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Pleximmune™
Test Code94635
CPT Codes
81599<br /> This test is not available for New York, California, Maryland, or Rhode Island patient testing<br /> Limited Access Code
Preferred Specimen
5 mL whole blood collected in sodium heparin (green-top) tube
Minimum Volume
3 mL
Instructions
Please note: For patients less than 21 years old.
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 Pleximmune™ is 3 milliliters (3mL). The optimum whole blood volume is 5 milliliter (5mL). Any sample which is less than 3 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 Pleximmune™ 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 Pleximmune™ on sodium heparinized whole blood. Blood sample collected in other anticoagulants will not be accepted for Pleximmunes™ 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 Pleximmune™ Test Requisition Form accessible on the Plexision web site www.Plexision.com. The Test
Requisition Form is under Pleximmune/Ordering information. 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. 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 after 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.
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 Pleximmune™ is 3 milliliters (3mL). The optimum whole blood volume is 5 milliliter (5mL). Any sample which is less than 3 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 Pleximmune™ 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 Pleximmune™ on sodium heparinized whole blood. Blood sample collected in other anticoagulants will not be accepted for Pleximmunes™ 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 Pleximmune™ Test Requisition Form accessible on the Plexision web site www.Plexision.com. The Test
Requisition Form is under Pleximmune/Ordering information. 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. 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 after 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
For post-transplant blood samples, an IR ≥ 1.1 implies increased risk. An IR < 1.1 implies decreased risk.
For pre-transplant samples, an IR ≥ 1.23 implies increased risk. An IR <1.23 implies decreased risk
For pre-transplant samples, an IR ≥ 1.23 implies increased risk. An IR <1.23 implies decreased risk
Clinical Significance
Pleximmune™ is intended to be performed at a single laboratory to measure the CD154 expression on T-cytotoxic Memory cells (TcM) in patient?s peripheral blood lymphocytes (PBL) isolated from heparinized whole blood (anticoagulant- sodium heparin). Pleximmune™ is a qualitative prognostic test intended to be used in patients less than 21 years old with liver or small bowel transplantation. The Pleximmune™ test is an aid in the evaluation of the risk of acute cellular rejection (ACR) and must be used in conjunction with biopsy, standard clinical assessment and other laboratory information.
