control reagent.
3. Immediately immerse the control-reagent-filled Specimen Collection Loop into the Developer Vial. Use the
Specimen Collection Loop to stir the specimen in the developer solution. Remove the Specimen Collection Loop
from the Developer Vial and discard the used loop in a waste container.
4. Remove the Test Device from the Divided Pouch without touching the flat pad. Insert the Test Device, flat pad first,
into the Developer Vial containing the specimen. Be sure that the Result Window is facing towards you and
the flat pad touches the bottom of the Developer Vial.
5. Leave the Test Device in the Developer Solution Vial and start a timer. Do not remove the Test Device from the
vial until you have read the results. Read the results in a fully lighted area after 30 minutes, but no more than
40 minutes. Read the results as described in the Test Result and Interpretation of Test Result section of the
InteliSwab
TM
COVID-19 Rapid Test Pro Kit IFU.
6. Dispose of the used test materials in a waste container.
EXPECTED RESULTS
COVID-19 Negative Control
The COVID-19 Negative Control will produce a Negative test result. 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.
COVID-19 Positive Control
The COVID-19 Positive Control will produce a Positive test result and has been manufactured to produce a very faint line at the
Test (T) Zone. Two lines should be present in the Result Window. A line in the Control (C) Zone and a line in the Test (T) Zone
should be present. This indicates a Positive test result. The lines will not necessarily be the same intensity.
NOTE: If the test result for either the COVID-19 Negative Control or the COVID-19 Positive Control is not as expected,
the test should be repeated using a new Test Device, Developer Solution Vial and control specimen. Contact OraSure
Technologies’ Customer Care if the Kit Control reagents do not produce the expected result.
LIMITATIONS
The InteliSwab
TM
COVID-19 Rapid Test Pro Kit Controls are quality control reagents for use only with the InteliSwab
TM
COVID-19
Rapid Test Pro.