ࡱ> _ bjbj 5\5\Ԛ`(::$P" H" .L//(/1. E;1>xԠL0@1LL::/(/ޚ.fffL :R/(/fLff$O"//п|V^s:ۙ <HXWXt/X/?<CfFlWI\??? ^???HLLLLX?????????> : H   CLINICAL IMMUNOLOGY LABORATORY SERVICE MANUAL TABLE OF CONTENTS  TOC \o "1-3" \h \z \u  HYPERLINK \l "_Toc477518657" 1 PROFILE OF DEPARTMENT  PAGEREF _Toc477518657 \h 4  HYPERLINK \l "_Toc477518658" 1.1 Vision Statement  PAGEREF _Toc477518658 \h 4  HYPERLINK \l "_Toc477518659" 1.2 Laboratory Development  PAGEREF _Toc477518659 \h 4  HYPERLINK \l "_Toc477518660" 1.3 Scope  PAGEREF _Toc477518660 \h 4  HYPERLINK \l "_Toc477518661" 1.4 Research and Development  PAGEREF _Toc477518661 \h 4  HYPERLINK \l "_Toc477518662" 1.5 Laboratory Relationships  PAGEREF _Toc477518662 \h 4  HYPERLINK \l "_Toc477518663" 1.6 Personnel  PAGEREF _Toc477518663 \h 5  HYPERLINK \l "_Toc477518664" 1.7 Training, Education and Development  PAGEREF _Toc477518664 \h 5  HYPERLINK \l "_Toc477518665" 1.8 Quality Assurance Programs  PAGEREF _Toc477518665 \h 5  HYPERLINK \l "_Toc477518666" 2 SPECIMEN COLLECTION AND PREPARATION  PAGEREF _Toc477518666 \h 5  HYPERLINK \l "_Toc477518667" 2.1 Specimen Collection  PAGEREF _Toc477518667 \h 6  HYPERLINK \l "_Toc477518668" 2.2 Specimen Collection Instruction  PAGEREF _Toc477518668 \h 6  HYPERLINK \l "_Toc477518669" 2.3 Specimen Collection Tubes  PAGEREF _Toc477518669 \h 6  HYPERLINK \l "_Toc477518670" 2.4 Handling of Specimen  PAGEREF _Toc477518670 \h 7  HYPERLINK \l "_Toc477518671" 2.5 Laboratory Operating Hours  PAGEREF _Toc477518671 \h 9  HYPERLINK \l "_Toc477518672" 2.6 Request Forms  PAGEREF _Toc477518672 \h 9  HYPERLINK \l "_Toc477518673" 3 ENQUIRIES, CONSULTATIONS AND CANCELLATIONS  PAGEREF _Toc477518673 \h 10  HYPERLINK \l "_Toc477518674" 3.1 Enquiries  PAGEREF _Toc477518674 \h 10  HYPERLINK \l "_Toc477518675" 3.2 Clinical Consultation  PAGEREF _Toc477518675 \h 10  HYPERLINK \l "_Toc477518676" 3.3 Paper Reports  PAGEREF _Toc477518676 \h 10  HYPERLINK \l "_Toc477518677" 3.4 Test Result Call-Backs  PAGEREF _Toc477518677 \h 10  HYPERLINK \l "_Toc477518678" 3.5 Test Cancellation  PAGEREF _Toc477518678 \h 10  HYPERLINK \l "_Toc477518679" 3.6 Corporate Clients  PAGEREF _Toc477518679 \h 10  HYPERLINK \l "_Toc477518680" 3.7 Internal Clients  PAGEREF _Toc477518680 \h 11  HYPERLINK \l "_Toc477518681" 4 LIST OF TESTS PERFORMED IN CIL  PAGEREF _Toc477518681 \h 11  HYPERLINK \l "_Toc477518682" 4.1 Connective Tissue Disease and APS Markers  PAGEREF _Toc477518682 \h 11  HYPERLINK \l "_Toc477518683" 4.1.1 Anti-Nuclear Antibody (ANA)  PAGEREF _Toc477518683 \h 11  HYPERLINK \l "_Toc477518684" 4.1.2 Anti-double stranded DNA Antibody (dsDNA)  PAGEREF _Toc477518684 \h 11  HYPERLINK \l "_Toc477518685" 4.1.3 Anti-SSA (Ro) Antibody (SSA or Ro)  PAGEREF _Toc477518685 \h 11  HYPERLINK \l "_Toc477518686" 4.1.4 Anti-SSB (La) Antibody (SSB or La)  PAGEREF _Toc477518686 \h 12  HYPERLINK \l "_Toc477518687" 4.1.5 Anti-Smith Antibody (Sm)  PAGEREF _Toc477518687 \h 12  HYPERLINK \l "_Toc477518688" 4.1.6 Anti-Ribonucleoprotein Antibody (nRNP)  PAGEREF _Toc477518688 \h 12  HYPERLINK \l "_Toc477518689" 4.1.7 Anti-Scl-70 Antibody (Scl-70)  PAGEREF _Toc477518689 \h 12  HYPERLINK \l "_Toc477518690" 4.1.8 Anti-Jo-1 Antibody (Jo-1)  PAGEREF _Toc477518690 \h 12  HYPERLINK \l "_Toc477518691" 4.1.9 Anti-Cardiolipin IgG Antibody (ACA-IgG)  PAGEREF _Toc477518691 \h 13  HYPERLINK \l "_Toc477518692" 4.1.10 Anti-Cardiolipin IgM Antibody (ACA-IgM)  PAGEREF _Toc477518692 \h 13  HYPERLINK \l "_Toc477518693" 4.1.11 Anti-(2-Glycoprotein-1 (Anti-(2GP1) IgG  PAGEREF _Toc477518693 \h 13  HYPERLINK \l "_Toc477518694" 4.1.12 Myositis Panel (16 Antigens)  PAGEREF _Toc477518694 \h 13  HYPERLINK \l "_Toc477518695" 4.1.13 Systemic Sclerosis Panel (13 Antigens)  PAGEREF _Toc477518695 \h 13  HYPERLINK \l "_Toc477518696" 4.1.14 Anti-HMGCR Antibody  PAGEREF _Toc477518696 \h 14  HYPERLINK \l "_Toc477518697" 4.1.15 Anti-cN1A Antibody  PAGEREF _Toc477518697 \h 14  HYPERLINK \l "_Toc477518698" 4.2 Arthritis Markers  PAGEREF _Toc477518698 \h 14  HYPERLINK \l "_Toc477518699" 4.2.1 Rheumatoid Factor (RF) IgM  PAGEREF _Toc477518699 \h 14  HYPERLINK \l "_Toc477518700" 4.2.2 Anti-CCP (Cyclic Citrullinated Peptide)  PAGEREF _Toc477518700 \h 14  HYPERLINK \l "_Toc477518701" 4.3 Syphilis Serology  PAGEREF _Toc477518701 \h 15  HYPERLINK \l "_Toc477518702" 4.3.1 Rapid Plasma Reagin (RPR)  PAGEREF _Toc477518702 \h 15  HYPERLINK \l "_Toc477518703" 4.3.2 Syphilis IgG Antibody  PAGEREF _Toc477518703 \h 15  HYPERLINK \l "_Toc477518704" 4.4 Organ Specific Autoimmunity  PAGEREF _Toc477518704 \h 15  HYPERLINK \l "_Toc477518705" 4.4.1 