Clinical Reference Manual

Transcription

1 Clinical Reference Manual February 23, 2018 For the most up-to-date Reference Manual information, please visit our web site at Henry Mall Madison, WI (888)

2 OBTAINING WSLH SERVICE: Setting up an account If you don t already have an account with the WSLH, call our Billing Department (608) or (800) You will be assigned an account number to use when ordering test request forms and kits. Ordering information CLINICAL: Please call our Clinical Supplies Department to order test request forms or test kits (800) Please be prepared to give your assigned account number. Operators are available to take telephone orders Monday through Friday from 8:00 a.m. to 3:00 p.m. or a message can be left at any time. Orders will be processed within three working days. ENVIRONMENTAL or TOXICOLOGY: Please call WSLH Environmental Health Customer Service at (800) Questions or comments? The WSLH strives to provide quality test results and is committed to providing our customers the best possible service. If a result appears inconsistent with clinical findings, or if repeat testing is warranted, please contact us at one of the phone numbers below: WSLH telephone numbers CLINICAL Customer Service - PHONE Clinical Supplies (to order test kits and request forms only) CLINICAL Customer Service - FAX (800) (800) (844) OCCUPATIONAL HEALTH: Please call the Wisconsin Occupational Health Laboratory at (800) WSLH PROFICIENCY TESTING: Please call (800) The WSLH is closed on the following holidays: New Year s Eve Day New Year s Day Martin Luther King Jr. Day Memorial Day Independence Day Labor Day Thanksgiving Day Christmas Eve Day Christmas Day Billing information Tests are billed monthly to the physician s office, hospital, clinic or institution whose account number appears on the test request form accompanying the specimen. ENVIRONMENTAL Customer Service 2601 Agriculture Drive TOXICOLOGY 2601 Agriculture Drive OCCUPATIONAL HEALTH Customer Service 2601 Agriculture Drive FAX Number 2601 Agriculture Drive WSLH PROFICIENCY TESTING Customer Service Billing/Accounts Receivable (800) (608) (800) (608) (800) (800) Full payment is due 30 days from date of invoice. CLIA ID #s: 52D (Cytology, Communicable Diseases, Newborn Screening) Written correspondence may be sent to: (Name of WSLH Department) Wisconsin State Laboratory of Hygiene 465 Henry Mall Madison, WI D (Toxicology) 2

3 Tests by Clinical Area Biochemical Genetics Page 4 Chemical Response Page 19 Communicable Disease Page 22 Cytogenetics Page 137 Cytology Page 303 Newborn Screening Page 321 Kits Page 323 3

4 Biochemical Genetics Acylcarnitine Profile, Quantitative, plasma or serum WSLH Department: Biochemical Genetics (Phone: FAX: ) Recommended Uses: Contraindications: Kit/Container: BG00540 Quantification of 20+ acylcarnitine species and an interpretation of the profile Tandem Mass Spectometry Monday through Friday Within 4 working days after receipt of the specimen, same day if requested Measurement of acylcarnitine species in plasma/serum is important in the diagnosis and clinical management of patients with an organic acidemia or fatty acid oxidation defect. None Minimum 0.5 ml of plasma or serum Serum Separator Tube (red top) or Heparin Tube (green top) Patient Preparation: Preferred green top tube with either Sodium Heparin or Lithium Heparin additive or serum separator tube. Draw 2.5 times the volume requested. Immediately mix the blood by general inversion 5 to 10 times. Separate plasma by centrifugation. Separate serum by allowing blood to clot followed by centrifugation. Transfer the plasma or serum to plastic screw top freezer vial. Freeze the specimen as soon as it is separated from red blood cells. Do not ship frozen plasma or serum in glass tubes. Handling and Transport: Plasma or serum should remain frozen during transport. NOTE: Refrigerated specimens are acceptable provided the time between collection and receipt is less than 24 hours. s sent at ambient temperature s with contamination (blood, bacteria, lipids) Mislabeled specimens Insufficient specimen quantity Requisition Form: Required Information: Biochemical Genetics Requisition Form Laboratory regulations require the following minimum information to be provided on the requisition form for a specimen to be accepted for testing: Patient name or unique identifier; date and time of collection, patient date of birth and sex, specimen type/site of collection, test request(s), clinician name and UPIN, and address for reporting results. Please be certain that name/identifier on the form matches that on the specimen label. Quantification of 20+ acylcarnitine species; Interpretation of profile and clinical significance See result report for recommendations 4

5 Amino Acids (Quantitative), Plasma WSLH Department: Biochemical Genetics (Phone: FAX: ) 506 Recommended Uses: Contraindications: Kit/Container: Quantification for 20+ amino acids HPLC Monday through Friday 2-4 days after receipt of sample, same day if requested Defects in amino acid metabolism may result in the accumulation of one or more amino acid in the blood (aminoacidemia) or excess excretion in urine (aminoaciduria) or both. Errors in amino acid metabolism may lead to such disorders as phenylketonuria (PKU), maple syrup urine disease (MSUD), homocystinuria, glycine encephalopathy and various urea cycle defects. (Note: Many defects in organic acid metabolism also have secondary abnormalities in amino acid levels.) Clinical information is particularly important for appropriate interpretation. None Minimum 1mL plasma Heparin tube (green top) Patient Preparation: Handling and Transport: Preferred green top tube with either Sodium Heparin or Lithium Heparin additive. Draw 2 ½ times the volume requested. Fill the Vaccutainer whenever possible to avoid dilution from the anticoagulant or preservative. Immediately mix the blood by general inversion five to ten times. Separate plasma by centrifugation. Transfer the plasma to plastic screw top freezer vial. Freeze the specimen as soon as it is separated from red blood cells. Do not ship frozen plasma in glass tubes. Blood specimen should be spun down, plasma removed and frozen Plasma should remain frozen during transport Note: refrigerated specimens are acceptable provided the time between collection and receipt is less than 24 hours. s sent at ambient temperature s with contamination (blood, bacteria, lipids) Mislabeled specimens Insufficient specimen quantity Requisition Form: Biochemical Genetics Requisition Form Required Information: Patient Name (unique identifier) Date of Birth Patient Age at collection (day/time of collection) Ordering physician Reason for referral 5

