Principles of the Test Procedure The Alere Triage® D-Dimer Test is a single use fluorescence immunoassay device designed to determine the concentration of D-dimer in EDTA anticoagulated whole blood or plasma specimens. 0000065820 00000 n �)�q���Q>���(���?�ƢG��pHu�R�P�m,&`!���N��'�u��9a��S�7��[�,��!.�d=D�"5;#ǷƐl���!)f�m��Hj�~+�UZ��. This test is conducted by simply taking a blood sample from the patient and then analyzing the blood for the presence of the protein in the blood. 0000045719 00000 n d-dimer testing emerged as a useful laboratory tool for the diagnosis of VTE over the last 20 years because it has high negative predictive value when used in combination with pretest clinical probability. A method and test kit to perform a simple detection assay for D-dimer, a fibrin breakdown product, which utilizes purified Fragment E of human fibrinogen attached to a solid phase for direct chemical binding of D-dimer from a biological sample. The Alere Triage D-Dimer Test is a single use fluorescence immunoassay device designed to determine the concentration of D-Dimer in EDTA anticoagulated whole blood or plasma specimens. xref This direct binding method to assay for D-dimer of the present invention can be performed in a number of ways. However, a positive D-dimer test does not tell your doctor where the blood clot was or what caused it. /Prev 336983 /Length 224 Limitations A number of limitations of the use of D-dimer for VTE diagnoses are listed in Table II [4]. 0000001830 00000 n ))c�z�^�%kq���B�I�@�C�4�L�4�N��l-/�x�Sw ���t�������������\B; o��ٕ��3���@Qj�+���V��Z�f��o~��+,ӊ��~K U��}�h��7��!�H��� �,S+������XSژ?r8�m�,�� �S۰�@[��6 ��F5��a�� �yS��(�ǵ���{=�q:�{dY�/���C�=��'��w����c I��4�������Y\C�O����]�o$��z��� 7���r%ַ���TE�Z���c�gۉޒ2����1|ֹ�B����%�C�\��#>�ί����s�#'m�zSr���S��}B����5�u!��šA�+���Ş�6�$ �S��2/�@��҈�.�W��II��=��HG� Radiological procedures and laboratory tests provide important information when assessing patients suspected of VTE. The D-dimer test measures the amount of a protein called “fibrin D-dimer” in the blood.1 Fibrin D-dimer is produced whenever fibrin (a protein that is the chief component of a blood clot), is being actively degraded somewhere within the vascular system. 0000038753 00000 n Objectives: Systemic values of the fibrinolytic plasma marker fibrin D-dimer are raised in a variety of acute clinical conditions. << 0 << • If the color of moisture indicators are changed from yellow to green, please do not use the test device. %PDF-1.5 endobj 0000039423 00000 n 2 0 obj 0000024005 00000 n 154 0 obj If the D-dimer test is positive, objective imaging has to be performed. et al., Am J Clin Pathol . This test is also ordered when an individual shows apparent symptoms od DVT, PE or DIC. <> 0000028911 00000 n D-dimer Before Use After Use CAUTION • Do not write on the bar code or damage the bar code of the test device. To clarify this issue we performed a systematic review of the relevant literature. Introduction: • D-dimer is one of the protein fragments produced when a blood clot gets dissolved in the body. 0000023285 00000 n After addition … mx��CT@�y��o��g�lC��m�Y��[�����No@ D|��~,"v[0MKR.0y�{xAr��c��B����T�jr���}�j�@��|h�Q�4/90l>9�����֛NfnH�N�o��i�����#R�:�0��Z����7��_Œx5ǀ���#@J�.s��耂�����Ȋ�U���.g7(I��S���MVG"q&-X$}���N���~� ���c"�m�|p�A7#�x?�b� Zi��'���S$Wt %PDF-1.7 D dimer test. /PageLayout /SinglePage �49�g��[���F�8Y�X=�n�~S���q=����dj�w��gq0tE�����4t7�¸"-r�\*9q���#m�i]D�+Q�Yt��֩��~@���LˤZM�.���ߓ�D,H�,�,���l���d*ur��;��0e��H�a3��1������qȭ�8�0��tvF�� �6~gkЎ��)ף Pq,;""�؋N��sy3�Z �B5ًI���g��'9�6ِ�;�_zD5x�.�l҂�V6fQ[�e,t�,;"���{�&V��� d��6dX�,+ The control line appears on the membrane of the test device after use. 25 sealed cartridges are packed in a box which also contains an ID chip. 3 0 obj 0000044807 00000 n >> 0000044250 00000 n To enter the calibration on the analyzer, scan the barcode printed on the Assay Value insert across the barcode reader of the instrument. <>>> In particular, the D-dimer test has shown to be extremely valuable in the diagnostic process for VTE. x�c``pd`�d`a`JWe�c@ >6v�8��#L trailer 0000175238 00000 n 0000028278 00000 n 0000003005 00000 n /S 94 87 0 obj /PageMode /UseThumbs A D-Dimer Test is extremely useful in diagnosing deep venous thrombosis or pulmonary embolus, both clotting disorders, in an individual. /Extensions << /ADBE << /BaseVersion /1.7 /ExtensionLevel 3 >> >> D-Dimer is normally undetectable unless the body is forming or breaking down the blood clots and the level of D-Dimer rises in the blood. stream DDITT : Specimen Type: Platelet-poor plasma Collection Container/Tube: