visby medical COVID-19 Point of Care Test Instruction Manual

COVID-19
Point of Care

Recommended Health Care Provider Collection Instructions
Note: Please swab both nostrils with the same swab. Swab

Step 1 Open the Kit
Wash your hands. Put on a new pair of gloves. Open the specimen collection kit. Set aside the tube.| Step 2 Unwrap the Swab
Hold the swab handle in your hand, by placing it between your thumb and your index finger.
**Do not touch the soft tip of the swab with your finger or on any surfaces. If you do, start again with a new kit.| Step 3 Insert the Swab
Place your index finger directly above the rim of the patient’s nostril. Gently insert the swab into the nose until the swab touches the inner walls of the nose.| Step 4 Collect a Sample
Move the tip of the swab through a large circular path inside the nose. At least four sweeping circles should be performed. This should take approximately 10-15 seconds per nostril. Withdraw the swab slowly. Using the same end of the swab, repeat steps 3-4 with the other nostril.
**Ensure the soft tip does not touch anything after removing it from the nostril.

Step 5 Open the Tube
Carefully unscrew the cap ensuring the soft tip of the swab doesn’t touch anything. Set the cap down.| Step 6 Insert the Swab
Hold the tube opening away from you and carefully insert the soft tip of the swab into the tube.| Step 7 Store the Swab
Once the tip is near the bottom, break the swab handle at the swab breakpoint by bending back and forth or cutting it with sterile scissors. The swab should sit in the tube comfortably so that the cap can be screwed on. Discard the swab handle immediately.| Step 8 Secure the Tube
Screw the cap back on tightly to prevent contamination.

IMPORTANT INFORMATION
Users should read the complete collection procedure before performing specimen collection. Do not over-insert the swab.
This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under a EUA for use by 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., inpatient 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 nucleic acid 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 the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1) unless the declaration is terminated or authorization is revoked sooner.
Recommended Self-Collection Instructions in Health Care Settings
Note: Please swab both your nostrils with the same swab.

Step 1 Open the Kit
Wash your hands. Open the specimen collection kit. Set aside the tube.| Step 2 Unwrap the Swab
Hold the swab handle in your hand, by placing it between your thumb and your index finger.
**Do not touch the soft tip of the swab with your finger or on any surfaces. If you do, start again with a new kit.| Step 3 Insert the Swab
Place your index finger above the rim of your nostril and gently insert the soft tip of the swab into one nostril just until the soft tip is no longer visible (½ to ¾ inch or 1 to 1.5 cm).
**If you experience pain, stop immediately.| Step 4 Collect a Sample
from First Nostril Rotate the swab slowly making
at least four sweeping circles around the inside wall of your nostril. This should take approximately 10-15 seconds per nostril. Withdraw the swab slowly.
****Ensure the soft tip does not touch anything after removing it from the nostril.

Step 5 Collect a  Sample from other Nostril
Use the same swab and repeat Steps 3 & 4. **Keep the swab in your hand during Step 5 and make sure the soft tip does not touch anything after removing the swab from your nostril.| Step 6 Open the Tube
Carefully unscrew the cap ensuring the soft tip of  the swab doesn’t touch anything. Set the cap
down.| Insert the Swab Step 7
Hold the tube opening away from you and carefully insert the soft tip of the swab into the tube.| Store the Swab Step 8
Once the tip is near the bottom, break the swab handle at the swab breakpoint by bending back and forth. The swab should sit in the tube comfortably so that the
cap can be screwed on. Discard the swab handle immediately.| Return Tube Step 9**
Screw the cap back on tightl to prevent contamination. Wash your hands with
soap and water.

Recommended Health Care Provider Collection Instructions
Note: Please swab both nostrils with the same swab. Swab

Step 1 Open the Kit
Wash your hands. Put on a new pair of gloves. Open the specimen collection kit. Set aside the tube.| Step 2 Unwrap the Swab
Hold the swab handle in your hand, by placing it between your thumb and your index finger.
****Do not touch the soft tip of the swab with your finger or on any surfaces. If you do, start again with a new kit.|

Step 3 Insert the Swab
Tilt patient’s head back 70 degrees. Use a flocked tapered swab. Some swabs come with a stopper, which indicates proper nasal insertion depth.
While gently rotating the swab, insert the soft tip of the swab less than one inch (about 2 cm) into the nostril parallel to the palate until resistance is met at turbinates.

| Step 4 Collect a Sample
Rotate the swab several times against the nasal wall. Withdraw the swab slowly. Using the same end of the swab, repeat steps 3-4 with the other nostril.
****Ensure the soft tip does not touch anything after removing it from the nostril.