6 Quantification of 20+ amino acids and interpretation of clinical significance See result report for recommendations Additional Comments: Performed: 6

7 Amino Acids (Quantitative), Serum WSLH Department: Biochemical Genetics (Phone: FAX: ) 552 Recommended Uses: Contraindications: Kit/Container: Quantification for 20+ amino acids HPLC Monday through Friday 2-4 days after receipt of sample, same day if requested Defects in amino acid metabolism may results in the accumulation of one or more amino acid in the blood (aminoacidemia) or excess excretion in urine (aminoaciduria) or both. Errors in amino acid metabolism may lead to such disorders as phenylketonuria (PKU), maple syrup urine disease (MSUD), homocystinuria, glycine encephalopathy and various urea cycle defects. (Note: Many defects in organic acid metabolism also have secondary abnormalities in amino acid levels.) Clinical information is particularly important for appropriate interpretation. None Minimum 1 ml Serum 1 ml Serum separator tube (red top) Perform venipuncture as with any other blood collection device and draw 2.5 times the volume requested. Gently invert the tube no more than eight times. Further inversion my cause loss of sample integrity. Do not remove the stopper. Do not centrifuge immediately after collection. Allow the blood to clot at least 30 minutes but no more than 1 hour before centrifugation. Centrifuge the tube. Transfer the serum to a plastic screw top freezer vial for transport to WSLH. Transport to WSLH frozen. Handling and Transport: Serum should remain frozen during transport Note: refrigerated specimens are acceptable provided the time between collection and receipt is less than 24 hours. s sent at ambient temperature s with contamination (blood, bacteria, lipids) Mislabeled specimens Insufficient specimen quantity Requisition Form: Biochemical Genetics Requisition Form Required Information: Patient Name (unique identifier) Date of Birth Patient Age at collection (day/time of collection) Ordering physician Reason for referral Quantification of 20+ amino acids and interpretation of clinical significance See result report for recommendations 7

8 Amino Acids (Quantitative), Urine WSLH Department: Biochemical Genetics (Phone: FAX: ) 553 Recommended Uses: Contraindications: Quantification for 20+ amino acids HPLC Monday through Friday 2-4 days after receipt of sample, same day if requested Defects in amino acid metabolism may results in the accumulation of one or more amino acid in the blood (aminoacidemia) or excess excretion in urine (aminoaciduria) or both. Errors in amino acid metabolism may lead to such disorders as phenylketonuria (PKU), maple syrup urine disease (MSUD), homocystinuria, glycine encephalopathy and various urea cycle defects. (Note: Many defects in organic acid metabolism also have secondary abnormalities in amino acid levels.) Clinical information is particularly important for appropriate interpretation. None Minimum 1mL urine Kit/Container: Patient Preparation: First morning void is ideal Handling and Transport: The normal composition of urine varies during a 24-hour period. Most reference values are based on analysis of first morning voided urine. This specimen is preferred (but not necessary) because it has a more uniform volume and concentration. Avoid dilute urines if possible. To reduce contamination the specimen submitted for analysis should be a clean catch mid stream sample. Urine should remain frozen during transport Note: refrigerated specimens are acceptable provided the time between collection and receipt is less than 24 hours. s sent at ambient temperature s with contamination (blood, bacteria, lipids) Mislabeled specimens Insufficient specimen quantity Requisition Form: Biochemical Genetics Requisition Form Required Information: Patient Name (unique identifier) Date of Birth Patient Age at collection (day/time of collection) Ordering physician Reason for referral Quantification of 20+ amino acids and interpretation of clinical significance See result report for recommendations 8

9 Amino Acids Dietary Screen Quantitative (filter paper) WSLH Department: Biochemical Genetics (Phone: FAX: ) 565 Recommended Uses: Contraindications: Kit/Container: Quantification of 5 amino acids HPLC Monday through Friday 2-4 days after receipt of sample, same day if requested Defects in amino acid metabolism may result in the accumulation of one or more amino acids in the blood (aminoacidemia) or excess excretion in urine (aminoaciduria) or both. Errors in amino acid metabolism may lead to such disorders as phenylketonuria (PKU), maple syrup urine disease (MSUD), homocystinuria, glycine encephalopathy and various urea cycle defects. (Note: Many defects in organic acid metabolism also have secondary abnormalities in amino acid levels.) Clinical information is particularly important for appropriate interpretation. None Whole blood spotted onto filter paper Whatman 904 filter paper Patient Preparation: Handling and Transport: 2 dime-sized dried blood spots collected on provided filter paper. Allow blood specimen to dry for at least 3 hours prior to transport. s should be sent at ambient temperatures. Blood clots Layered blood Incomplete saturation Mislabeling Insufficient specimen quantity Requisition Form: Biochemical Genetics Requisition Form Required Information: Patient Name (unique identifier) Date of Birth Patient Age at collection (day/time of collection) Ordering physician Reason for referral Quantification of 5 amino acids and interpretation of clinical significance See result report for recommendations 9

