Instructions for SpecimenPreparation and Handling

Store serum sample at 2-8 degrees Celsius until the sample can be packaged following the shipping and handling instructions. Unfrozen samples must be received in the laboratory within 8 days of collection.

SAMPLE STORAGEComplete the Test Requisition Form including the following: collection date and time, patient’s first and last name, patient’s DOB, last four digits of the patient’s SSN, practitioner’s name and signature, ICD-10 codes, and patient’s billing information.

Providing Menopausal Status is important to reduce delays in testing.

REQUISITION REQUIREMENTS

Fill out the patient name and date of birth on barcoded labels provided in the kit. Apply one barcode label to each tube, and one barcode label to each copy of the Test Requisition Form. Return any leftover labels with the sample.

LABELING POLICY

Specimens not properly identified with two unique identifiers will not be accepted by the laboratory.

STEP 1

NOTE: Place the ice pack, or the entire small kit containing the ice pack, in the freezer for at least 24 hours prior to packing the specimen.

Draw 8.5 mL of the patient’s blood by performing a standard venipuncture procedure using a Serum Separation Tube (Tiger top).

STEP 2

Mix the blood in the tube by inverting 5 times.

Place a barcode label on the SST (Tiger top) to identify and labelthe sample.

Place tube in an upright position and allow the blood to clot for 30 minutes, but no longer than 2 hours.

Once the sample has completed clotting, centrifuge using manufacturer’sinstructions.

Document the time and date of blood draw on the Test Requisition Form.

Record the phlebotomist’s initials.

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Note: Missing or incomplete test requisition information will delay processing and extend turnaround time.

To receive additional specimen transport kits Call (844) 277-4721

12117 Bee Caves Rd. Building III, Suite 100 Austin, TX 78738

Tel: (844) 277-4721 Fax: (866) 283-3634 e-mail: support@ASPiRALAB.com

CLIA: 45D2073394 CAP: 9021192 NYS: 8885 Laboratory Director: Dr. Herbert Fritsche PhD

Laboratory Test Requisition FormTO AVOID DELAYS PLEASE COMPLETE FIELDS IN REDCollection Date: _____________ Phlebotomist Initials: ________

+

© 2019 ASPiRA LABS CPT is registered trademark of AMA PRC001350 v. 3.00

Physician Office Draw Site:_____________________ Other

VDS-125 [FEMALE SERUM ONLY]

PHYSICIAN INFORMATION PATIENT INFORMATION & AUTHORIZATION

Caucasian Ashkenazi Jewish Sephardic Jewish Asian

Hispanic Native American African American

Other:____________________

Insurance Information: Attach a copy of front and back of patient insurance card and complete. Primary insurance carrier: __________________________________________ Member ID#: _______________________ Group ID#: __________________

Secondary insurance carrier: _______________________________________ Member ID#: _______________________ Group ID#: __________________

Relationship to insured:

Private Insurance Medicare* Patient Self-Pay Medicaid Ordering Facility (Client Bill)

BILLING INFORMATION

Bill the Following (required):

Name of insured: Last: __________________ First: ______________________ DOB: _ _/ _ _/ _ _ _ _

I have provided informed consent for the above ordered test.

Physician’s Signature: ___________________________________________

Print Name: _____________________________________ Date: ________

PHYSICIAN SIGNATURE

* By ordering this test for your Medicare patient, you are certifying that the patient has met the requirements for use i.e. has an ovarian mass, has surgery planned and is over 18 years of age.

CLINICAL INFORMATION

I authorize ASPiRA LABS to release medical information related to services provided herein and authorize payment directly to ASPiRA LABS. More information is available at https://vermillion.com/about-us/legal/ I agree to assume responsibility for payment of charges that are not covered by my healthcare insurer.

**Patient’s Signature: _________________________________________ **patients signature required for verification of benefits Print Name: _________________________________ Date: _________

Quest National Account #: 97513526

OVA1®plus is a reflex test in which OVA1® is performed and then reflexes to OVERA® if the OVA1® result is in the intermediate range. This testing assesses the likelihood that an ovarian mass is malignant prior to planned surgery.

