Saliva Direct At Home Collection Kit User Manual
- August 27, 2024
- Saliva Direct
Table of Contents
Saliva Direct At Home Collection Kit
Product Information
Specifications:
- Product Name: SalivaDirect Funnel Collection Kit
- Intended Use: Saliva collection for testing
- Age Range: Individuals age 18 years or older (self-collected), 14 years and older (self-collected under adult supervision), or 2 years and older (collected with adult assistance)
- Regulatory Status: For Use Under Emergency Use Authorization (EUA) Only
Product Usage Instructions
Warning and Precautions Before Beginning
Before providing your sample, carefully read the instructions below to ensure a good saliva sample:
- Do not force yourself to produce a saliva sample.
- Avoid coughing anything up from your chest or sniffling anything back from your nose into your mouth.
- Avoid eating, drinking, smoking, cleaning teeth, chewing gum, or using nasal sprays for 30 minutes before sample collection.
If you have any questions, contact the support email on the activation card.
Pre-Collection
This test is designed to use saliva naturally collected in your mouth. Follow these steps:
- Visit the FedEx website to find drop box locations and pick-up schedules.
- Identify your sample transport tube and label it with your date of birth.
- Activate your kit using the link on the registration card.
Collecting Your Sample
- Wash hands with soap and water or sanitizer.
- Remove items from the kit and avoid touching the inside of the funnel.
- Position the funnel into the collection tube.
- Swallow once to clear your mouth.
- Allow saliva to collect in your mouth by thinking about food. Release saliva into the funnel gently.
- Collect enough saliva to fill half of the tube. Avoid spitting; gently release saliva into the tube.
- Repeat the process if needed until the tube is half-full. Be patient and avoid forcing it.
Frequently Asked Questions (FAQ)
-
Q: Can children use this kit on their own?
A: Children aged 14 years and older can self-collect under adult supervision, while children aged 2 years and older require adult assistance for collection. -
Q: Can I eat or drink before collecting my saliva sample?
A: It is recommended not to eat, drink, smoke, chew gum, or use nasal sprays for 30 minutes before collecting your saliva sample to ensure accurate results.
The SalivaDirect funnel collection kit.
WARNING AND PRECAUTIONS BEFORE BEGINNING
- Before providing your sample, first carefully read through the instructions below about how to provide a good saliva sample. Not following the instructions could lead to an incorrect result.
- It is very important that you do not force yourself to produce a saliva sample. Please do not cough anything up from your chest. Please do not snif anything back from your nose into your mouth.
- Do not eat, drink, smoke, clean your teeth, chew gum, or use nasal sprays for 30 minutes before collecting your saliva sample.
- If you have any questions, please reach out to the support email on the activation card.
This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA; This product has been authorized only for the collection and maintenance of saliva specimens as an aid in 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 medical devices 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.
Funnel Collection – FedEx Return
IVD For Use Under Emergency Use Authorization (EUA) Only For use by
individuals age 18 years or older (self-collected), 14 years and older (self-
collected under adult supervision), or 2 years and older (collected with adult
assistance).
PRE-COLLECTION
This test is designed to test saliva that naturally collects in your mouth
(for example when you think about a delicious meal).
WARNING: Do not eat, drink, smoke, clean your teeth, chew gum, or use nasal
sprays for 30 minutes before collecting your saliva sample.
-
Visit the FedEx website at fedex.com/labreturns to view drop box locations and pick up schedules. Your sample should be shipped the same day that you collect it. Make sure you can get to your drop box before the last pickup time on the same day you collect your sample. Do not deliver your sample to a drop box on the weekend.
-
Identify your sample transport tube. Using a permanent pen, write your date of birth (MM-DD-YY) on the patient identifier sticker. Remove the adhesive backing from the patient identifier sticker and afx it to the sample transport tube. Do not write on or cover up the printed barcode or ID number on the tube.
-
Activate your kit using the link on the registration card. Follow the instructions on the page to fill in your information.
COLLECTING YOUR SAMPLE -
Wash your hands with soap and water for at least 20 seconds or clean them with alcohol-based sanitizer.
-
Remove everything from the collection kit and place it in front of you. Set the bag aside. Avoid touching the inside of the funnel.
-
Pick up the funnel and the sample tube. Position the funnel into the collection tube as shown.