10 Biotinidase WSLH Department: Biochemical Genetics (Phone: FAX: ) 520 Recommended Uses: Contraindications: Kit/Container: Interpretation of enzyme activity Spectrophotometry Monday through Friday 1 week Biotinidase is an enzyme that frees biotin (vitamin B) from food for use by the body. Symptoms of untreated biotinidase deficiency may appear anytime between 1 week and 10 years of age. Biotinidase deficiency may lead to seizures, delayed development, vision problems, speech problems, respiratory problems, eczema, hearing loss, etc. Proper specimen handling is critical. This is a test for enzyme activity. Exposure to heat, or multiple freeze-thaw cycles can damage the enzyme and lead to a false negative result. None Minimum 1 ml serum Serum Separator Tube (red top) Patient Preparation: Perform venipuncture as with any other blood collection device and draw 2.5 times the volume requested. Gently invert the tube no more than eight times. Further inversion my cause loss of sample integrity. Do not remove the stopper. Do not centrifuge immediately after collection. Allow the blood to clot at least 30 minutes but no more than 1 hour before centrifugation. Centrifuge the tube. Transfer the serum to a plastic screw top freezer vial for transport to WSLH. Transport to WSLH frozen. Handling and Transport: Serum should remain frozen during transport Proper specimen handling is critical. Exposure to heat, or multiple freeze thaw cycles can damage the enzyme and lead to false negative results. s sent at ambient temperature s with contamination (blood, bacteria, lipids) Mislabeled specimens Insufficient specimen quantity Requisition Form: Biochemical Genetics Requisition Form Required Information: Patient Name (unique identifier) Date of Birth Patient Age at collection (day/time of collection) Ordering physician Reason for referral Interpretation of clinical significance 10

11 See result report for recommendations Additional Comments: 11

12 Carnitine (Free and Total), plasma or serum WSLH Department: Biochemical Genetics (Phone: FAX: ) 531 Recommended Uses: Contraindications: Kit/Container: Quantification of free, total, and esterified carnitine Tandem Mass Spectrometry Monday through Friday 1 week Carnitine is a protein essential to fat metabolism (it is required to carry long chain fatty acids across the mitochondrial membrane; fatty acid oxidation occurs in the mitochondria to produce energy). Carnitine is stored mostly in muscle, only about 2% is found in blood, but blood is the source specimen of choice for testing because it is less invasive than obtaining muscle tissue. Carnitine deficiency can lead to muscle weakness (including the heart) and even sudden death. Treatment with oral carnitine is quite effective in treating cardiomyopathy and muscle weakness in children with carnitine deficiency. None Minimum 1mL plasma or serum Serum Separator Tube (red top) or Heparin Tube (green top) Patient Preparation: Preferred green top tube with either Sodium Heparin or Lithium Heparin additive or serum separator tube. Draw 2.5 times the volume requested. Immediately mix the blood by general inversion five to ten times. Separate plasma by centrifugation. Separate serum by allowing blood to clot followed by centrifugation. Transfer the plasma or serum to plastic screw top freezer vial. Freeze the specimen as soon as it is separated from red blood cells. Do not ship frozen plasma or serum in glass tubes. Handling and Transport: Plasma or serum should remain frozen during transport. NOTE: Refrigerated specimens are acceptable provided the time between collection and receipt is less than 24 hours. s sent at ambient temperature s with contamination (blood, bacteria, lipids) Mislabeled specimens Insufficient specimen quantity Requisition Form: Required Information: Biochemical Genetics Requisition Form Patient Name (unique identifier) Date of Birth Patient Age at collection (day/time of collection) Ordering physician Reason for referral Quantification of free, total, and esterified carnitine and interpretation of clinical significance 12

13 See result report for recommendations Additional Comments: Performed: 13

14 Methylmalonic Acid, plasma or serum WSLH Department: Biochemical Genetics (Phone: FAX: ) Recommended Uses: Contraindications: Kit/Container: BG00575 Quantification of methylmalonic acid and interpretation of clinical significance Liquid Chromatography-Tandem Mass Spectrometry Monday through Friday 2-4 days Quantification of methylmalonic acid can be used to assess patients for cobalamine (vitamin B12) deficiency or as a confirmation test and/or monitoring of patients with methylmalonic acidemia. None Minimum 1 ml plasma or serum Serum Separator Tube (red top) or Heparin Tube (green top) Patient Preparation: Preferred green top tube with either Sodium Heparin or Lithium Heparin additive or serum separator tube. Draw 2.5 times the volume requested. Immediately mix the blood by general inversion five to ten times. Separate plasma by centrifugation. Separate serum by allowing blood to clot followed by centrifugation. Transfer the plasma or serum to plastic screw top freezer vial. Freeze the specimen as soon as it is separated from red blood cells. Do not ship frozen plasma or serum in glass tubes. Handling and Transport: Plasma or serum should remain frozen during transport. NOTE: Refrigerated specimens are acceptable provided the time between collection and receipt is less than 24 hours. s sent at ambient temperature s with contamination (blood, bacteria, lipids) Mislabeled specimens Insufficient specimen quantity Requisition Form: Biochemical Genetics Requisition Form Required Information: Patient Name (unique identifier) Date of Birth Patient Age at collection (day/time of collection) Ordering physician Reason for referral Quantification for methylmalonic acid and an interpretation of clinical significance See result report for recommendations Additional Comments: 14