Step 5 Open the Tube
Carefully unscrew the cap ensuring the soft tip of the swab doesn’t touch anything. Set the cap down.| Step 6 Insert the Swab
Carefully place swab, tip first, into the tube provided.| Step 7 Store the Swab
Once the tip is near the bottom, break the swab handle at the swab breakpoint by bending back and forth or cutting it with
sterile scissors.
The swab should sit in the tube comfortably so that the cap can be screwed on. Discard the swab handle immediately.| Step 8 Secure the Tube
Screw the cap back on tightly to prevent contamination.

Recommended Self-Collection Instructions in Health Care Settings
Note: Please swab both your nostrils with the same swab.

Step 1 Open the
Kit Wash your hands. Open the specimen collection kit. Set aside the tube.| Step 2 Unwrap the Swab
Hold the swab handle in your hand, by placing it between your thumb and your index finger.  Do not touch the soft tip of the swab with your finger or on any surfaces. If you do, start again with a new kit.| Step 3 Insert the Swab
Your sample collection swab includes a stopper that indicates when to stop inserting the swab.
Tilt your head back, look up towards the ceiling, and place your index finger directly above the rim of your nostril.
While gently rotating the swab, insert the soft tip of the swab parallel to the roof of your mouth until the stopper touches the edge of your nostril and you feel resistance
. **If you experience pain, stop immediately.| Step 4 Collect a Sample**
from First Nostril
Rotate the swab several times against the nasal wall. Withdraw the swab slowly.

Step 5 Collect a Sample from Other Nostril
Use the same swab and repeat Steps 3 &4.
**Keep the swab in your hand during Step 5 and make sure the soft tip does not touch anything after removing it from your nostril.| Step 6 Open the Tube
Carefully unscrew the cap ensuring the soft tip of the swab doesn’t touch anything. Set the cap down.1| Insert the Swab Step7 Carefully place swab, tip first, into the tube provided.| Store the Swab Step 8
Once the tip is near the bottom, break the swab handle at the swab breakpoint by bending back and forth. The swab should sit in the tube comfortably so that the cap can be screwed on.
Discard the swab handle immediately.| Return Tube Step 9**
Screw the cap back on tightly to prevent
contamination. Wash your hands with soap and water.

Recommended Health Care Provider Collection Instructions

Step 1 Open the Kit
Wash your hands. Put on a new
pair of gloves. Open the specimen collection kit. Set aside the tube.| Step 2 Unwrap the Swab
Hold the swab handle in your hand, by placing it between your thumb and your index finger.
** Do not touch the soft tip of the swab with your finger or on
any surfaces. If you do, start
again with a new kit.| Step 3 Insert the Swab
Tilt patient’s head back 70 degrees. Gently and slowly insert a mini tip swab with a
flexible shaft through the nostril parallel to the palate until resistance is encountered. The distance is equivalent to that from the nostril to the ear of the
patient, indicating contact with the nasopharynx.| Step 4 Collect a Sample**
Gently rub and roll the swab, leaving it in place for several seconds to absorb secretions. If a deviated septum or blockage creates difficulty in obtaining the
specimen from one nostril, use the same swab to obtain the specimen from the other nostril. Slowly remove swab while rotating it. Specimens can be collected
from both nostrils, but it is not necessary if the swab is saturated with fluid from the first nostril.

Step 5 Open the Tube
Carefully unscrew the cap ensuring the soft tip of the swab doesn’t touch anything. Set the cap down.| Step 6 Insert the Swab
Carefully place swab, tip first,
into the tube provided.| Step 7 Store the Swab
Once the tip is near the bottom, break the swab handle at the swab breakpoint by bending back and forth or cut it with
sterile scissors. The swab should sit in the tube comfortably so that the cap can be screwed on. Discard the swab handle
immediately.| Step 8 Secure the Tube
Screw the cap back on tightly to
prevent contamination.

Recommended Health Care Provider Collection Instructions
NASOPHARYNGEAL SPECIMEN

IMPORTANT INFORMATION
** Users should read the complete collection procedure before performing specimen collection.
This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under a EUA for use by laboratories certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, 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. This product has been authorized only for the detection of nucleic acid 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 the detection and/or diagnosis of COVID-19 under Section
564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
PS-001430 Rev D 02/21**

Documents / Resources

| visby medical COVID-19 Point of Care Test [pdf] Instruction Manual
COVID-19 Point of Care Test
---|---

References

• The Only Instrument-Free, Rapid PCR Test | Visby Medical

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