Light-blue top (3.2% sodium citrate) Submission Container/Tube: Plastic vial Specimen Volume: 1 mL Collection Instructions: 1. /Filter /FlateDecode /N 2 0000023680 00000 n 0000173903 00000 n /Outlines 81 0 R However, a positive D-dimer test cannot predict whether or not a blood clot is present. /O 89 << 0000152811 00000 n 0000003432 00000 n %���� D-dimer test is a simple blood test. endobj During this test, a lab technician or a phlebotomist will cleanse the area to be injected with an antiseptic and wrap an elastic band around the upper arm to make the vein visible and pool with blood. Introduction: D-dimer is a fibrin degradation product(FDP), a small protein fragment present in the blood after a blood clot it is degraded by fibrinolysis. It involves the activation of a series of circulating proteins (called the coagulation factors, or clotting factors) that eventually pr… 0000006032 00000 n However, a positive D-dimer test cannot predict whether or not a clot is present. startxref A negative D-dimer test (D-dimer level is below a predetermined cut-off threshold) indicates that it is highly unlikely that a thrombus is present. The potential usefulness of d-dimer was first suggested for pulmonary embolism (PE) by Bounameaux et al. The D-dimer levels were acquired from blood samples (reference range, 0.0–0.4 μg/mL). Centrifuge, remove plasma, and centrifuge plasma again. 0000127341 00000 n 88 0 obj P����i`�b'�'M{���^d�� Ē#�)��wfvIQZ���jĒ��og�kg�ߎ����ZHS�F -S)Ū:>��'�8>�>�7o^}<=?�ɉx{v*�yRe�I�T�!} /Linearized 1 >> 2. 0000004981 00000 n 0000155515 00000 n • Some of this increase can be explained by an approximately 6% increase in ED visits during the study period (daily average of 221 before to 235 after implementation). >> 0000158517 00000 n /Metadata 86 0 R The Alere Triage® D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage® Meters for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens. 0000173305 00000 n Best Laboratory in Pune For Reliable And Affordable Pathology Lab Test in Pune And Pimpri Chinchwad. 0000008372 00000 n wrqy�>������Q&n�W~}8>�Wr11��jb1���~U�k�z�oq���w������Sц,Y�2! 0000172876 00000 n /Root 88 0 R /E 175657 /OpenAction 85 0 R 0000007637 00000 n With a careful combination of clinical assessment and D-dimer, VTE can be excluded. << Blood clotting is an extremely complex process. 0000022789 00000 n 0000173777 00000 n /Names 82 0 R D-dimer test threshold for people aged over 50 years should be considered [17, 20]. /H [ 2129 322 ] Your healthcare provider uses a thin needle to extract blood. 0000008693 00000 n Book Online And Get Your Report in Email 0000039099 00000 n A blood sample is merely drawn from your vein. The use of D-dimer assays as a rule-out test for deep venous thrombosis (DVT) is controversial. Calibration Kit reagents are pre-calibrated: this pre-calibration is valid for all the kits of the same lot. D Dimer Blood Test is very useful in people with suspected clots in the leg or heart. Our D-dimer protocol involved a screening D-dimer test on the day of admission (i.e., hospital day 0), followed by D-dimer tests every other day (i.e., hospital days 2, 4, 6) until discharge or day 16. Lewandrowski . 0000165329 00000 n The D-dimer test is done by various methods including the ELISA assay. A D-dimer test is usually performed in case of emergencies when there is a sudden onset symptom of chest pain, breathlessness or weakness in arms or legs. /Size 155 To check the level of D-Dimer in the blood, D-Dimer test is conducted. If the D-dimer is negative, no further investigations are recommended.1,2,5,6 A meta-analysis from 2010 demonstrated a high negative predictive value (NPV) of PE and low mortality in patients, who had a Wells score ≤4 combined with a normal D-dimer test.6 1. A negative D-Dimer test result has a high negative predictive value for patient with a suspected thrombotic disorder. 9/ PROCEDURE 9.1. 0000044839 00000 n 0000003142 00000 n A D-Dimer Test is a form of a blood test which is done to identify any blood clots that may be forming in the vascular system of the body of an individual. 0000173384 00000 n What is the D dimer test procedure? implementation of the rapid D-dimer test to a mean of 154 tests per month (a 21.3% increase; P = 0.037), reflecting increased utilization. D-dimer testing. 0000100022 00000 n A whole-blood D-dimer (SimpliRed; Agen Biomedical Ltd, Brisbane, Australia) test was performed, and residual plasma was frozen and later analyzed using two enzyme-linked immunosorbent assay (ELISA) methods (D-dimer Gold; Agen, and Asserachrome D-Di; Stago International, Parsippany, New Jersey, USA) and the Miniquant D-dimer. fXT���q��@��tѯ� ���W���|���DYLz���(�"`��G��V��0[]@�=�g�"�]۽�F6KeT���9=��a%|-O�^2���g�[G�r��p艁��{��O�%^.