-
Swallow once to clear your mouth.
-
Imagine eating your favorite food, think about an upcoming meal or even a sour lemon and allow saliva to collect in your mouth. Be patient and it will start to collect! Remember to avoid coughing or snifng.
-
Hold the funnel up so that it surrounds your mouth. Then gently release the saliva that has pooled in your mouth into the funnel.
Please avoid ‘spitting’ into the tube. Saliva should instead be gently released from your mouth. -
Collect enough saliva so the tube is half-filled. Any bubbles in the tube do not count towards the final volume.
You may have to repeat this process a couple of times until the tube is half- full.
Be patient and don’t force it. Just keep thinking about food and you’ll get there! -
Once you have collected enough saliva, remove the funnel from the sample tube and tightly screw the cap back onto the tube. Make sure the cap is secure before proceeding to the next step.
-
Use the alcohol wipe to wipe your hands and the sample tube. DO NOT wipe the printed part of the label.
-
Place the closed sample tube into the biospecimen bag.
-
Discard the alcohol wipe and used funnel.
-
Wash your hands thoroughly with soap and water or clean them with alcohol-based sanitizer.
RETURNING YOUR SAMPLE -
Place the biospecimen bag into the SalivaDirect-labeled box it came in. Place the SalivaDirect-labeled box into the FedEx UN 3373 Pak.
-
Remove the adhesive liner of the FedEx UN 3373 Pak and press down firmly to seal Pak tightly.
-
Please drop of your sample on the same day you collect it and before the last pickup time. Do not deliver your sample to a drop box on the weekend.
Welcome to the SalivaDirectTM At-Home Collection Kit
Please read through this entire document and collection kit instructions. If
you have any questions, please reach out to the support email on the
activation card.
-
ACTIVATE YOUR KIT
Before collecting your sample, activate your kit online using the link on the activation card. Follow the instructions on the page to fill in the necessary contact information to tie your sample to your results. -
COLLECT YOUR SAMPLE
Collect your sample following the full instructions. Do not eat, drink, smoke, clean your teeth, chew gum, or use nasal sprays for 30 minutes before collecting your saliva sample. -
SHIP BACK YOUR SAMPLE SAME DAY
Your sample should be shipped the same day it is collected. See the collection brochure for more information.
COMPONENTS
REMINDERS & TIPS
- Make sure you are able to drop of your box before the last pickup time on the same day you collect your sample. Do not deliver your sample to a drop box on the weekend.
- Use a permanent pen or marker when labeling your collection tube.
This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA; This product has been authorized only for the collection and maintenance of saliva specimens as an aid in 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 medical devices 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. IVD | For Use Under Emergency Use Authorization (EUA) Only For use by individuals age 18 years or older (self- collected), 14 years and older (self-collected under adult supervision), or 2 years and older (collected with adult assistance)
The SalivaDirect bulb pipette collection kit PRE-COLLECTION
This test is designed to test saliva that naturally collects in your mouth
(for example when you think about a delicious meal).
WARNING : Do not eat, drink, smoke, clean your teeth, chew gum, or use
nasal sprays for 30 minutes before collecting your saliva sample.
-
Visit the UPS website at ups.com/dropof to view drop box locations and pick up schedules. Your sample should be shipped the same day that you collect it. Make sure you can get to your drop box before the last pickup time on the same day you collect your sample. Do not deliver your sample to a drop box on the weekend.
-
Identify your sample transport tube. Using a permanent pen, write your date of birth (MM-DD-YY) on the patient identifier sticker. Remove the adhesive backing from the patient identifier sticker and afx it to the sample tube. Do not write on or cover up the printed barcode or ID number on the tube.
-
Activate your kit using the link on the registration card. Follow the instructions on the page to fill in your information.
-
Wash your hands with soap and water for at least 20 seconds or clean them with alcohol-based sanitizer.
-
Remove everything from the collection kit, place in front of you, and set the bag aside.\
COLLECTING YOUR SAMPLE -
Unscrew the cap from the labelled collection tube.
-
Place the open tube in front of you so that it is standing upright. You may place the cap to the side for now.
-
Open the bulb pipette packaging starting at the end with the bulb (see illustration).
-
Swallow once to clear your mouth.
-
Imagine eating your favorite food, think about an upcoming meal or even a sour lemon and allow saliva to collect in your mouth.