15 Methylmalonic acid/homocysteine Panel, plasma or serum WSLH Department: Biochemical Genetics (Phone: FAX: ) Recommended Uses: Contraindications: Kit/Container: BG00576 Quantification of methylmalonic acid and total homocysteine. Interpretation of clinical significance provided. Liquid Chromatography-Tandem Mass Spectrometry Monday through Friday 2-4 days Quantification of methylmalonic acid/total homocysteine can be used to assess patients for cobalamin (vitamin B12) deficiency and for monitoring of confirmed patients with methylmalonic acidemia. Total homocysteine quantification can also aid in screening for primary or secondary disorders of methionine metabolism and may also have implications for cardiovascular risk. None Minimum 1 ml plasma or serum Serum Separator Tube (red top) or Heparin Tube (green top) Patient Preparation: Preferred green top tube with either Sodium Heparin or Lithium Heparin additive or serum separator tube. Draw 2.5 times the volume requested. Immediately mix the blood by general inversion five to ten times. Separate plasma by centrifugation. Separate serum by allowing blood to clot followed by centrifugation. Transfer the plasma or serum to plastic screw top freezer vial. Freeze the specimen as soon as it is separated from red blood cells. Do not ship frozen plasma or serum in glass tubes. Handling and Transport: Plasma or serum should remain frozen during transport. NOTE: Refrigerated specimens are acceptable provided the time between collection and receipt is less than 24 hours. s sent at ambient temperature s with contamination (blood, bacteria, lipids) Mislabeled specimens Insufficient specimen quantity Requisition Form: Biochemical Genetics Requisition Form Required Information: Patient Name (unique identifier) Date of Birth Patient Age at collection (day/time of collection) Ordering physician Reason for referral Quantification for methylmalonic acid and total homocysteine and an interpretation See result report for recommendations 15

16 Organic Acids (Comprehensive Quantitative), urine WSLH Department: Biochemical Genetics (Phone: FAX: ) 554 Recommended Uses: Contraindications: Quantification of 10+ organic acids and interpretation GC Mass Spectrometer Monday through Friday 10 working days Will identify nearly all known organic acidemias. Organic acids are a broad class of compounds used in fundamental metabolic processes of the body (i.e. to generate cellular energy from dietary protein, fat and carbohydrate and provide the building blocks necessary for cell function). Accumulation of specific organic acids in urine often signals a metabolic inhibition or block. Examples of disorders identified by this test include methylmalonic acidemia, propionic acidemia, isovaleric acidemia, glutaric acidemia types I and II, Canavan disease and many others. Patients with certain fatty acid oxidation disorders and amino acid disorders also have organic acid abnormalities in urine. None Minimum 5mL urine Kit/Container: Patient Preparation: First morning void is ideal The normal composition of urine varies during a 24-hour period. Most reference values are based on analysis of first morning voided urine. This specimen is preferred (but not necessary) because it has a more uniform volume and concentration. Avoid dilute urines if possible. To reduce contamination the specimen submitted for analysis should be a clean catch mid stream sample. Handling and Transport: Urine should remain frozen during transport Note: refrigerated specimens are acceptable provided the time between collection and receipt is less than 24 hours. Ambient: unacceptable; Refrigerated: unacceptable; Frozen greater than 1 month: unacceptable s with contamination (blood, bacteria, lipids) Mislabeled specimens Insufficient specimen quantity Requisition Form: Biochemical Genetics Requisition Form Required Information: Patient Name (unique identifier) Date of Birth Patient Age at collection (day/time of collection) 16

17 Ordering physician Reason for referral Quantification of 10+ organic acids and an interpretation of clinical significance See result report for recommendations Additional Comments: Performed: 17

18 Total Homocysteine, plasma or serum WSLH Department: Biochemical Genetics (Phone: FAX: ) Recommended Uses: Contraindications: Kit/Container: BG00595 Quantification of total homocysteine. Interpretation of clinical significance provided. Liquid Chromatography-Tandem Mass Spectrometry Monday through Friday 2-4 days Total homocysteine quantification can be used to assess patients for cobalamin (vitamin B12) deficiency, and primary or secondary disorders of methionine metabolism. There is also a weak association between homocysteine concentrations and coronary heart disease. None Minimum 1 ml plasma or serum Serum Separator Tube (red top) or Heparin Tube (green top) Patient Preparation: Preferred green top tube with either Sodium Heparin or Lithium Heparin additive or serum separator tube. Draw 2.5 times the volume requested. Immediately mix the blood by general inversion five to ten times. Separate plasma by centrifugation. Separate serum by allowing blood to clot followed by centrifugation. Transfer the plasma or serum to plastic screw top freezer vial. Freeze the specimen as soon as it is separated from red blood cells. Do not ship frozen plasma or serum in glass tubes. Handling and Transport: Plasma or serum should remain frozen during transport. NOTE: Refrigerated specimens are acceptable provided the time between collection and receipt is less than 24 hours. s sent at ambient temperature s with contamination (blood, bacteria, lipids) Mislabeled specimens Insufficient specimen quantity Requisition Form: Biochemical Genetics Requisition Form Required Information: Patient Name (unique identifier) Date of Birth Patient Age at collection (day/time of collection) Ordering physician Reason for referral Quantification of total homocysteine and an interpretation of results. See result report for recommendations Additional Comments: 18