Anti-Thyroglobulin Antibody (ATG)  PAGEREF _Toc477518705 \h 15  HYPERLINK \l "_Toc477518706" 4.4.2 Anti-Thyroid Peroxidase Antibody (TPO)  PAGEREF _Toc477518706 \h 15  HYPERLINK \l "_Toc477518707" 4.4.3 Anti-TSH Receptor Antibody (TRAB)  PAGEREF _Toc477518707 \h 15  HYPERLINK \l "_Toc477518708" 4.4.4 Anti-Smooth Muscle Antibody (SMA)  PAGEREF _Toc477518708 \h 16  HYPERLINK \l "_Toc477518709" 4.4.5 Anti-Mitochondrial Antibody (AMA)  PAGEREF _Toc477518709 \h 17  HYPERLINK \l "_Toc477518710" 4.4.6 Anti-Liver, Kidney Microsomal Antibody (LKM)  PAGEREF _Toc477518710 \h 17  HYPERLINK \l "_Toc477518711" 4.4.7 Anti-Islet Cell Antibody (ICA)  PAGEREF _Toc477518711 \h 17  HYPERLINK \l "_Toc477518712" 4.4.8 Glutamic Acid Decarboxylase Autoantibody (GAD)  PAGEREF _Toc477518712 \h 17  HYPERLINK \l "_Toc477518713" 4.4.9 Anti-Parietal Cell Antibody (PCA)  PAGEREF _Toc477518713 \h 17  HYPERLINK \l "_Toc477518714" 4.4.10 Anti-Intrinsic Factor Antibody (AIF)  PAGEREF _Toc477518714 \h 18  HYPERLINK \l "_Toc477518715" 4.4.11 Anti-Skeletal Muscle Antibody (SKA)  PAGEREF _Toc477518715 \h 18  HYPERLINK \l "_Toc477518716" 4.4.12 Anti-Glomerular Basement Membrane Antibody (GBM)  PAGEREF _Toc477518716 \h 18  HYPERLINK \l "_Toc477518717" 4.4.13 Anti-Endomysial Antibody, IgA (EMA)  PAGEREF _Toc477518717 \h 18  HYPERLINK \l "_Toc477518718" 4.4.14 Anti-Tissue Transglutaminase Antibody, IgA (TTGA)  PAGEREF _Toc477518718 \h 18  HYPERLINK \l "_Toc477518719" 4.4.15 Anti-Tissue Transglutaminase Antibody, IgG (TTGG)  PAGEREF _Toc477518719 \h 19  HYPERLINK \l "_Toc477518720" 4.4.16 Anti-Gliadin Peptides Antibody, IgA (GLPA)  PAGEREF _Toc477518720 \h 19  HYPERLINK \l "_Toc477518721" 4.4.17 Anti-Gliadin Peptides Antibody, IgG (GLPG)  PAGEREF _Toc477518721 \h 19  HYPERLINK \l "_Toc477518722" 4.4.18 Anti-Phospholipase A2 Receptor (PLA2R)  PAGEREF _Toc477518722 \h 19  HYPERLINK \l "_Toc477518723" 4.5 Vasculitis Markers  PAGEREF _Toc477518723 \h 20  HYPERLINK \l "_Toc477518724" 4.5.1 Anti-Neutrophil Cytoplasmic Antibody (ANCA)  PAGEREF _Toc477518724 \h 20  HYPERLINK \l "_Toc477518725" 4.5.2 Anti-Myeloperoxidase Antibody (MPO)  PAGEREF _Toc477518725 \h 20  HYPERLINK \l "_Toc477518726" 4.5.3 Anti-Proteinase 3 Antibody (PR3)  PAGEREF _Toc477518726 \h 20  HYPERLINK \l "_Toc477518727" 4.6 Genotyping  PAGEREF _Toc477518727 \h 21  HYPERLINK \l "_Toc477518728" 4.6.1 Human Leucocyte Antigen B27 (HLA B27)  PAGEREF _Toc477518728 \h 21  HYPERLINK \l "_Toc477518729" 4.6.2 Human Leucocyte Antigen B57:01 (HLA-B*57:01)  PAGEREF _Toc477518729 \h 21  HYPERLINK \l "_Toc477518730" 4.6.3 Human Leucocyte Antigen B58:01 (HLA-B*58:01)  PAGEREF _Toc477518730 \h 21  HYPERLINK \l "_Toc477518731" 4.7 Allergy Tests  PAGEREF _Toc477518731 \h 22  HYPERLINK \l "_Toc477518732" 4.7.1 Total IgE, Serum  PAGEREF _Toc477518732 \h 22  HYPERLINK \l "_Toc477518733" 4.7.2 Tryptase, Serum  PAGEREF _Toc477518733 \h 22  HYPERLINK \l "_Toc477518734" 4.7.3 Specific IgE Testing  PAGEREF _Toc477518734 \h 23  HYPERLINK \l "_Toc477518735" 5 REFERRED TEST LISTING  PAGEREF _Toc477518735 \h 24  HYPERLINK \l "_Toc477518736" 5.1 C1 Esterase Inhibitor, Functional Assay  PAGEREF _Toc477518736 \h 24  HYPERLINK \l "_Toc477518737" 5.2 C1 Esterase Inhibitor Antigen, Serum  PAGEREF _Toc477518737 \h 24  HYPERLINK \l "_Toc477518738" 5.3 Angiotensin Converting Enzyme, Serum  PAGEREF _Toc477518738 \h 25  HYPERLINK \l "_Toc477518739" 5.4 IgG Subclasses, Serum  PAGEREF _Toc477518739 \h 25  1 PROFILE OF DEPARTMENT 1.1 Vision Statement To be a group of professionals who provide excellent patient care through education and research, supported by a caring work environment. 1.2 Laboratory Development We plan to develop the laboratory into one of choice for clinicians and clinical trialists managing Rheumatologic, Allergic and Immunologic disorders in Singapore and the region. We will offer the complete range of investigations that are performed accurately, reliably, and expeditiously at competitive costs. We plan to make the services of our Laboratory available to new, external clients and to expand the range of investigations we can offer, both by acquiring new equipment and, for the more difficult ones, by engaging the services of other laboratories which can perform them. 1.3 Scope The Clinical Immunology Laboratory (subsequently referred to as CIL in this document) carries out tests that are vital for the management of patients with Rheumatologic, Allergic or Immunologic diseases. 