June 29, 2021

Dear [FNAME],

This is the Kaiser Permanente Saliva Home Collection Kit that you requested. This test will ask you  to collect a sample of  your  saliva. Test  results are usually available on kp.org within 48 hours of when we receive your sample.

Please  return  the  sample  back  to  us  using  the  pre-paid  package  enclosed  following  the shipping options on the bottom of this page. Please return sample back on the same day it was collected. For people 18 years old and older.

E

See reverse side for: Sample collection instructions Lab slip and label Important FDA information

**000000001

For use under the Emergency Use Authorization (EUA) only

Shipping Instructions1. You can schedule online to have UPS pick up this package at your address by going to 

wwwapps.ups.com/pickup/schedule (Monday through Friday)  OR2. You can take it to any UPS Store location Monday through Friday (go to 

www.ups.com/dropoff to learn more; be sure to drop off your completed kit before the latest ‘Air’ drop-off time)

Collect your sample (Monday through Friday) on the same day that pick-up, drop-off or shipment is made. Please check the links above ahead of time to plan accordingly.

The Kaiser Permanente Saliva Home Collection Kit contents include: Corrugated box

Saliva collection device with collection instructions

Personalized patient letter with shipping instructions and label

Return shipping recommendations

Biohazard bag with absorbent tissue

Return shipping bag

January 21, 2021

Dear Iuymfu,

This is the Kaiser Permanente Saliva Home Collection Kit that you requested. This test will askyou to collect a sample of your saliva. Test results are usually available on kp.org within 48hours of when we receive your sample.

Please return the sample back to us using the pre-paid package enclosed following theshipping options instructions on the back of this page. Please return sample back on thesame day it was collected. For people 18 years old and older.

E

**

For use under the Emergency Use Authorization (EUA) only

kp.org/coronavirus

At Kaiser Permanente, your health and safety is our top priority. We continue to do everything we can to keep you, our members, and our communities as safe as possible from COVID-19. Here are some tips for returning your COVID-19Saliva Home Collection sample to us for analysis:

Collect Your Saliva and Return the Kit Back to Us the Same Day• Please collect your saliva in the tube provided and return it to us the same day. Your sample can expire if we do not

receive it in a timely fashion.

Tips for Returning Sample Using UPS• If you plan on using UPS, collect and return your sample Monday - Friday using one of these two options

1. Schedule an online UPS pick up at your address by going to: wwwapps.ups.com/pickup/schedule

When to Expect Your Results

How to Get Your Results• Test results are usually available on kp.org or through the Kaiser Permanente mobile app within 48 hours of when

we receive your sample. You need to have a kp.org account or download the mobile app. You can also call 888-457-8378 for your test results.

This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by the Southern California Permanente Medical Group - Regional Reference Laboratory (SCPMG-RRL) locatedat 13000 Peyton Drive, Chino Hills, CA 9170. 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 theduration 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, 21U.S.C. § 360bbb[1]3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

COVID-19 Saliva Home CollectionReturn Shipping Recommendations

If I Ship My Kit Back Using UPS Return Shipping

If I drop off my kit with UPS before the NextDay Air cut-off time on Mon Tues Wed Thurs Fri Weekend UPS Drop Off is

NOT Recommended(There are limited and in somecases no pickups from select UPS stores on weekends, thismay cause your sample to

expire before it reaches our lab)

The lab should receive my kit by(Holidays will delay receipt) Tues Wed Thurs Fri Sat

I can expect to receive my results Wed-Thurs Thurs-Fri Fri-Sat Sat-Sun Sun-Mon

2. Take the package to any UPS store location. Be sure to drop off your completed kit before the latest “Air” drop-off time that day. Go to ups.com/dropoff and clickon the name of the location nearest to you to learn more.

12 01 20 08 33

Wrap the tube in the tissue, place it into this bag and seal it.

12 01 20 08 33

8

Ship the sample back to our lab using the

shipping package. See reverse side for shipping

instructions.

12 01 20 08 33

1 2 3 4 5

12 01 20 08 33

Open sealed container. Pull out the folded instruction sheet, read it, and follow all of the steps

exactly.

Collect the sample following all the steps

exactly.

12 01 20 08 33

6

Place the bag, AND this letter form back into the cardboard box. Seal the

box with tape.

12 01 20 08 33

7

Place it into the pre-paid shipping bag addressed to our lab.

12 01 20 08 33

Write in the date and time of collection on the form AND the

label at the bottom of this page.

Peel the label off and wrap it onto the tube aligning with the existing barcode that is already on the

tube.

Please return sample back on the same day it was collected.

Please write the date and time of collection here

Wash hands prior to sample collection. Do not eat, drink, smoke or chew gum for 30 minutesbefore providing the saliva sample. Do not ingest the liquid in the collection device. Wash withwater if liquid solution comes in contact with eyes or skin. Follow all instructions provided in thecollection device for sample collection. Not following the instructions exactly can lead to incorrectresults.

For use under the Emergency Use Authorization (EUA) only

To see a video that shows you how to complete the test, scan this bar code

• This product is designed for the collection of human saliva samples.

• This  product  has  not  been  FDA  cleared  or  approved  but  has  been  authorized  for emergency use by FDA under an EUA for use by authorized laboratories.

• 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 in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetics Act, 21 U.S.C. § 360bbb-3(b)(1), unless  the declaration  is  terminated, or authorization is revoked sooner.

Complete this section after you collect the sample.

Patient: [FNAME] [LNAME]

Collection date:  _____ / _____ / _____ 

Collection time:  _______ : _______ AM  PM

Please write the date and time of collection here

mm dd yyyy

57-NC-21-007138[MemberID][LNAME], [FNAME][PCP LName], [PCP FName] 

______/______/______

_______:_______ AMPM

mm dd yyyy