19 Chemical Response Lead, Blood, Capillary WSLH Department: Recommended Uses: Chemical Response (Phone: FAX: ) TX00468 Evaluation of potential lead poisoning Whole blood is diluted with a matrix modifier solution of ammonium phosphate/triton X- 100/nitric acid and analyzed by graphite furnace atomic absorption spectrometry. Monday-Friday 2 working days Blood lead testing for the identification of childhood lead poisoning. Contraindications: Kit/Container: Requisition Form: Required Information: Capillary specimens may be collected on children. A sample volume of 100 mcl is requested. Caution must be taken throughout the collection process to prevent environmental contamination of the specimens. Label with patient name and date of birth. Lead in Blood Toxicology Refer to Clin TOX GENOP 26, Blood Lead Capillary Procedure. Toxicology-Trace Metals Laboratory regulations require the following minimum information to be provided on the requisition form for a specimen to be accepted for testing: Patient name or unique identifier; date of collection, patient date of birth and sex, specimen type/site of collection, test request(s), reason for referral, clinician name and NPI, and address for reporting results. Please be certain that name/identifier on the form matches that on the specimen label. Acceptable range: Children 0-4 mcg/100 ml A venous specimen is the preferred specimen type due to the smaller risk of environmental contamination. Elevated blood lead results on capillary specimens should be confirmed using a venous specimen. Additional Comments: See Centers for Disease Control (CDC) guidelines for the interpretation of lead and EP blood levels. For information regarding appropriate medical and environmental follow-up for children with elevated blood lead levels, contact the WI Division of Public Health Childhood Lead Poisoning Prevention Program at For information regarding adult lead exposure, the Adult Blood Lead Epidemiology and Surveillance Program (ABLES), the Occupational Safety and Health Agency onsite occupational health/industrial hygiene consultation for small and medium sized businesses, and lead training and certification, contact the WI Department of Health & Family Services - Occupational Health at

20 Lead, Blood, Venous WSLH Department: Recommended Uses: Chemical Response (Phone: FAX: ) TX00467 Evaluation of potential lead poisoning Whole blood is diluted with a matrix modifier solution of ammonium phosphate/triton X- 100/nitric acid and analyzed by graphite furnace atomic absorption spectrometry. Monday-Friday 2 working days Blood lead testing for the identification of childhood lead poisoning and occupational lead exposure. Contraindications: 2 ml whole blood (Pediatric minimum is 0.1ml) collected in EDTA tubes following standard venous blood collection procedures. Heparin is also an acceptable anticoagulant. A venous specimen is required for diagnostic and medical management purposes. Label with patient name and date of birth. Kit/Container: Patient Preparation: Requisition Form: Required Information: Standard venipuncture procedure is appropriate. Toxicology-Trace Metals Laboratory regulations require the following minimum information to be provided on the requisition form for a specimen to be accepted for testing: Patient name or unique identifier; date of collection, patient date of birth and sex, specimen type/site of collection, test request(s), reason for referral, clinician name and NPI, and address for reporting results. Please be certain that name/identifier on the form matches that on the specimen label. Acceptable range: Children 0-4 mcg/100 ml, Adults 0-40 mcg/100 ml Additional Comments: See Centers for Disease Control (CDC) guidelines for the interpretation of lead and EP blood levels. For information regarding appropriate medical and environmental follow-up for children with elevated blood lead levels, contact the WI Division of Public Health Childhood Lead Poisoning Prevention Program at For information regarding adult lead exposure, the Adult Blood Lead Epidemiology and Surveillance Program (ABLES), the Occupational Safety and Health Agency onsite occupational health/industrial hygiene consultation for small and medium sized businesses, and lead training and certification, contact the WI Department of Health & Family Services - Occupational Health at Performed: 20

21 Mercury, Blood WSLH Department: Recommended Uses: Chemical Response (Phone: FAX: ) TX00472 Evaluation of potential mercury toxicity Blood mercury samples are diluted and the mercury is measured by inductively coupled plasma mass spectroscopy (ICP-MS). Monday-Friday 5 working days The blood mercury test evaluates potential mercury toxicity from exposure to inorganic, and organic forms of mercury. Contraindications: 2 ml of whole blood collected in evacuated tubes with EDTA (preferred) or heparin anticoagulant. Label with patient name and date of birth. Kit/Container: Patient Preparation: Standard venipuncture procedure is appropriate Handling and Transport: Requisition Form: Required Information: Toxicology-Trace Metals Laboratory regulations require the following minimum information to be provided on the requisition form for a specimen to be accepted for testing: Patient name or unique identifier; date of collection, patient date of birth and sex, specimen type/site of collection, test request(s), clinician name and NPI, and address for reporting results. Please be certain that name/identifier on the form matches that on the specimen label. Normal range: mcg/l A urine mercury test is preferred for detecting elemental (metallic) mercury exposure. Additional Comments: Performed: 21