1.4 Research and Development Our laboratory is primarily meant for service work, but does engage in limited volume of research. We constantly look into our in-house tests, like the analysis for HLA-B27, to improve them. We assist in the collection of sera, plasma and genomic DNA for studies. Clinical researchers also make use of the CIL as a central laboratory for analyzing their study specimen samples. 1.5 Laboratory Relationships We work very closely and constructively with the Department of Laboratory Medicine (DLM) in our hospital. We have links with the Immunology Laboratory of the Singapore General Hospital especially in terms of exchanging specimen for mutual corroboration. Certain tests that are neither available in our laboratory nor offered elsewhere in Singapore are sent to the Mayo Medical Laboratories (Rochester, Minnesota) for analysis. 1.6 Personnel Laboratory Director: Dr Leong Khai Pang Deputy Laboratory Director: Dr Tan Teck Choon Medical Technologists In-charge: Carol Ng 1.7 Training, Education and Development Training and education is essential for the maintenance and improvement of our services. Therefore, this program is emphasized in the CIL. New staffs undergo structured training in the different sections of our laboratory so that they gain competence in all the tests. Staffs are granted time to attend courses and talks. 1.8 Quality Assurance Programs The quality of our results is under constant surveillance. Results that vary from the expected range with respect to patient population or laboratory norm will be scrutinized and repeated if necessary. We subscribe to two external audit programs: the National External Quality Assurance Scheme (NEQAS) from UK and College of American Pathologists (CAP) Survey from the USA. Our laboratory has been accredited by the CAP since 2001. 2 SPECIMEN COLLECTION AND PREPARATION Laboratory test results are dependent on the quality of the submitted specimen. It is important that all specimens and request forms be properly labeled with the patients name, collection date, and the origin (source) of the specimen, when applicable. Also, they must be collected in the right manner, transported in the correct tubes and stored in the right conditions. These pre-analytic conditions are vital to the analysis work carried out in the laboratory. If there is doubt or question about the type and method of specimen collection, please contact CIL by telephone (6357-8464) or email to  HYPERLINK "mailto:CIL_Enquiry@ttsh.com.sg" CIL_Enquiry@ttsh.com.sg and we will be happy to assist. 2.1 Specimen Collection Most laboratory tests are performed on serum, plasma or anti-coagulated whole blood. In general, tubes containing the specimens should be refrigerated until they are ready to be transported to the laboratory in the infectious disease biohazard bags. Please see our individual test directory section for other specific requirements. 2.1.1 Plasma Draw a sufficient amount of blood with the indicated anticoagulant to yield the necessary plasma volume. Gently mix the blood collection tube by inverting six to ten times immediately after collection. Ideally, plasma should be separated from cells by centrifugation within 20-30 minutes. 2.1.2 Serum Draw a sufficient amount of blood to yield the necessary serum volume. Allow blood to clot at room temperature. Separate serum from clot by centrifugation within 20-30 minutes. Haemolysis should be avoided. Vigorous mixing, inadequate clotting time for the specimen and high centrifugation speed may cause haemolysis. 2.1.3 Whole Blood Draw a sufficient amount of blood with the indicated anticoagulant. Gently mix the blood collection tube by inverting six to ten times immediately after draw. 2.2 Specimen Collection Instruction When collecting specimens for transportation to CIL, please keep in mind: The specimen must be properly identified. The patient's name, hospital number or the unique identifier must be clearly written on the specimen container. The appropriate test requisition, complete with the patient's name or unique identifier must accompany the specimen. Unlabelled or mislabelled specimens will not be tested. 2.3 Specimen Collection Tubes These tubes are often used to collect specimen for processing in the CIL: Lavender-Top Tube (EDTA) This tube contains the anticoagulant EDTA and is used for collecting whole blood. In CIL, HLA-B27, HLA-B*57:01 and HLA-B*58:01 testing requires whole blood collected with this tube. After filling the tube with blood, immediately invert it several times in order to prevent coagulation. 