Be patient and it will start to collect! Remember to avoid coughing or snifng. -
Pick up the bulb pipette and press the bulb end between your index finger and thumb to push out all of the air.
-
Keeping your lips mostly closed, gently insert the tip into your mouth where saliva is collecting.
-
Gently release your finger and thumb to allow the bulb pipette to fill with saliva. Please avoid ‘spitting’. Saliva should instead be gently released from the mouth.
-
Remove the bulb pipette from your mouth and pick up the sample tube with your other hand.
-
Carefully insert the tip of the bulb pipette into the sample tube. Then gently push down on the bulb to slowly empty the saliva into the tube.
-
Repeat steps 10-15 until the sample tube is about half filled. Any bubbles in the tube do not count towards the final volume. You may have to repeat this process a couple of times until the tube is half-full. Be patient and don’t force it. Just keep thinking about food and you’ll get there!
-
Once you have collected enough saliva, tightly screw the cap back onto the sample tube. Make sure the cap is secure before proceeding to the next step.
-
Use the alcohol wipe to wipe your hands and the sample tube. DO NOT wipe the printed part of the label.
-
Place the closed sample tube into the biospecimen bag.
-
Discard the alcohol wipe and used bulb pipette.
-
Wash your hands thoroughly with soap and water or clean them with alcohol-based sanitizer.
RETURNING YOUR SAMPLE -
Place the biospecimen bag into the SalivaDirect-labeled box it came in. Place the SalivaDirect-labeled box Express Pak
into the UPS Category B Pak. Remove the adhesive liner of the UPS Category B Pak and press down firmly to seal Pak tightly. Please drop of your sample on the same day you collect it and before the last pickup time. Do not deliver your sample to a drop box on the weekend.
The SalivaDirect straw collection kit PRE-COLLECTION
This test is designed to test saliva that naturally collects in your mouth
(for example when you think about a delicious meal).
WARNING: Do not eat, drink, smoke, clean your teeth, chew gum, or use nasal
sprays for 30 minutes before collecting your saliva sample.
-
Visit the FedEx website at fedex.com/labreturns to view drop box locations and pick up schedules. Your sample should be shipped the same day that you collect it. Make sure you can get to your drop box before the last pickup time on the same day you collect your sample. Do not deliver your sample to a drop box on the weekend.
-
Identify your sample transport tube. Using a permanent pen, write your date of birth (MM-DD-YY) on the patient identifier sticker. Remove the adhesive backing from the patient identifier sticker and afx it to the sample transport tube. Do not write on or cover up the printed barcode or ID number on the tube.
-
Activate your kit using the link on the registration card. Follow the instructions on the page to fill in your information.
COLLECTING YOUR SAMPLE -
Wash your hands with soap and water for at least 20 seconds or clean them with alcohol-based sanitizer.
-
Remove everything from the collection kit and place it in front of you. Set the bag aside. Avoid touching the inside of the collection device.
-
Unscrew the collection tube cap and insert the rigid end of the saliva straw into the collection tube. Swallow once to clear your mouth.
-
Imagine eating your favorite food, think about an upcoming meal or even a sour lemon and allow saliva to collect in your mouth. Be patient and it will start to collect! Remember to avoid coughing or snifng.
-
Pool saliva in mouth and push saliva into the straw until the collection tube is at least half full (1mL) and no more than ¾ full.
-
Remove and discard straw and securely cap the collection tube.
-
Use the alcohol wipe to wipe your hands and the sample tube. DO NOT wipe the printed part of the label.
-
Place the closed sample tube into the biospecimen bag.
-
Discard the alcohol wipe and wash your hands thoroughly with soap and water or clean them with an alcohol-based sanitizer.
RETURNING YOUR SAMPLE -
Place the biospecimen bag into the SalivaDirect-labeled box it came in. Place the SalivaDirect-labeled box into the FedEx UN 3373 Pak.
-
Remove the adhesive liner of the FedEx UN 3373 Pak and press down firmly to seal Pak tightly.
-
Please drop of your sample on the same day you collect it and before the last pickup time. Do not deliver your sample to a drop box on the weekend.
COMPONENTS
Documents / Resources
|
Saliva Direct At Home Collection
Kit
[pdf] User Manual
At Home Collection Kit, At Home, Collection Kit, Kit
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