22 Communicable Disease Arbovirus IgM Antibody Panel WSLH Department: CDD - Communicable Diseases Division (Phone: FAX: ) Recommended Uses: Contraindications: Kit/Container: Patient Preparation: SS02201 Qualitative IgM testing for Eastern Equine Encephalitis, St. Louis Encephalitis, La Crosse Encephalitis, West Nile Virus, Powassan Virus and Jamestown Canyon Virus. Qualitative IgM capture ELISA for JCV, POWV, EEE and LAC; Microsphere immunoassay (MIA) for WNV/SLE Once weekly One week Serodiagnosis of a recent infection with any of these agents in individuals with symptoms of arbovirus encephalitis with no other laboratory diagnosis. Testing will not be performed as a screening test or on patients without symptoms of arbovirus infection. 1-3 ml serum or 8.5 ml SST vacutainer tube, no additives; CSF, minimum 2 ml. CSF must be accompanied by serum specimen Serology s, Sterile Transfer Tube s should be collected in the acute phase of illness. Handling and Transport: s must be stored and transported to the lab at 2-8C (refrigerated/ with cool packs), and should be received within 48 hours of collection. Requisition Form: Required Information: Additional Comments: CDD Requisition Form B Clinical information regarding symptoms and onset must be provided. Laboratory regulations require the following minimum information to be provided on the requisition form for a specimen to be accepted for testing: Patient name or unique identifier; date and time of collection, patient date of birth and sex, specimen type/site of collection, test request(s), clinician name and UPIN, and address for reporting results. Please be certain that name/identifier on the form matches that on the specimen label. Negative, Presumptive Positive or Nonspecific for MIA assay. Numeric value and interpretation as Negative, Equivocal, Presumptive Positive or uninterpretable for CEIA assay. Cross-reaction may occur between the arboviruses. Negative results on a single acute phase specimen do not rule out infection, as specimen may have been obtained prior to the development of an antibody response. Enterovirus PCR Both MIA and CEIA test methodologies were developed at the CDC and validated at WSLH. They have not been cleared or approved by the U.S. Food and Drug Administration. 22

23 Bacillus anthracis Culture WSLH Department: CDD - Communicable Diseases Division (Phone: FAX: ) Recommended Uses: Contraindications: MP00330 Culture and identification of B. anthracis from lesions, eschars, tissue, blood, sputa, CSF, and other clinical specimens. Bacterial culture Daily, Monday - Saturday 2-5 Days To identify infection caused by Bacillus anthracis. Patient does not have clinical evidence of anthrax. Swab of lesion or eschar in sterile saline or bacterial transport medium; tissue; positive blood culture bottle; sputum. Kit/Container: Patient Preparation: Handling and Transport: Requisition Form: Required Information: Transport to laboratory as soon as possible. Notify WSLH before shipping. Refrigerated temperature Formalinized tissue and specimens in viral transport media are unacceptable for B. anthracis culture. CDD Requisition Form A Clinical information regarding symptoms and onset must be provided. Laboratory regulations require the following minimum information to be provided on the requisition form for a specimen to be accepted for testing: Patient name or unique identifier; date and time of collection, patient date of birth and sex, specimen type/site of collection, test request(s), clinician name and UPIN, and address for reporting results. Please be certain that name/identifier on the form matches that on the specimen label. Negative for B. anthracis; Culture shows Bacillus anthracis Organisms other than B. anthracis will not be identified. Additional Comments: If B. anthracis is suspected, please phone the WSLH prior to submission of clinical specimens. B. anthracis is a Select Agent under Federal regulations and must be reported to the CDC Select Agent Program. 23

24 Bacterial Identification, Non-Enteric Public Health Panel WSLH Department: CDD - Communicable Diseases Division (Phone: FAX: ) Recommended Uses: Contraindications: MP00470 Identification of bacteria of public health significance. Enteric bacteria not included. (See Enteric Pathogens, Referred Culture, test #MP00460.) Conventional biochemical testing; rdna sequencing when applicable, PCR Daily, Monday - Friday 2 days-2 weeks Identification of bacteria of public health significance (see Limitations). Bacteria not included in the Public Health Panel (see Limitations) are not identified and should not be submitted without prior authorization; contact the laboratory. Pure culture on agar slant. Plate media not recommended for shipping. Kit/Container: Patient Preparation: Handling and Transport: Requisition Form: Required Information: Ambient temperature using appropriate infectious substance shipping container. Do not submit mixed or non-viable cultures; do NOT freeze. CDD Requisition Form A Clinical information regarding symptoms and onset must be provided. Laboratory regulations require the following minimum information to be provided on the requisition form for a specimen to be accepted for testing: Patient name or unique identifier; date and time of collection, patient date of birth and sex, specimen type/site of collection, test request(s), clinician name and UPIN, and address for reporting results. Please be certain that name/identifier on the form matches that on the specimen label. Identification to genus and species when possible Bacterial Identification, Non-Enteric Public Health Panel is limited to bacteria of public health significance. These include bacteria that cannot be ruled out as a select agent (agent of bioterrorism), bacteria exhibiting multi-drug or otherwise unusual resistance, bacteria linked to an outbreak or cluster of illnesses, invasive bacteria from a sterile body site or bacteria under surveillance by WSLH and/ or the Wisconsin Division of Public Health. Please call or to inquire about whether an isolate is acceptable for submission. Additional Comments: 24

