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APPAN
ANTIPHOSPHOLIPID AB PANEL

Test Code APPAN 
Test ANTIPHOSPHOLIPID AB PANEL 
Methodology Cardiolipin Antibody - Enzyme-Linked Immunosorbent Assay (ELISA)
Beta-2- Glycoprotein 1 Antibodies - Enzyme-Linked Immunosorbent Assay (ELISA)
Lupus Testing - Automated Clot-Based Assays 
Description Useful for the detection of lupus anticoagulant in a patient with a prolonged PTT.

Panel components:
Interpretation
INR
PTT
Silica Screen
Silica Confirmation
DRVVT Screen
Hematocrit (will be performed but not charged)
Cardiolipin Antibodies, IgG and IgM
Beta-2-Glycoprotein 1 Antibodies, IgG, and IgM

If lupus anticoagulant screen is abnormal, the following tests will be performed at an additional charge:

DRVVT Mixing Study
DRVVT Confirm Assay
Silica Mixing Study
PTT using reagent more sensitive to factor deficiencies (Dade Actin FS)
Thrombin Time

NOTE:
This test, when ordered on Medicare patients, is subject to the National Coverage Determination (NCD) policy "Partial Thromboplastin Time (PTT)". Please verify that the diagnosis code (ICD-9) you have chosen demonstrates medical necessity for the test as documented in the physician's patient record. The CMS web site or the NorDx Limited Coverage Documentation Guide are available to assist you with this verification. A properly executed Advance Beneficiary Notice (ABN) must be submitted with the specimen if medical necessity is not demonstrated by the ICD-9 code chosen. 

Specimen Specimens required:

3 Light Blue tops (3.2% sodium citrate)
1 Lavender top (EDTA)
2 Plain Red tops

Process specimens as follows:

BLUE TOP TUBES

1. The blue tops must be spun and the plasma must be separated from the cells within 4 HOURS of collection in a centrifuge at 2,500 rpm for 15 minutes or 3,000 rpm for 10 minutes.
2. Specimens for the LUPUS test must be double spun to obtain the best specimen for testing. See the "COAGULATION DOUBLE SPIN PROCESS" below
3. Using a plastic transfer pipette (do not use a glass pipette) decant the plasma to a screw-capped, plastic (polypropylene) vial. (Glass vials will not be accepted.)
4. Obtain a platelet count on the platelet-poor plasma. If the platelet count is > 10,000, respin the specimen and repeat steps 2 and 3 until the platelet count is < 10,000.
5. Divide the specimen into as many 0.5 - 1.0 mL aliquots as possible and cap the vial(s) tightly.
6. Freeze specimen(s) immediately at <= - 40 C.
7. Send specimen(s) FROZEN on dry ice

LAVENDER TOP TUBE

Mix well, and send a minimum of 1mL of EDTA whole blood refrigerated. (Clotted or grossly hemolyzed specimens are not acceptable.) To be used for a hematocrit that is run at no charge and will be non-reportable. To be tested to rule out abnormal results due to a high hematocrit (> 55%).

RED TOP TUBES

1. Separate the serum from the cells within 4 hours of collection in a cetrifuge at 3,000 rpm for 10 minutes.
2. Using a plastic transfer pipette (do not use a glass pipette) decant the serum to a screw-capped, plastic (polypropylene) vial. (Glass vials will not be accepted.)
3. Freeze specimen(s) immediatley at <= -40 C.
4. Send specimen(s) FROZEN on dry ice.

NOTE:
1. SPECIMENS WILL BE REJECTED IF UNDERFILLED (<90%), CLOTTED, OR GROSSLY HEMOLYZED.
2. If a high hematocrit is detected the client will be contacted to determine the need for a recollect in properly adjusted blue top tubes. A coagulation pathologist will assess this need with the client.
3. 3. Follow "Special Procedure for Drawing Specimen from an A-line".
COAGULATION DOUBLE SPIN PROCESS 

Reference Values An interpretive report will be issued.
INR (0.9 -1.2 seconds)
PTT (24 - 36 seconds)
DRVVT Screen (Negative)
Silica Clot Time Normalized Ratio (less than 1.16)
DRVVT Confirm (Negative)
Dade FS (23 - 29 seconds)
Thrombin Time (11.0 - 15.0 seconds)
Silica Mixing Study (Negative)
DRVVT Mixing Study (Negative) 
Analytic Time 2 Weeks 
Day(s) Test Set Up Once per week 
CPT Code(s) 84285  Silica Mixing Study, if indicated
84285  Silica Screen
84285-90  Silica Confirmation
85610  Prothrombin Time
85613  DRVVT mixing study, if indicated
85613  DRVVT Screen
85613  DRVVT Confirmation, if indicated
85635  Reptilase Time
85670  Thrombin Time, if indicated
85730  PTT with sensitive reagent, (Dade Actin FS),if indicated
85730  Lupus Interpretive Comment
85732  Silica Clot Confirmation Interpretation
86146  Beta-2-Glycoprotein Ab IgG
86146  Beta-2-Glycoprotein Ab, IgM
86147  Cardiolipin Antibodies IgG
86147  Cardiolipin Antibodies IgM

References