R19.05 Periumbilical swelling,mass and lump+

R19.09 Other intra-abdominal pelvic swelling, mass and lump+

R19.03 Right lower quadrant abdominal swelling, mass and lumpR19.04 Left lower quadrant abdominal swelling, mass and lump+

This is provided for informational purposes only and is not a guarantee of coverage. It is the provider’s responsibility to determine the appropriate codes.Other ICD-10 Codes: _______ _______ _______ _______ _______ _______+

unspecified site+

N83.209 Unspecified ovarian cyst, unspecified side+

R19.00 Intr a-abdominal and pelvicswelling, mass and lump,

N83.201 Unspecified ovariancyst, right side+

N 83.202 Unspecified ovariancyst, left side+

TEST REQUEST FOR OVA1

Feel full quickly or unable to eat normally?

Does the patient:

Have pain in the abdomen or pelvis?

YesNo If YES:

Experience abdominal bloating or an increased abdominal size?

6-12 daysays per long:

How many days per month?How many dFor how long: <1 monthFor how 7-12months

>12 days>12 months

6-12 daysHow many days per month?How many dFor how long: <1 monthFor how

ays per long: 7-12months

>12 days>12 months

6-12 daysHow many days per month?How many dFor how long: <1 monthFor how

ays per long: 7-12months

>12 days>12 months

Menopausal Status: Pre-Menopausal Post-Menopausal Ultrasound Results: Low Risk High Risk Not DefinitiveDate of last menstrual period: _____________________________ Size of mass (longest dimension): ______________ Height: _________ Weight: __________

Last name: ___________________ First Name: ______________________

Address: _______________________________________________________

City: _______________________ State: _______ Zip Code: ___________

SSN: ___________________ DOB (mm/dd/yy): __ __ / __ __ / __ __ __ __

Phone number: _________________________________________

Email address: __________________________________________________Ethnicity (Check all that apply) :

DIAGNOSIS CODES | ICD-10 Codes (check all that apply): Spouse Dependent OtherSelf

0-5 days1-6 months

0-5 days1-6 months

0-5 days1-6 months

Physician name(s): _________________________ NPI#: ____________

Name/Account #: ____________________________________________

Address: ____________________________________________________

City: _____________________ State: ______ Zip Code: ___________

Phone: ______________________ Fax: ___________________________

Fax copy to: _________________________________________________

12117 Bee Caves Rd. Building III, Suite 100 Austin, TX 78738

Tel: (844) 277-4721 Fax: (866) 283-3634 e-mail: support@ASPiRALAB.com

CLIA: 45D2073394 CAP: 9021192 NYS: 8885 Laboratory Director: Dr. Herbert Fritsche PhD

Laboratory Test Requisition FormTO AVOID DELAYS PLEASE COMPLETE FIELDS IN REDCollection Date: _____________ Phlebotomist Initials: ________

+

© 2019 ASPiRA LABS CPT is registered trademark of AMA PRC001350 v. 3.00

Physician Office Draw Site:_____________________ Other

VDS-125 [FEMALE SERUM ONLY]

PHYSICIAN INFORMATION PATIENT INFORMATION & AUTHORIZATION

Caucasian Ashkenazi Jewish Sephardic Jewish Asian

Hispanic Native American African American

Other:____________________

Insurance Information: Attach a copy of front and back of patient insurance card and complete. Primary insurance carrier: __________________________________________ Member ID#: _______________________ Group ID#: __________________

Secondary insurance carrier: _______________________________________ Member ID#: _______________________ Group ID#: __________________

Relationship to insured:

Private Insurance Medicare* Patient Self-Pay Medicaid Ordering Facility (Client Bill)

BILLING INFORMATION

Bill the Following (required):

Name of insured: Last: __________________ First: ______________________ DOB: _ _/ _ _/ _ _ _ _

I have provided informed consent for the above ordered test.

Physician’s Signature: ___________________________________________

Print Name: _____________________________________ Date: ________

PHYSICIAN SIGNATURE

* By ordering this test for your Medicare patient, you are certifying that the patient has met the requirements for use i.e. has an ovarian mass, has surgery planned and is over 18 years of age.

CLINICAL INFORMATION

I authorize ASPiRA LABS to release medical information related to services provided herein and authorize payment directly to ASPiRA LABS. More information is available at https://vermillion.com/about-us/legal/ I agree to assume responsibility for payment of charges that are not covered by my healthcare insurer.