25 Bacterial Typing, Pulsed Field Gel Electrophoresis (PFGE) WSLH Department: CDD - Communicable Diseases Division (Phone: FAX: ) Recommended Uses: Contraindications: MP00628 Bacterial strain typing using chromosomal DNA restriction enzyme digestion patterns. Pulsed Field Gel Electrophoresis (PFGE) Daily, Monday - Friday 3 7 days To determine if isolates from different sources (i.e. patients and/or environmental sources) are genetically the same. This test is very discriminatory, and is primarily used in nosocomial or foodborne outbreaks. Isolates suspected of being related should be submitted together in batches whenever possible. Not recommended for routine testing purposes without supporting epidemiological information. Pure bacterial cultures on slants. Plates not recommended for shipping. Kit/Container: Patient Preparation: Handling and Transport: Requisition Form: Required Information: Additional Comments: Pick single colonies of each strain to an agar slant and incubate prior to shipment. Room temperature in suitable infectious substance shipping container. Single bacterial strains with no current or previous strains with which to compare are unacceptable. PFGE should only be performed on strains that are suspected of being epidemiologically related. CDD Requisition Form A Clinical information regarding symptoms and onset must be provided. Laboratory regulations require the following minimum information to be provided on the requisition form for a specimen to be accepted for testing: Patient name or unique identifier; date and time of collection, patient date of birth and sex, specimen type/site of collection, test request(s), clinician name and UPIN, and address for reporting results. Please be certain that name/identifier on the form matches that on the specimen label. Results are expressed in band patterns and associated dendrograms detailing the strains genetic relatedness. Accurate identification of bacterial strains must be made prior to PFGE testing; PFGE testing is not a method for identification of bacterial strains. Bacterial Identification, Non-enteric Public Health Panel (Test MP00470) if the identification of the strains submitted are not known. WSLH is currently performing PFGE analysis on Campylobacter species, Enterococcus sp., pathogenic Escherichia coli, Haemophilus influenzae, Legionella sp., Listeria monocytogenes, Neisseria meningitidis, Pseudomonas sp. (and Pseudomonas-like organisms), Salmonella sp., Shigella sp., and Staphylococcus aureus. Please call the laboratory at (608) if you wish to have PFGE testing performed on strains not listed above. 25

26 Bordetella Culture WSLH Department: CDD - Communicable Diseases Division (Phone: FAX: ) Recommended Uses: Contraindications: Kit/Container: MP00623 Culture for all Bordetella species of clinical significance Bacterial culture Daily, Monday - Saturday 4-10 days Detection of upper respiratory tract infections due to Bordetella species. Diagnosis of lower respiratory infections; patients who have completed antimicrobial therapy within one week of specimen collection Nasopharyngeal swabs or aspirates in media appropriate for the culture of Bordetella species Pertussis (a.k.a Whooping Cough, Bordetella) Patient Preparation: Handling and Transport: Requisition Form: Required Information: Additional Comments: Transport to the laboratory as soon as possible with a cool pack. Any delay will decrease our ability to culture the organism because of die-off of the Bordetella during transport. Dry swabs and swabs in viral transport are unacceptable for Bordetella culture. Avoid temperature extremes. CDD Requisition Form A Clinical information regarding symptoms and onset must be provided. Laboratory regulations require the following minimum information to be provided on the requisition form for a specimen to be accepted for testing: Patient name or unique identifier; date and time of collection, patient date of birth and sex, specimen type/site of collection, test request(s), clinician name and UPIN, and address for reporting results. Please be certain that name/identifier on the form matches that on the specimen label. Negative for Bordetella species; Culture shows Bordetella (species) Only Bordetella species of clinical significance will be identified. A negative result does not rule out infection with Bordetella species. Overgrowth by normal patient flora may inhibit growth of Bordetella species. Bordetella pertussis/parapertussis PCR (Test Code MP00311) Bordetella holmseii will not be recovered with the culture methods employed. Bordetella PCR is the optimal test for the detection of Bordetella pertussis/parapertussis infection. 26

27 Bordetella pertussis/ parapertussis PCR (also detects B. holmesii) WSLH Department: CDD - Communicable Diseases Division (Phone: FAX: ) Recommended Uses: MP00311 PCR assay for the detection of Bordetella pertussis and Bordetella parapertussis DNA in respiratory specimens. This assay also detects Bordetella holmesii. PCR 3 times weekly - Monday, Wednesday, Friday 1-3 days Test of choice for the diagnosis of Bordetella pertussis (whooping cough) and Bordetella parapertussis. Contraindications: Kit/Container: Dry nasopharyngeal swabs, or nasopharyngeal aspirates. Pertussis (a.k.a Whooping Cough, Bordetella) Patient Preparation: Handling and Transport: Requisition Form: Required Information: Kit 30; Dacron Swab or NP aspirate submitted in sterile, dry tube. s should be transported to the laboratory with cool pack. s should NOT be submitted in charcoal-based media or on wooden shaft swabs. Do NOT use cotton swabs. CDD Requisition Form A Clinical information regarding symptoms and onset must be provided. Laboratory regulations require the following minimum information to be provided on the requisition form for a specimen to be accepted for testing: Patient name or unique identifier; date and time of collection, patient date of birth and sex, specimen type/site of collection, test request(s), clinician name and UPIN, and address for reporting results. Please be certain that name/identifier on the form matches that on the specimen label. B. pertussis, B. parapertussis or B. holmesii DNA detected/ not detected This test is not FDA cleared or approved. Test results must be correlated with patient history and clinical presentation to confirm as a case of B. pertussis or B. parapertussis infection. A negative result does not rule out infection with B. pertussis or B. parapertussis. B. holmesii is an uncommon cause of respiratory illness in humans. Please include an additional swab in appropriate transport medium for Bordetella culture to use for public health/epidemiologic purposes. Cultures will be performed on PCR positive specimens to obtain an isolate for characterization. There will be no charge for this testing and culture results will not be reported to the submitter. See test code MP00623 for collection information. Additional Comments: 27