2.3.2 Light-Blue-Top Tube (Sodium Citrate) This tube contains sodium citrate as an anticoagulant and is used for collecting whole blood. In CIL, HLA-B27, HLA-B*57:01 and HLA-B*58:01 testing requires whole blood collected with this tube. Immediately after blood draw, invert the tube six to ten times in order to activate the anticoagulant. 2.3.3 Serum Separator Tube (SST( - Yellow-Top VACUTAINER() This tube contains a clot activator and serum gel separator used for various laboratory tests on sera. Invert the tube to activate the clotting; let stand for 20-30 minutes before centrifuging for 15 minutes. If frozen serum is required, pour off serum into plastic vial and freeze. Do not freeze VACUTAINER( tubes. 2.4 Handling of Specimen All specimens must be placed in properly labelled containers and transported in an infectious disease biohazard bag. Specimen may be hand-delivered to CIL. 2.4.1 Courier Services Courier services are available for transporting specimens to CIL from many locations throughout Singapore. Special courier services will be established if appropriate arrangements can be made. For more information, please contact us at the following numbers: Tel: 6357-8464 Fax: 6357-8463 Email: cil_enquiry@ttsh.com.sg 2.4.2 Turnaround time This catalog lists the days on which the tests are set up and the amount of time needed to analyse the test sample as an indicator of the turnaround times. Kindly note that repeated tests requires additional time. If the published turnaround times cannot be met by the laboratory, a memo will be send out stating when the result(s) will be available. The results obtained through telephone (6357-8464) are provisional and may change after final quality assurance validation. Only the hard copy printed on letterhead paper issued by CIL should be regarded as final. 2.4.3 Repeat determinations We will repeat tests without additional charge to the patient under the following circumstances: When we determine that our analytical system has failed quality control; If a specimen is lost because of a laboratory accident; or When the result does not correlate (in the doctors opinion) with the patients clinical picture. In such an instance, the doctor should explain the circumstances on the memo accompanying the new specimen. Follow-up or confirmatory testing is not considered repeat determinations and the lab will charge the patient accordingly. 2.4.4 Storage of specimen Original blood specimens and sera are kept at 4oC for a week, and analyzed sera are kept at -70(C for 6 months. There might be occasions when it would be necessary to repeat or run additional tests on those samples in storage. To request this, please send an official requisition form with patients particulars and the date of blood collected. 2.4.5 Unacceptable specimen Some specimens cannot be analyzed because of improper collection or degradation in transit. Other specimens may have prolonged turnaround times because of lack of necessary ancillary specimens or patient information. You will be notified of rejected or problem specimens upon receipt. To avoid specimen rejection, please use the following checklist: Are the patient information boxes in the request form correctly, legibly and adequately filled up? Has the patient been properly prepared before blood draw? For example, the assays for C1 esterase inhibitor (both antigen and functional) level prefers (but not required) fasting blood. Is the specimen derived from the correct patient? Is the specimen kept in the right container (metal-free, separation gel, sterility, etc)? Has the correct specimen type (plasma, serum, whole blood etc) been collected? Is the specimen volume sufficient? Is the storage temperature (ambient, frozen or refrigerated) appropriate? 2.4.6 Labelling errors In the case of a major labelling error (e.g. no label, patient data on specimen container does not tally with request form), the laboratory will notify the doctor or the nurse in-charge and the specimen will be discarded and request rejected. 2.4.7 Specimen rejection policy The quality and appropriateness of the specimen limit accuracy and clinical usefulness of all laboratory analyses. The techniques used for the collection and submission of the specimen can influence the outcome of testing results. All specimens are subject to rejection if: Are of insufficient quantity or quality. Are of excessive age for the type of examination requested. Are received with either specimen container unlabeled or incomplete test request form or the specimen label not matching the test request form. Are leaking and can easily be replaced by recollection. Are of incorrect specimen type or condition 2.5 Laboratory Operating Hours The Laboratory is open as follows: Monday to Friday : 8.30 am 5.30 pm Saturdays, Sundays & Public Holidays : Closed Request Forms Request forms can be downloaded from  HYPERLINK "https://www.ttsh.com.sg/clinical-immunology-lab/" https://www.ttsh.com.sg/clinical-immunology-lab/ for your ease of use. Hardcopy can be supplied without charge. Please call us at 6357-8464 to arrange for delivery of forms. 