a) Whenever possible, ship within 24 hours of drawing sample. Proprietary stabilizers within the cfD tubes DO allow samples collected on Friday to be shipped on Monday.

b) Affix the FedEx airway bill (or other pre-ap-proved carrier) pouch to the outside of the FedEx Clinical Pak. Insert the airway bill into the pouch.

c) Package up to 4 shipper kits inside FedEx ClinPak, then seal the pouch closed. Ensure patient information is not visible.

The Harmony Prenatal Test is developed by Ariosa Diagnostics. Ariosa Diagnostics is a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). As with other laboratory-developed tests, this testing service has not been cleared or approved by the US FDA or any other federal regulatory agencies. Non-invasive prenatal testing services (NIPT) based on cell-free DNA analyses are not diagnostic; results should be confirmed by diagnostic testing.

5

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Harmony Sample Collection Instructions

24HOURS

Collect specimen by venipuncture directly into the tube (use only the tubes provided). Recommend using a 21 gauge straight needle. Fill both tubes with blood. Enter draw date on Test Requisition Form (TRF).

a) Clearly write the patient’s full name and date of birth on tube barcodes.

b) Patient information on the tube (barcode, patient’s name, date of birth) must match the barcode, patient name, and date of birth on the test requisition form.

c) Place barcode labels lengthwise in the center of the blood tubes.

d) Store and ship filled collection tubes at room temperature.

DO NOT refrigerate or freeze the filled collection tubes.

DO NOT refrigerate or freeze the gel pack.

Fill tube to capacity, do not underfill or overfill. Tubes with low blood volume cannot be accepted for processing. Immediately invert both tubes tubes 8 to 10 times each.

a) Insert collection tubes into the absorbent sleeve.

b) Place the tubes into the biohazard bag and then seal.

c) Fold the gel pack over the biohazard bag.

d) Place all contents into the silver protective pouch and seal.

e) Place the silver pouch and matching test requisition form into the Harmony shipper box and close.

8-10x

Collect Blood

Add Barcode Labels to Tubes/Fill Out TRF

Package

Ship

Mix Blood Sample

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CAUTION: Failure to comply with these sample collection, labeling and shipping instructions may result in degraded samples that are not suitable for performance of the test. These instructions are subject to the terms and conditions on the outer packaging box.

AD12345680-PAT

AD12345680-BLD1

Name: ________ DOB 1 9 8 4 0 6

AD12345680-BLD2

Name: ________ DOB 1 9 8 4 0 6

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GEL PACK

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Two bloodcollection tubes One absorbent sleeve

One biohazard bag One gel pack

One silverprotective pouch

Store kits and contents at room temperatureDo not freeze or refrigerate

Do not use expired kits/tubes

Always store kits and gel packs at room temperature. DO NOT place test requisition form into the biohazard bag

Failure to comply with these labeling instructions may result in rejected samples.

One outer samplecollection box

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Testing Services by Ariosa Diagnostics

© 2016 Ariosa Diagnostics, Inc. All Rights Reserved. ARIOSA, the Ariosa Logo, ARIOSA DIAGNOSTICS, the Ariosa Diagnostics Logo, HARMONY PRENATAL TEST and HARMONY are trademarks or registered trademarks of Ariosa Diagnostics, Inc. in the U.S.A. and other countries. All other trademarks are the property of their respective owners.PP-US-06532-0216