28 Botulism Culture WSLH Department: CDD - Communicable Diseases Division (Phone: FAX: ) MP02993 Referral of authorized specimens to the Minnesota Department of Health or the Centers for Disease Control and Prevention Contact the laboratory Recommended Uses: Test is performed only on patients who exhibit neurologic symptoms suggestive of botulism, in cases of infant botulism, on patients that have consumed food proven to contain botulinal toxin and only with prior approval of Wisconsin Division of Public Health. Contraindications: Contact the laboratory for specific instructions Kit/Container: Patient Preparation: Handling and Transport: Requisition Form: Required Information: Additional Comments: If botulism is strongly suspected and antitoxin treatment may be necessary, contact the WI Division of Public Health or your local health department immediately. 28

29 Botulism Toxin, Food or Stool WSLH Department: CDD - Communicable Diseases Division (Phone: FAX: ) MP02913 Referral of authorized specimens to the Minnesota Department of Health Contact the laboratory Recommended Uses: Test is performed only on patients who exhibit neurologic symptoms suggestive of botulism, in cases of infant botulism, on patients that have consumed food proven to contain botulinal toxin and only with prior approval of Wisconsin Division of Public Health. Contraindications: Contact the laboratory for specific instructions Kit/Container: Patient Preparation: Handling and Transport: Requisition Form: Required Information: Additional Comments: If botulism is strongly suspected and antitoxin treatment may be necessary, contact the WI Division of Public Health or your local health department immediately. 29

30 Brucella Antibody WSLH Department: CDD - Communicable Diseases Division (Phone: FAX: ) Recommended Uses: SS02002 Quantitative direct agglutination procedure for the detection of antibody to B. abortus, B. melitensis, and B. suis. Microagglutination Test is performed weekly 2-8 days To diagnose infection caused by B. abortus, B. melitensis, and B. suis in individuals with possible exposure. Brucellosis in humans has an insidious or abrupt onset, and no pathognomonic symptoms or signs; for these reasons, a serological test may be preferred over isolation of the organism. Contraindications: Kit/Container: Patient Preparation: Handling and Transport: Requisition Form: Required Information: Additional Comments: minimum 0.5 ml serum Serology s, Sterile Transfer Tube Routine blood draw Routine blood draw. Store serum specimen at 2-8 degrees C and transport with cool pack. CDD Requisition Form B Laboratory regulations require the following minimum information to be provided on the requisition form for a specimen to be accepted for testing: Patient name or unique identifier; date and time of collection, patient date of birth and sex, specimen type/site of collection, test request(s), clinician name and UPIN, and address for reporting results. Please be certain that name/identifier on the form matches that on the specimen label. Titer and interpretation. A single serum titer of >1:160 is suggestive of brucellosis when accompanied by a compatible clinical illness in a patient with potential exposure. A titer of up to 1:80 can be seen in a normal population. Testing of acute and convalescent specimens is recommended for the laboratory diagnosis of brucellosis, with the convalescent specimen collected at least 2 weeks after the acute. In the absence of bacteriologic confirmation, high or a four-fold or greater change in antibody titer is considered a presumptive diagnosis. The assay does not detect antibodies to B. canis or other rough types, such as the vaccine strain B. abortus RB51. Serology results should be interpreted in combination with other clinical, laboratory, and epidemiologic findings. Cross-reactions may occur with Francisella tularensis, Vibrio cholerae, Yersinia enterocolitica serotype O:9, Escherichia coli O:15, Afipia clevelandensis, and other antigenically related species. Francisella tularensis serology (SS02023) and Brucella culture (MP00350) Brucellosis is often related to occupational exposure. Serological results must be critically assessed along with clinical findings and occupational factors before a diagnosis is made. 30

31 Brucella Culture WSLH Department: CDD - Communicable Diseases Division (Phone: FAX: ) Recommended Uses: Contraindications: MP00350 Blood, bone marrow, abscess or tissue for isolation and identification of Brucella species. Bacterial culture Daily, Monday - Saturday 3 days 4 weeks To detect infections caused by Brucella species. Patients with no travel history or contact to animal sources (including unpasteurized dairy) have a low likelihood of Brucella infection. Blood and/or bone marrow in commercial aerobic blood culture bottle with CO2; Sterile vial for fluid specimens other than blood and bone marrow; Sterile vial with nonbacteriostatic saline for tissues Kit/Container: Patient Preparation: Handling and Transport: Requisition Form: Required Information: Additional Comments: Aerobic blood culture as per users protocol. Refrigerator temperature for specimens other than blood culture bottles. Ship blood culture bottles at ambient temperatures. It is recommended that specimens are received in the laboratory within hours of collection. Formalinized tissue is unacceptable for culture. CDD Requisition Form A Laboratory regulations require the following minimum information to be provided on the requisition form for a specimen to be accepted for testing: Patient name or unique identifier; date and time of collection, patient date of birth and sex, specimen type/site of collection, test request(s), clinician name and UPIN, and address for reporting results. Please be certain that name/identifier on the form matches that on the specimen label. Negative for Brucella species or Culture shows Brucella (with species identification) Blood cultures are only useful early in the acute phase of the disease. See Brucella Antibody (test #SS02002) It is best that blood cultures be incubated at the clinical laboratory. If positive for an isolate that cannot be ruled out as Brucella, submit the isolate to WSLH and order test code MP Extreme caution should be taken when handling isolates or specimens suspected of containing Brucella species. Brucella is a Select Agent under Federal Regulations and must be reported to the CDC Select Agent Program. 31