3 ENQUIRIES, CONSULTATIONS AND CANCELLATIONS 3.1 Enquiries The Medical Technologists of CIL provide technical information; handle general inquiries regarding types of available tests, service hours, and types of supplies available, specimen collection, unacceptable specimens, test results, payment and others. Telephone: 6357-8464 Facsimile: 6357-8463 Email: cil_enquiry@ttsh.com.sg 3.2 Clinical Consultation We welcome clinical discussions on the interpretation of tests conducted in the CIL. Requests for interpretation of test results and consultations should be directed to the laboratory consultant: Dr. Leong Khai Pang Telephone: 6357-7821 Mobile no: 8126-3240 Dr. Tan Teck Choon Mobile no: 9117-7858 3.3 Paper Reports Reports will be sent to the requesting location. 3.4 Test Result Call-Backs Results will be faxed (or emailed to requesting doctor) to a client when requested. 3.5 Test Cancellation Physicians occasionally decide that certain tests are not needed after the specimen drawn from the patient has been dispatched. We honour such cancellations at no charge provided the tests have not been set up. Once the analysis has commenced, such requests cannot be accepted. A memorandum containing the patients particulars test(s) to be cancelled and doctors signature must be sent to CIL within 24 hours after verbal cancellation. 3.6 Corporate Clients The Finance Department will issue a monthly billing invoice for tests performed in the Laboratory to private medical practitioners, contractual clients and private institutions allied to TTSH. Internal Clients Doctors practicing in Tan Tock Seng Hospital utilize a different system for test ordering and obtaining patient reports. 4 LIST OF TESTS PERFORMED IN CIL This is a list of tests currently performed in the CIL. Electronic version can be found on TTSH website:  HYPERLINK "http://www.ttsh.com.sg/Clinical-Immunology-Lab/" http://www.ttsh.com.sg/Clinical-Immunology-Lab/ 4.1 Connective Tissue Disease and APS Markers Anti-Nuclear Antibody (ANA) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Indirect Immunofluorescence Reference: Normal <80 Titre If positive, results are titred up to 1/640 dilution and patterns indicated. Turnaround Time: 1-4 days Day(s) Test Set Up: Monday through Friday, Morning Anti-double stranded DNA Antibody (dsDNA) Specimen Required: Serum (Yellow or Red top) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal < 25 IU/mL Turnaround Time: 1-2 days Day(s) Test Set Up: Monday through Friday, Morning Anti-SSA (Ro) Antibody (SSA or Ro) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal <20 RU/mL Turnaround Time: 1-7 days Day(s) Test Set Up: Friday, Morning Anti-SSB (La) Antibody (SSB or La) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal <20 RU/mL Turnaround Time: 1-7 days Day(s) Test Set Up: Friday, Morning Anti-Smith Antibody (Sm) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal <20 RU/mL Turnaround Time: 1-7 days Day(s) Test Set Up: Friday, Morning Anti-Ribonucleoprotein Antibody (nRNP) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal <20 RU/mL Turnaround Time: 1-7 days Day(s) Test Set Up: Friday, Morning Anti-Scl-70 Antibody (Scl-70) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal <20 RU/mL Turnaround Time: 1-7 days Day(s) Test Set Up: Friday, Morning Anti-Jo-1 Antibody (Jo-1) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal <20 RU/mL Turnaround Time: 1-7 days Day(s) Test Set Up: Friday, Morning Anti-Cardiolipin IgG Antibody (ACA-IgG) Specimen Required: Serum (Yellow or Red top) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal d"20 GPL Units Turnaround Time: 1-7 days Day(s) Test Set Up: Tuesday, Morning Anti-Cardiolipin IgM Antibody (ACA-IgM) Specimen Required: Serum (Yellow or Red top) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal d"20 MPL Units Turnaround Time: 1-7 days Day(s) Test Set Up: Tuesday, Morning Anti-(2-Glycoprotein-1 (Anti-(2GP1) IgG Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal <20 RU/mL Turnaround Time: 1-7 days Day(s) Test Set Up: Tuesday, Morning Myositis Panel (16 Antigens) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Immunoblotting