FAQs
How much does an AAV5 test cost?
The AAV5 NAb Test is provided by CSL Behring at no cost to the patient or HTC/HCP. (Offer to order NAb Test Kit.)
Will CSL provide the AAV5 Neutralizing Antibody test?
Healthcare professionals can request the AAV5 Neutralizing Antibody Test through HEMGENIX Connect. Would you like for me to place an order? Specimen collection kits will be received within 1-2 business days after the order is placed.
List the Items provided within the Test Kit
SS Tube (1)
Cryovials (2)
Transfer Pipette (1)
Instructions for Use (1)
Specimen ID Stickers for Test Requisition Form (2)
Biohazard Bag (1)
Cryosleeve (1)
Courier Return Air Waybill (1)
Return Shipper (1)
I have a patient coming in today and I can't get access to my account. What can I do?
-I can request that you are added to the account for this facility. It usually takes about 4 hours for account creation, but I will request that this is marked as urgent.
- The time from specimen collection to freezing should not exceed 2 hours.
-Sample cryovials may be stored at -70C or below for up to 4 weeks until ready for shipment.
What do I need to do on the day of shipment before I send the test kit out?
IFU Shipping: On the day of shipment and using the cryosleeve and biohazard bag provided, place the cryovials into the cryosleeve and the crysleeve into the biohazard bag. Seal the biohazard bag.
Fill the return shipper with about 2.5 Kg of dry ice.
Place the completed TRF in the biohazard bag using the document pouch....
What is the shelf life and storage temperature of the sample collection kit?
The expiration date is printed on the label. Do not use past the expiration date printed on label. The kit can be stored at 4-25°C.
Where do I find my account information?
You will receive an email from Precision for Medicine. Look for an email from Precision Customer Support with the email support@precisionmedicinelab.com.
Refer to LIS Portal Instruction Document. If Answer cannot be found fill out Customer Request Form and email to Precision for Medicine at Support@precisionmedicinelab.com
How can you store the kits while not in use?
All components of the PfM Convenience kit can be stored at 4-25 degrees Celsius until ready for collection.
I am trying to understand how to read these results. What does this titer mean?
I'm happy to transfer you over to our Medical Information team who can reference the HEMGENIX prescribing information in more detail. They will be able to answer your questions around test results.
I am having trouble viewing a test result.
Where do you find the answer to this issue?
View page 9 of the Portal Instructions. Offer to send a copy to the caller and walk them though the steps.
The test report is not showing up in the portal?
I cannot see test results, so I will follow up with the lab to request an update. What is the best time for me to call you back and the best number?
Fill out Customer Request Form and email to Precision for Medicine at Support@precisionmedicinelab.com
How long does it take to get the test result?
The results should be available within 2 weeks of receipt. When did you send in the sample?
I cannot see test results, so I will follow up with the lab for an update. What is the best time to call and the best number?
Fill out Customer Request Form and email to Precision for Medicine at Support@precisionmedicinelab.com
How does the Vacuette SS tube work?
The Vacuette SS tubes are plastic tubes with a pre-defined vaccum for exact draw volumes...
When can I expect to see the test results?
The results should be available within 2-3 weeks of receipt. When did you send in the sample?
I can reach out to the lab to ask for a status update.
I am having trouble logging in.
Where do you find assistance for this question?
See page 3 of the portal instructions.
What is the time duration from specimen collection to freezing?
The time from specimen collection to freezing should not exceed 2 hours.
Offer to re-order any kits if needed.
Can I test my patient that is turning 18?
The AAV5 neutralizing Antibody test that we can ship to you is only to be used when screening eligibility for HEMGENIX. HEMGENIX is approved for adults aged 18 years and over. CSL recommends using the test for patients that fall within the indication.
Further questions, refer the caller to the Medical Information Team.
What are these stickers for in the test kit?
Specimen Labeling - The SS tube and the 2 cryovials in the kit are pre-labeled with a bar code that identifies the unique specimen. Fill in the PfM patient ID (this code is listed on part 1 of the TRF) and the date of collection (YYYY-MM-DD) where indicated in the blank sections on the labels. Use a solvent and water resistant permanent marker.
Is it okay if I lost a piece of the collection kit? I found a replacement part in he office.
Use a new collection kit. Do not mix and match collection kit components.
Offer to order a new kit
Is a AAV5 netralizing antibody test required for HEMGENIX?
No, NAb testing is not required per our approved labeled indication in order to receive HEMGENIX. However, one patient who did not respond to treatment was found to have a very high AAV5 NAb titer level.
Although there is no FDA-approved AAV5 NAb assay, CSL will make available a laboratory developed, CLIA-validated test that was used during the clinical trial.
How long can a sample be stored prior to shipment?
Sample cryovials may be stored at -70C or below for up to 4 weeks until ready for shipment.
Further questions, refer the caller to the Medical Information Team.
How can I be added to the portal?
Collect HCP information and submit request to PfM, then follow up with provider after account has been created to ensure they received their username email
Fill out Customer Request Form and email to Precision for Medicine at Support@precisionmedicinelab.com
How much dry ice do I need to add before I ship?
It is recommended that 5 Kg of dry ice is used for routine shipments.
Where do I ship the sample?
Ship frozen samples on dry ice to Precision For Medicine at 8425 Precision Way, Suite M, Frederick, MD 21701 USA. Follow the shipping instruction in the Instruction for Use.
How am I supposed to understand the test results?
Any test result questions not related to accessing results.
I am happy to transfer you over to our Medical Information team who can reference the HEMGENIX prescribing information in more detail. They will be able to answer your questions around test results.