**Patient’s Signature: _________________________________________ **patients signature required for verification of benefits Print Name: _________________________________ Date: _________

Quest National Account #: 97513526

OVA1®plus is a reflex test in which OVA1® is performed and then reflexes to OVERA® if the OVA1® result is in the intermediate range. This testing assesses the likelihood that an ovarian mass is malignant prior to planned surgery.

R19.05 Periumbilical swelling,mass and lump+

R19.09 Other intra-abdominal pelvic swelling, mass and lump+

R19.03 Right lower quadrant abdominal swelling, mass and lumpR19.04 Left lower quadrant abdominal swelling, mass and lump+

This is provided for informational purposes only and is not a guarantee of coverage. It is the provider’s responsibility to determine the appropriate codes.Other ICD-10 Codes: _______ _______ _______ _______ _______ _______+

unspecified site+

N83.209 Unspecified ovarian cyst, unspecified side+

R19.00 Intr a-abdominal and pelvicswelling, mass and lump,

N83.201 Unspecified ovariancyst, right side+

N 83.202 Unspecified ovariancyst, left side+

TEST REQUEST FOR OVA1

Feel full quickly or unable to eat normally?

Does the patient:

Have pain in the abdomen or pelvis?

YesNo If YES:

Experience abdominal bloating or an increased abdominal size?

6-12 daysays per long:

How many days per month?How many dFor how long: <1 monthFor how 7-12months

>12 days>12 months

6-12 daysHow many days per month?How many dFor how long: <1 monthFor how

ays per long: 7-12months

>12 days>12 months

6-12 daysHow many days per month?How many dFor how long: <1 monthFor how

ays per long: 7-12months

>12 days>12 months

Menopausal Status: Pre-Menopausal Post-Menopausal Ultrasound Results: Low Risk High Risk Not DefinitiveDate of last menstrual period: _____________________________ Size of mass (longest dimension): ______________ Height: _________ Weight: __________

Last name: ___________________ First Name: ______________________

Address: _______________________________________________________

City: _______________________ State: _______ Zip Code: ___________

SSN: ___________________ DOB (mm/dd/yy): __ __ / __ __ / __ __ __ __

Phone number: _________________________________________

Email address: __________________________________________________Ethnicity (Check all that apply) :

DIAGNOSIS CODES | ICD-10 Codes (check all that apply): Spouse Dependent OtherSelf

0-5 days1-6 months

0-5 days1-6 months

0-5 days1-6 months

Physician name(s): _________________________ NPI#: ____________

Name/Account #: ____________________________________________

Address: ____________________________________________________

City: _____________________ State: ______ Zip Code: ___________

Phone: ______________________ Fax: ___________________________

Fax copy to: _________________________________________________

To receive additional specimen transport kitsCall (844) 277-4721

© 2020 ASPIRA Women’s Health Inc. All rights reserved. The ASPIRA Labs® and ASPIRA GENETIX logos are trademarks and registered trademarks of ASPIRA Women’s Health in the U.S. and other countries. ASPIRA Women’s Health reserves the right to change this document at any time without notice and disclaims liability for editorial, pictorial or typographical errors.

CUSTOMER SUPPORT

PRC000198 v 5.00

(844) 277-4721 | aspirasupport@aspirawh.comwww.AspiraWH.com

ASPIRA LABS12117 Bee Caves Rd, Building III, Suite 100Austin, TX 78738

Note: Place the ice pack in the freezer for at least 24 hours prior to packing the specimen. Store serum sample at 2-8°C until the sample can be packaged following the instructions below.

PACKAGING AND SHIPPING INSTRUCTIONS

STEP 1

Place the Serum Separator Tube into the biohazard bag. Remove the excess air and seal the bag along the zippered track.

Fold the Test Requisition Form into quarters and place in the side pocket of the biohazard bag along with leftover labels.

STEP 2

Place the lid on the foam cooler ensuring the lid is completely closed.

Close the kit box and affix the Shipping Label provided to the outside of the kit box.

STEP 3

Contact FedEx online or call 1-800-463-3339 to schedule a pick up. Kits may also be dropped off at a FedEx shipping location.

Remove the lid from the foam cooler. Place the frozen ice pack at in the bottom of the foam cooler.

Place the biohazard bag with the Serum Separator Tube on top of the ice pack.

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