Assay Reference: Negative (Reported as Strong Positive, Positive or Negative) Individual results for 16 Antigens: Mi-2, Mi-2, TIF1, MDA5, NXP2, SAE1, Ku, Ro-52, PM-Scl100, PM-Scl75, Jo-1, SRP, PL-7, PL-12, EJ, OJ Turnaround Time: 1-7 days Day(s) Test Set Up: Monday, Morning Systemic Sclerosis Panel (13 Antigens) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Immunoblotting Assay Reference: Negative (Reported as Strong Positive, Positive or Negative) Individual results for 13 Antigens: Scl-70, CENP A, CENP B, RP11, RP155, Fibrillarin, NOR90, Th/To, PM-Scl100, PM-Scl75, Ku, PDGFR, Ro-52 Turnaround Time: 1-7 days Day(s) Test Set Up: Monday, Morning Anti-HMGCR Antibody Specimen Required: Serum (Yellow or Red top) Transport condition: Refrigerated (2-8oC if <48 hours) Frozen (if >48 hours) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal <20 RU/mL Turnaround Time: 1-7 days Day(s) Test Set Up: Thursday, Afternoon Anti-cN1A Antibody Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal <20 RU/mL Turnaround Time: 1-7 days Day(s) Test Set Up: Wednesday, Morning Arthritis Markers Rheumatoid Factor (RF) IgM Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal <20 RU/mL Turnaround Time: 1-4 days Day(s) Test Set Up: Tuesday and Friday, Morning Anti-CCP (Cyclic Citrullinated Peptide) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal <20 Units Turnaround Time: 1-4 days Day(s) Test Set Up: Monday Morning and Thursday, Afternoon Syphilis Serology Rapid Plasma Reagin (RPR) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA or Heparin) Method: Card Particle Agglutination Test Reference: Non-reactive If reactive, results are titred up to extinction Turnaround Time: 1-3 days Day(s) Test Set Up: Monday through Friday Afternoon Syphilis IgG Antibody Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: <16 RU/mL - Negative e"16 to <22 RU/mL - Borderline e"22 RU/mL - Positive Turnaround Time: 1-4 days Day(s) Test Set Up: Tuesday and Friday, Afternoon Organ Specific Autoimmunity Anti-Thyroglobulin Antibody (ATG) Specimen Required: Serum (Yellow or Red top) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal <100 IU/ml Turnaround Time: 1-7 days Day(s) Test Set Up: Wednesday, Morning Anti-Thyroid Peroxidase Antibody (TPO) Specimen Required: Serum (Yellow or Red top) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal <50 IU/mL Turnaround Time: 1-7 days Day(s) Test Set Up: Wednesday, Morning Anti-TSH Receptor Antibody (TRAB) Specimen Required: Serum (Yellow or Red top) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal <1.0 IU/L Turnaround Time: 1-7 days Day(s) Test Set Up: Wednesday, Morning Anti-Smooth Muscle Antibody (SMA) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Indirect Immunofluorescence Reference: Negative If positive, results are titred up to 1/320 dilution. Turnaround Time: 1-5 days Day(s) Test Set Up: Tuesday and Friday, Morning 4.4.5 Anti-Mitochondrial Antibody (AMA) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Indirect Immunofluorescence Reference: Negative (Reported as Positive or Negative) Turnaround Time: 1-5 days Day(s) Test Set Up: Tuesday and Friday, Morning Anti-Liver, Kidney Microsomal Antibody (LKM) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Indirect Immunofluorescence Reference: Negative (Reported as Positive or Negative) Turnaround Time: 1-5 days Day(s) Test Set Up: Tuesday and Friday, Morning Anti-Islet Cell Antibody (ICA) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Indirect Immunofluorescence Reference: Negative (Reported as Positive or Negative) Turnaround Time: 1-5 days Day(s) Test Set Up: Tuesday and Thursday, Afternoon Glutamic Acid Decarboxylase Autoantibody (GAD) Specimen Required: Serum (Yellow or Red top) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal <5 U/mL Turnaround Time: 1-14 days Day(s) Test Set Up: Alternate Monday, Morning Anti-Parietal Cell Antibody (PCA) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Indirect Immunofluorescence Reference: Negative (Reported as Positive or Negative) Turnaround Time: 1-5 days Day(s) Test Set Up: Tuesday and Friday, Morning Anti-Intrinsic Factor Antibody (AIF) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal <20 RU/mL Turnaround Time: 1-7 days Day(s) Test Set Up: Thursday, Morning Anti-Skeletal Muscle Antibody (SKA) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Indirect Immunofluorescence Reference: Negative (Reported as Positive or Negative) Turnaround Time: 1-5 days Day(s) Test Set Up: Tuesday and Friday, Morning Anti-Glomerular Basement Membrane Antibody (GBM) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Indirect Immunofluorescence Reference: Negative (Reported as Positive or Negative) Turnaround Time: 1-3 days Day(s) Test Set Up: Monday through Friday Anti-Endomysial Antibody, IgA (EMA) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Indirect Immunofluorescence Reference: Negative (Reported as Positive or Negative) Turnaround Time: 1-5 days Day(s) Test Set Up: Tuesday and Friday, Morning Anti-Tissue Transglutaminase Antibody, IgA (TTGA) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal <20 RU/mL Turnaround Time: 1-7 days Day(s) Test Set Up: Thursday, Morning Anti-Tissue Transglutaminase Antibody, IgG (TTGG) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: <1.0 Ratio Negative e"1.0 to 2.0 Ratio  Weak Positive e"2.0 to 5.0 Ratio  Positive e"5.0  High Positive Turnaround Time: 1-7 days Day(s) Test Set Up: Thursday, Morning Anti-Gliadin Peptides Antibody, IgA (GLPA) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal <25 RU/mL Turnaround Time: 1-7 days Day(s) Test Set Up: Thursday, Morning Anti-Gliadin Peptides Antibody, IgG (GLPG) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal <25 RU/mL Turnaround Time : 1-7 days Day(s) Test Set Up: Thursday, Morning Anti-Phospholipase A2 Receptor (PLA2R) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: <14 RU/mL  Negative e"14 to <20 RU/mL  Borderline e"20 RU/mL  Positive Turnaround Time: 1-7 days Day(s) Test Set Up: Thursday, Morning Vasculitis Markers Anti-Neutrophil Cytoplasmic Antibody (ANCA) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Indirect Immunofluorescence Reference: Negative If positive for C-ANCA or P-ANCA, the result will be reported. Anti-Myeloperoxidase Antibody (MPO) & Anti-Proteinase 3 (PR3) antibody will be recommended. Anti-MPO & Anti-PR3 will be quantitated by enzyme-linked immunosorbent assay (ELISA). There will be additional charges for these tests. NOTE: Not all specimens positive for P-ANCA are positive for Anti-MPO and not all specimens positive for C-ANCA are positive for Anti-PR3 antibody. Turnaround Time: 1-5 days Day(s) Test Set Up: Tuesday and Friday, Morning Anti-Myeloperoxidase Antibody (MPO) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal <20 RU/ml Turnaround Time: 1-7 days Day(s) Test Set Up: Monday, Morning Anti-Proteinase 3 Antibody (PR3) Specimen Required: Serum (Yellow or Red top) or plasma (EDTA, Heparin or Citrate tube) Method: Enzyme Linked Immunosorbent Assay (ELISA) Reference: Normal <20 RU/ml Turnaround Time: 1-7 days Day(s) Test Set Up: Monday, Morning Genotyping Human Leucocyte Antigen B27 (HLA B27) Specimen Required: 3 ml Sodium Citrated blood (Light Blue-Top) Method: Polymerase Chain Reaction (PCR) Using Sequence-Specific Primers Reference: Negative (Reported as Positive or Negative) Turnaround Time: 1-7 days Day(s) Test Set Up: Monday, Morning Human Leucocyte Antigen B57:01 (HLA-B*57:01) Specimen Required: 3 ml Sodium Citrated blood (Light Blue-Top) Method: Real-time PCR using gene specific primer pair Reference: Negative (Reported as Positive or Negative) Turnaround Time: 1-7 days Day(s) Test Set Up: Thursday, Morning Human Leucocyte Antigen B58:01 (HLA-B*58:01) Specimen Required: 3 ml Sodium Citrated blood (Light Blue-Top) Method: Real-time PCR using gene specific primer pair Reference: Negative (Reported as Positive or Negative) Turnaround Time: 1-7 days Day(s) Test Set Up: Friday, Morning Allergy Tests Total IgE, Serum Specimen Required: Serum (Yellow or Red top) or plasma (EDTA or Heparin tube) Method: Fluorescent Enzyme Immunoassay (FEIA) using ImmunoCap 100 system Reference: Normal <113 kU/L (for Adult and children age > 10 years old) Children Age (up to)Reference Range (kU/L) (Geometric Mean + 2SD)6 weeks<4.03 mths<7.26 mths<12.89 mths<17.412 mths<22.82 years<40.33 years<564 years<705 years<846 years<987 years<1108 years<1249 years<13610 years<148Turnaround Time: 1-7 days Day(s) Test Set Up: Wednesday, Morning Tryptase, Serum Specimen Required: Serum (Yellow or Red top) or plasma (EDTA or Heparin tube). NOTE: Samples should preferably be taken between 15 minutes and 3 hours after the suspected event causing mast cell activation. Method: Fluorescent Enzyme Immunoassay (FEIA) using ImmunoCap 100 system Reference: Normal < 11.4 g/L (for children >4 years and adults) Turnaround Time: 1-7 days Day(s) Test Set Up: Wednesday, Morning Specific IgE Testing Allergens available: DrugsPenicilloyl GPenicilloyl VAmoxicilloylAmpicilloyl EnvironmentalD. pteronyssinus (House dust mite)D. farinae (House dust mite)Blomia