labcorp Mpox PCR Test Home Collection Kit Instructions
- June 14, 2024
- labcorp
Table of Contents
labcorp Mpox PCR Test Home Collection Kit
Product Information
- Specifications:
- Intended Use: Rx only
- For at-home collection of lesion swab specimens
- For individuals 18 years of age or older
- Authorized for emergency use by FDA under EUA
- Aid in the detection of nucleic acid from non-variola Orthopoxvirus
- Collection Kit Components:
- Specimen confirmation form
- Collection tube (cap colour may vary)
- Collection swab
- Biohazard specimen bag with absorbent sheet
- White shipping box
- FedEx Pak UN 3373
- Collection Process:
- Avoid contact with eyes and keep out of reach of children.
- Read all instructions carefully before beginning the collection.
- Use the provided swab to collect the lesion specimen as directed.
- Place the swab in the collection tube and secure the cap.
- Place the collection tube in the biohazard specimen bag.
- Shipping Instructions:
- Ship the specimen via FedEx on the same day you collect it, Monday through Thursday.
- Do not ship the kit on Friday, Saturday, or Sunday.
- Schedule a FedEx pickup by calling 800-463-3339 and following the provided script.
- Visit https://bit.ly/fedexdropbox to locate FedEx drop box locations.
FAQs
- Q: Can I collect the specimen and ship it on any day of the week?
- A: No, the specimen must be shipped via FedEx on the same day of collection, Monday through Thursday.
- Q: What should I do if I miss the FedEx pickup times?
- A: Contact FedEx to reschedule a pickup for the next available weekday.
- Q: Is it safe to use the collection kit for children under 18 years of age?
- A: No, this kit is intended for individuals 18 years of age or older as specified in the instructions.
PRODUCT INTRODUCTION
Ship the Specimen to LabCorp via FedEx
The specimen must be shipped Monday through Thursday on the same day that you collect it.
- Visit https://bit.ly/fedexdropbox to view FedEx drop box locations and pickup schedules.
- You have 2 options for shipping the sample.
FedEx Drop Box
- It’s important to bring your specimen to a drop box on the same day you collect it before the last Express pick-up.
- Deliver your specimen to a drop box Monday through Thursday.
- Do not take it to a FedEx office.
- Do not place the kit in the drop box on Friday, Saturday or Sunday.
Schedule a FedEx Pickup
- Schedule your FedEx pickup for a weekday (Monday through Thursday). Call FedEx at 800-463-3339 and follow the script below.
- FedEx: “What are you calling about?” You: “FedEx Express® return pickup”
- FedEx: “…a pickup request for a return. To arrange a pickup for today or tomorrow, depending on availability, say “pickup.” You: “Pickup”
- FedEx: “Is the word “stamp” written anywhere on your return label?” You: “No”
- FedEx: “What is the tracking number?” You: Provide the tracking number (TRK#) from the return label
- FedEx: “What kind of return are you calling about?” You: “FedEx Express”
- Provide additional information as requested. You may be asked for the pickup location address, number of packages to be picked up, day and time window for the pickup, or if your shipment is currently ready.
- Note the confirmation pickup number provided. If you are asked for a credit card or account number, state that this is a FedEx Express return pickup and provide the tracking number (TRK#) from the return label.
Do not collect your specimen until you confirm pickup times of the drop box or have confirmed your scheduled pickup.
PRODUCT USING INSTRUCTIONS
Please read instructions carefully and follow directions step by step.
Kit includes:
DISCLAIMER
-
Intended use: Rx only For the at-home collection of lesion swab specimens, for in vitro diagnostic testing in a CLIA- Intended use: Rx only. certified laboratory, by individuals 18 years of age or older (self-collected), presenting with acute, generalized pustular or vesicular rash suspected of Mpox illness when determined to be appropriate by a healthcare provider.
-
This product has not been FDA-cleared or approved but has been authorized for emergency use by the FDA under an EUA for use by the
authorized laboratories. -
This product has been authorized only for the collection and maintenance of lesion swab specimens as an aid in the detection of nucleic acid from non-variola Orthopoxvirus, including the Mpox virus. Not for use 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 infection with the Monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, 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.
Home Collection Kit Instructions
Mpox PCR Test Home Collection Kit Instructions For In Vitro Diagnostic Use
- Please read all instructions carefully before beginning collection and follow directions step by step. Ship the specimen Monday through Thursday and on the same day you collect it. To report a missing item in the kit or to request a new kit, visit https://patient.labcorp.com/v1/homekit-issue/form.
- Visit https://bit.ly/fedexdropbox to view FedEx drop box locations and pickup schedules. It’s important to bring your sample to a drop box on the same day you collect it before the last Express pickup. Or refer to the flyer in your kit to schedule a FedEx pickup on the day of collection.
- Remove contents from the kit box and place them on a clean, dry and flat surface.
- Wash and dry hands thoroughly. Take the swab out of its package. Do not touch the tip of the swab with your hands or touch any other surfaces with the swab tip. If the swab touches any other surface, request a new kit. Do not clean the lesion before collecting the sample.
- Slowly swirl the swab while pressing firmly across the entire lesion at least 3 times. Make sure you press firmly with the swab to collect the lesion material. If you have multiple lesions, swab one at an intermediate stage (not brand new, not old and healing).
- Unscrew the top of the collection tube. Hold the swab in one hand and the collection tube in the other, being careful not to spill the liquid. If the liquid spills request a new kit. Do not drink the liquid.
- Insert the swab into the collection tube. The end of the swab that was used to swab the lesion should be placed into the tube first. Break at the score line to allow the tube to be tightly closed. Screw the top of the collection tube back on tightly.
- Wash and dry hands thoroughly again. Insert the collection tube into the biohazard specimen bag. Seal the biohazard specimen bag by closing the zip lock seal. Do not remove the absorbent sheet from the biohazard specimen bag.
- Fill out the specimen confirmation form. In ink, include the date and time of collection in the Patient Section.
- Place the specimen bag and specimen confirmation form into the white shipping box and close the lid. Place the shipping box into the FedEx return pack. Remove the adhesive cover strip and seal the FedEx return pack closed. Do not place the collection tube directly in the FedEx return pack for shipment.
- Deliver the postage-paid, pre-addressed FedEx Pak to a FedEx drop box. It’s important to bring your sample to a drop box on the same day you collect it before the last Express pickup Monday-Thursday (no weekends) or refer to the flyer in your kit to schedule a FedEx pickup on the day of collection.
- Results are delivered to the ordering healthcare provider and are also available in the Labcorp PatientTM Portal. Visit labcorp.patient.com or use the Labcorp Patient mobile app to set up or access your account. To view a dependent’s results, add them to your account.
CONTACT
- Customer support can be reached at[email protected]. or 1-800-833-3935