Test Code 90521 Cystic Fibrosis Mutation Analysis Panel, 97-Mutation Panel, Integrated Genetics
Performing Laboratory
Integrated Genetics
Methodology
Polymerase Chain Reaction (PCR) Amplification
Specimen Requirements
Submit only 1 of the following specimens:
Blood
Container/Tube: Lavender-top (EDTA) tube
Specimen Volume: 10 mL whole blood for adults, 7mL whole blood for pediatric
Collection Instructions: Invert several times to mix blood. Send specimen at ambient temperature in original VACUTAINER.
Dried Blood Spot
Obtain specimen using a Genzyme Genetics provided filter paper
card (minimum volume: 3 completely filled circles) as
follows:
1. Sterilize, allow skin to dry, and puncture finger with sterile
lancet.
2. Allow large blood droplet to form.
3. Touch filter paper to blood and allow to soak through completely in each circle. Total saturation of circles must be evident when paper is viewed on both sides. Do not apply blood to both sides.
4. Use of capillary tubes is not recommended because they tend to roughen filter paper and cause over absorption.
5. Allow blood spots to air dry thoroughly for 2 to 3 hours at ambient temperature. Keep away from direct sunlight and heat. Do not stack filter papers before they are thoroughly dried. A protective cover may be used to hold specimen while drying.
6. Cover with end flap only after specimen is completely dry.
7. Maintain sterility and forward promptly.
Note: The following are unacceptable specimens:
1. All circles are not completely filled
2. Blood is layered by application on both sides or by multiple spotting
3. Filter paper is scuffed or torn
4. Specimen is contaminated or improperly dried
5. Incomplete information
Reference Values
Reference values are included with patient’s report.
Day(s) Test Set Up
Monday through Sunday
Test Classification and CPT Coding
Test Classification:This test was developed and its performance characteristics determined by Genzyme Genetics in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.
CPT Codes:
81220