Pleximark™ Tx

Test Code
94636


CPT Codes
81599<br>This test is not available for New York, California, Maryland, or Rhode Island patient testing<br>Restricted Client Code

Preferred Specimen
10 mL whole blood collected in a sodium heparin (green-top) tube


Minimum Volume
7 mL


Instructions

For patients 21 years and older.

Specimen collection and shipping procedure:
1.) Whole blood should be obtained by a trained phlebotomist in a hospital-base or a reference laboratory.

2.) Collect the whole blood in a sodium heparin tube (green top) only. The minimum whole blood volume requirement for Pleximark™ is 7 milliliters (7mL). The optimum whole blood volume is 10 milliliters (10mL). Any sample which is less than 7 mL, Plexision will not perform the test and will immediately notify the physician who ordered the test.

3.) Samples should be drawn between the hours of 5:00am and 10:00 am. This time frame increases the chances that the sample will arrive at Plexision during normal operating hours when staff is available to test it immediately. Sample collection time and date must be noted on the sample label and the Pleximark™ Test Requisition Form or the sample will not be accepted.

4.) After the blood is collected, it should be inverted gently 5 times to ensure mixing with the sodium heparin. Blood samples with clots or broken seals should be discarded.

5.) Plexision will only perform Pleximark™ on sodium heparinized whole blood. Blood sample collected in other anticoagulants will not be accepted for Pleximarks™ testing.

6.) To permit identification of a specimen, the specimen label must have at least two patient identifiers, (e.g., date of birth, patient unique identifier assigned by collection center/hospital, name, etc.).

7.) Complete the Pleximark™ Test Requisition Form (form attached with email). Complete the form by filling in serologic or molecular HLA typing results for donor and patient at HLAA-A, HLA-B, and HLA-DR antigenic loci. Also include patient information for billing along with the doctor ordering the test. Confirm that the patient information on the form matches the information provided on the specimen label.

8.) Fax a copy of the requisition form of Plexision at (412) 224-2776 by 4:00 PM (EST) on the day of the shipment.

9.) Patient blood sample should be shipped to Plexision's laboratory at 4424 Penn Ave. Suite 202, Pittsburgh, PA 15224 via overnight priority shipping (FEDEX, UPS, or other overnight shipping vendor) at ambient temperature and humidity. Package and label the samples in compliance with applicable federal regulation covering the transport of clinical samples and etiological agents. Samples maintained at room temperature for up to 30 hours are acceptable for testing. Blood samples will be tested as soon as possible arrival.

10.) Blood samples will be discarded if the date and time of sample collection is not noted on the requisition form or label, the container shows frozen or clotted blood, if seals are broken, if the sample is collected in tubes other than sodium heparin tubes, sample is unlabeled, sample is received 30 hours after collection period, or the sample is not accompanied by either the test requisition form of HLA.



Transport Temperature
Room temperature


Specimen Stability
Room temperature: 30 hours
Refrigerated: Unacceptable
Frozen: Unacceptable


Methodology
Flow Cytometry

Setup Schedule
Set up: Daily; Report available: Next day


Reference Range
An index of rejection ≥ 1.15 indicates the presence of rejection with a likelihood of 88%. An index of rejection < 1.15 indicates that rejection is absent with a likelihood of 88%


Clinical Significance
Pleximark™ Tx is a functional, cell-based blood test to detect acute cellular rejection after renal transplantation. The test measures the immune response of recipient lymphocytes to the transplant donor. The immune response is measured with T-cytotoxic memory cells which express CD154 (CD154+TcM). Test results are reported as an index of rejection (IR), which expresses this donor-directed immune response relative to the immune response to reference cells.




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.