tropicalis (House dust mite)Cockroach Dog DanderCat dander Aspergillus fumigatusInsect VenomHoney BeePaper WaspYellow Jacket (Common Wasp)Yellow HornetWhite-faced HornetComponentsrAra h1 (peanut)Ovomucoid rAra h2 (peanut)OvalbuminrAra h8 (peanut)rTri a 19 Omega-5 GliadinrAra h9 (peanut)Casein (Milk)rCor a14 (Hazelnut)-lactoglobulin (Milk)rAna o3 (Cashew nut)FoodEgg White EggEgg Yolk CoconutCrabShrimpCod FishChickenMilkCheese, CheddarWheatPeanutSoya BeanSesameChick peaPeaBeef RiceMacadamia Nut Corn, MaizePine NutTree Nuts (Almond, Cashew, Pecan, Brazil, Pistachio, Hazel, Walnut) Note: CIL is able to perform tests for allergens not listed here as long as they are available from the manufacturer. Please call 6357-8464 to discuss the availability and price of allergen. The ordering and interpretation of specific IgE tests should be made with careful clinical correlation. They are useful for confirming the allergen specificity in patients with clinically documented allergic disease. They may be less effective when used for screening. Specimen Required: Serum (Yellow or Red top) or plasma (EDTA or Heparin tube) Method: Fluorescent Enzyme Immunoassay (FEIA) using ImmunoCap System Reference: Class Interpretation 0 Negative 1 Equivocal 2 Positive 3 Positive 4 Strongly positive 5 Strongly positive 6 Strongly positive NOTE: Results will also be reported in kU/L Turnaround Time: 1-7 days Day(s) Test Set Up: Wednesday, Morning REFERRED TEST LISTING CIL is the reference lab for all tests sent to Mayo Medical Laboratory in TTSH. Following list some commonly sent tests. 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C1 Esterase Inhibitor, Functional Assay Specimen Required: Serum (Red top only) Fasting (12 hour) Method: Enzyme Immunoassay (EIA) Reference: >67% normal (normal) 41 67% normal (equivocal) <41% normal (abnormal) Turnaround Time: 1-7 days Day(s) Test Send-out: Monday, Wednesday, Friday mornings (Note: Please call lab at 6357-8464 before sending) C1 Esterase Inhibitor Antigen, Serum Specimen Required: Serum (Yellow or Red top) Fasting (12 hour) preferred, but not required. Method: Nephelometry Reference: 19 37 mg/dL Turnaround Time: 1-7 days Day(s) Test Send-out: Monday, Wednesday, Friday mornings Angiotensin Converting Enzyme, Serum Specimen Required: Serum (Yellow or Red top) NOTE: The use of angiotensin-converting enzyme (ACE)inhibiting antihypertensive drugs will cause decreased ACE values. Method: Spectrophotometry (SP) Reference: 8  53 U/L (for adults e"18 years) Turnaround Time: 1-7 days Day(s) Test Send-out: Monday, Wednesday, Friday mornings IgG Subclasses, Serum Specimen Required: Serum (Yellow or Red top) Method: Nephelometry Reference: Reference Range (mg/dL) AgeTOTAL IgGIgG subclass 1IgG subclass 2IgG subclass 3IgG subclass 40 to <5 months100-33456-215d"82 7.6-82.3d"19.85 to <9 months164-588 102-369d"8911.9-74.0d"20.8 9 to <15 months246-904 160-562 24-9817.3-63.7 d"22.015 to <24 months313-1170209-72435-10521.9-55.0 d"23.02 to <4 years295-1156158-72139-17617.0-84.70.4-49.14 to <7 years386-1470 209-90244-31610.8-94.90.8-81.97 to <10 years462-1682 253-101954-4358.5-102.6 1.0-108.710 to <13 years503-1719 2ȣɣ\] k¥åĥGʦ˦ͦ!%Ĩ کܩ *,HJfhªĪҪԪ뭣 h3h?h3h?CJaJh3h?5PJ\h3h?5\h3h?PJh%Nh?5h%Nh?hh#h%Nh?mHsH h%NhFYhh%Nh?5\h h%Nh?Ujh%Nh?U4ĥťG\u˦̦ͦ!^  :کܩ$If@ ^@ @ ^@ gdFY @ ^@ ` & Fܩ,Jh$IfPkd.r$$If;0y"''"62 24a $$Ifa$ĪԪ c]]]]]]$Ifkdr$$If;ֈ ]y"#"62 24a  (*:<JLRTfhrtvxƫȫܫޫ  .0<>RT^`b|~¬ҬԬ֬"$68HJLhj|~ƭȭh3h?CJaJ h3h?h3h?o(h3h?PJW  *<LThvc]]]]]]$Ifkdbs$$If;ֈ ]y""62 24avxȫޫc]]]]]]$Ifkdt$$If;ֈ ]y""62 24a 0>T`c]]]]]]$Ifkdt$$If;ֈ ]y""62 24a`b~¬Ԭc]]]]]]$Ifkdru$$If;ֈ ]y""62 24aԬ֬$8Jc]]]]]]$Ifkd"v$$If;ֈ ]y""62 24aJLj~ȭc]]]]]]$Ifkdv$$If;ֈ ]y""62 24aȭʭ6Jc]]]]]]$Ifkdw$$If;ֈ ]y""62 24aȭʭ46HJLjl|~ *,>@BTVfhvx0124578:;=>ÿÿÿÿjzhRi5@UhMYjhMYU h?hh h%Nh?h3h?o(Uh3h?PJ h3h?h3h?CJaJE80-103066-50211.5-105.3 1.0-121.913 to <16 years509-1580289-93482-51620.0-103.20.7-121.716 to <18 years487-1327283-77298-48631.3-97.60.3-111.0e"18 years767-1590341-894171-63218.4-106.02.4-121.0 Turnaround Time: 1-7 days Day(s) TeJLl~c]]]]]]$Ifkd2x$$If;ֈ ]y""62 24a ,@c]]]]]]$Ifkdx$$If;ֈ ]y""62 24a@BVhxc]]]]]]$Ifkdy$$If;ֈ ]y""62 24a134679:caWaaaaaaa @ ^@ `kdBz$$If;ֈ ]y""62 24a st Send-out: Monday, Wednesday, Friday mornings      Page  PAGE 3 of  NUMPAGES 24  Page  PAGE 21 of  NUMPAGES 24  Tan Tock Seng HOSPITAL :<=?@ABefhijk$a$$a$$a$h]h>?@GHNOPQRUV`acdfghipqwxz{縯縯竟疍竀 h?hhRiCJ,aJ,hRi5CJ,aJ,hRi5CJHaJHjʹhRi5@UhMYh(,mHnHujhRiUj^hRi5@Uh(,0JmHnHu hRi0JjhRi0JUhRihRi5@CJOJQJ hRi5@*w 0&P +p,p-p.p/R!. 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