���lMd��a�O�x�HF�h��O0������� ��L��� �sa. 0000028479 00000 n '�L��5��J>�:�W}�� 0000029236 00000 n 0000155105 00000 n stream It indicates that further diagnostic procedures are required (e.g., ultrasound, CT angiography). D-dimer values can now be rapidly determined and used to aid diagnosis in emergency medicine. Test procedure. 2009;132:326-331. 0000000017 00000 n When a D‐dimer test with a sensitivity close to 100% is performed, it can be used as a stand‐alone test as a first exclusion step, except in patients with a high clinical suspicion of VTE. 0000045399 00000 n 0000038155 00000 n E��J�ifk1k|�^1� �6�i�Ĭ�D 0000002451 00000 n Dempfle CE, Zips S, Ergul H, Heene DL. 0000038721 00000 n x��[�o��7��a_ 0000028447 00000 n NycoCard D-Dimer measures D-Dimer configurated molecules, which are released into the circulation by the activation of the fibrinolysis system. /ID [] endobj <>/ExtGState<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Less sensitive assays should be used in combination with another diagnostic procedure or only in lower probability patients . D-Dimer test is used in a hospital emergency room setting to determine if the person is at intermediate or low risk for thrombosis or thrombotic embolism. 0000155423 00000 n 0000038554 00000 n 0000173975 00000 n %���� /Type /Catalog mouse monoclonal anti human D-Dimer at the test line, while streptavidin at the control line. 0000173148 00000 n A negative D-dimer test (D-dimer level is below a predetermined cut-off threshold) indicates that it is highly unlikely that a thrombus is present. /Lang (en-US) H��տQ�������U@]d����qQy?q�"d���?�*:�}��{����S��0 0000002129 00000 n endobj 0000004112 00000 n Through this activation, fibrin is degraded by plasmin to various soluble fragments in which the D-Dimer configuration occurs. D Dimer Test Procedure D dimer test does not require any preparation as this can be done at any random time of the day. References. The increase in turbidity corresponds to the concentration of D-dimer in the test specimen. 1 0 obj 0000108079 00000 n The test procedure involves the addition of several drops of an EDTA anticoagulated whole blood or plasma specimen to the sample port on the Test Device. The evaluated D-dimer blood test reference ranges are 0-300 nanograms/milliliter. 0000173036 00000 n ��7��0��y�[�����. 0000158563 00000 n 0000044640 00000 n /Pages 80 0 R 87 68 4 0 obj /T 336994 endobj The test procedure involves the addition of several drops of an EDTA anticoagulated whole blood or plasma specimen to the sample port on the Test Device. 0000175182 00000 n /O 257 D-dimer test performed and a negative test excludes VTE with a high sensitivity. /ViewerPreferences << /Direction /L2R >> 0000027902 00000 n [Test Procedure] • Using a STANDARD F100 Analyzer 1. Analysis of five case studies by the All-Party Parliamentary Thrombosis Group demonstrated that the availability of diagnostic tools, such as the POC D-dimer tests, in primary care led to the redesigning of local community-based DVT pathways [21]. 0000172820 00000 n Because the clinical diagnosis of deep vein thrombosis is unreliable, venous ultrasonography is the test of choice, owing to its high reliability in the diagnosis of proximal thrombosis (8,–,10). 0000003763 00000 n This test should be used with other clinical and diagnostic information in order to diagnose and manage patients. 0000028828 00000 n 0000066412 00000 n 0000005671 00000 n Each cartridge is individually sealed in an aluminum foil pouch containing a desiccant. Symptoms of DVT … ��9����HT/d������I�+�u���ӑ���x���ƻpo�hR�8�gp6��o��_X=E������ҫgAtC��Dz���3Ѥ�q�f�fFQ�����̴B��������K�0�5з�d>q҈Ĭ���kR۹�|I��x�($(�f@������c�!�c� �8�*,K;�VJV���E*��/`f��X����ٛ,{+O;9���%��b�g����$0��Z�޷H������]ў�~�;�Ond���3���DZ���cW�w�#�Xa�]������_ŷ'�%,ָ>xg=�o�"y�}2�IuX|ƕ�����_W*����弔�{Dm�" >> (11), wh… Test Name: D DIMER General Information Lab Order Codes: DDI Synonyms: D-dimer CPT Codes: 85379 –Fibrin degradation products, D-dimer; quantitative Test Includes: Fibrin D-Dimer reported in mg/L FEU. 0000003281 00000 n However, despite clinical guidelines, inappropriate and unnecessary measurement of D-dimer values is a significant clinical problem. 0000155557 00000 n /Info 84 0 R 0000173619 00000 n /L 338861 ��! 0000158221 00000 n Aliquot plasma into plastic vial leaving 0.25 mL in the bottom of centrifuged vial. L�L��N��%��. 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