Interpath Laboratory, Inc. Test File Update

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Arron Palmer
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As an Interpath customer who receives electronic results or sends electronic orders you may need to be notified when we update our Service Manual.

1 As an Interpath customer who receives electronic results or sends electronic orders you may need to be notified when we update our Service Manual. Although we try to keep these changes to a minimum, laboratory medicine is an evolving industry requiring changes to our technology from time to time. Depending on the requirements of your EMR or Hospital Information System you may be required to make similar changes to your system in order to correctly process inbound electronic results and create outbound electronic orders. If you are uncertain that you are required to update your system we recommend that you contact your vendor for more information. As your laboratory service provider we are available to participate in the discussion with your vendor so that you clearly understand the impact of these changes. Included in this This cover letter with a summary of the changes Microsoft Word Document with the detail of these changes to our Service Manual Interpath Master Order/Result Compendium Additional information including our most recent Service Manual and additional contact information can be found at Effective Dates: October 2, October 9, October 16, October, 23, 2017.

2 NC CC CPT SRC RRC NT DT AOE Order Code Test Name Name Change Component Change CPT Change Specimen Requirements Change * Allergy Testing (All) 2606 Glucose, Fasting + 2 HR 2467 Influenza A/B Rapid 1090 Kappa Lambda Free Light Chain Kappa-Lambda Free Light Chains, Quantitative 2179 Testosterone 2126 Vitamin B12 Reference Range Change New Test Discontinued Test Ask on Order Entry Questions

3 Allergy Testing Please take note of the following reference range change applicable to all allergy testing. Effective: October 16, Allergen Reference Ranges: Class 0: <0.1 ku/l Absent or Undetected Class 0/1: ku/l Clinical Relevance Undetermined Class 1: ku/l Low Class 2: ku/l Moderate Class 3: ku/l High Class 4: ku/l Very High Class 5: ku/l Very High Class 6: >100 ku/l Very High Allergens scoring in Class 0/1 have uncertain clinical relevance but could be a risk factor for future sensitization. Allergens scoring in Class 2 or higher have an increasing probability of contributing to a total allergenic load and can be considered clinically relevant. Test performed by ImmunoCAP Specific IgE Blood Test technology. See next page for list of components affected.

4 Below is a list of all Allergy testing component names and test numbers MILK, COWS [IGE] EGG WHITE [IGE] SOYBEAN [IGE] WHEAT [IGE] FISH, COD [IGE] PEANUT [IGE] CORN [IGE] WALNUT [IGE] SCALLOP [IGE] SHRIMP [IGE] CASHEW [IgE] HONEY BEE [IGE] YELLOW HORNET [IGE] PAPER WASP [IGE] YELLOW JACKET [IGE] WF HORNET SESAME SEED [IGE] PEA [IGE] HAZEL NUT [IGE] BRAZIL NUT [IGE] ALMOND [IGE] PECAN NUT [IGE] CRAB [IGE] TOMATO [IGE] PORK [IGE] BEEF [IGE] CARROT [IGE] ORANGE [IGE] POTATO [IGE] COCONUT [IGE] TUNA [IGE] SALMON [IGE] STRAWBERRY [IGE] YEAST [IGE] ONION [IGE] APPLE [IGE] RYE [IGE] BARLEY [IGE] OAT [IGE] LOBSTER [IGE] CHICKEN MEAT [IGE] MELONS [IGE] RICE [IGE] CHOCOLATE [IGE] GARLIC [IGE] EGG YOLK [IGE] CASEIN [IGE] GLUTEN [IGE] CHEESE, CHEDDAR [IGE] CHEESE, MOLD [IGE] MUSTARD [IGE] BANANA [IGE] TEA [IGE] CINNAMON [IGE] BEAN, WHITE-NAVY [IGE] CLAM [IGE] GREEN BEAN [IGE] TURKEY MEAT [IGE] PEACH [IGE] COFFEE [IGE] MALT [IGE] MAPLE/BOX ELDER [IGE] GRAY ALDER [IGE] COMMON BIRCH [IGE] OAK [IGE] COTTONWOOD [IGE] WALNUT, TREE [IGE] SYCAMORE [IGE] WILLOW [IGE] PINE, WHITE [IGE] MOUNTAIN JUNIPER [IGE] ELM [IGE]

5 80111 ASH [IGE] LOCUST [IGE] RUSSIAN OLIVE [IGE] MULBERRY [IGE] BERMUDA GRASS [IGE] REDTOP GRASS [IGE] BROME GRASS [IGE] CULTIVATED RYE [IGE] VELVET GRASS [IGE] CULTIVATED WHEAT [IGE] CORN POLLEN [IGE] ORCHARD GRASS [IGE] MEADOW FESCUE [IGE] RYE-GRASS [IGE] TIMOTHY GRASS [IGE] KENTUCKY BLUE [IGE] MUGWORT [IGE] RUSSIAN THISTLE [IGE] PIGWEED, COMMON [IGE] LAMB''S QUARTER [IGE] COCKLEBUR [IGE] FIREBUSH, KOCHIA [IGE] SHEEP SORREL [IGE] RAGWEED, WESTERN [IGE] RAGWEED, FALSE [IGE] ENGLISH PLANTAIN [IGE] SUGAR-BEET [IGE] RAGWEED, COMMON [IGE] SCALE [IGE] ALFALFA [IGE] SAGEBRUSH [IGE] MARSHELDER [IGE] NETTLE [IGE] GOLDENROD [IGE] SUNFLOWER [IGE] CAT DANDER EPITH [IGE] DOG DANDER [IGE] HORSE DANDER [IGE] COW DANDER [IGE] FEATHERS, MIXED [IGE] ARA H 1 [IGE] ARA H 2 [IGE] ARA H 3 [IGE] ARA H 8 PR-10 [IGE] ARA H 9 LTP [IGE] ALPHA-LACTALBUMIN [IGE] BETA-LACTOGLOBULIN [IGE] OVOMUCOID [IGE] OVALBUMIN [IGE] DERMAT. FARINAE [IGE] DERMAT. PTERO [IGE] HOUSE DUST, HOLLISTER [IGE] COCKROACH [IGE] ALTERNARIA TENUIS [IGE] PENICILLIUM CHRYS [IGE] CLADOSPORIUM [IGE] ASPERGILLIUS [IGE] MUCOR RACEMOSUS [IGE] CANDIDA ALBICANS [IGE] SETOMELAN. ROSTR. [IGE] BOTRYTIS [IGE] STEMPHYLLIUM [IGE] RHIZUPUS NIGRICAN [IGE] PHOMA [IGE]

6 2606 Glucose, Fasting + 2 HR CC One Gray Top (2HR) One Gray Top (FAST) Special Handling: One SST (2HR) One SST (FAST) Two 4 ml (Min:1 ml) Whole blood in Gray Top. Submit Refrigerated. Two 1 ml (Min:0.5 ml) Plasma. Submit Refrigerated. Submit in a Standard Transport Tube. Two 1 ml (Min:0.5 ml) Serum in SST. Submit Refrigerated. Draw fasting specimen, then give 75gm glucola (or 2 hours post meal). At 2 hour draw "2 HR" post sample. Label tubes "Fasting" and "2 HR". Rejection Criteria: Stability: Methodology: Performed: Reported: Other alternative samples: Green Top (Li Hep), Lavender EDTA, Pink EDTA, Red Top. If using alternative serum or plasma separate from cells ASAP. Serum or plasma stability: Ambient 8 hrs, RF 3 days, FZ 1 month Hemolyzed specimens Microbially Contaminated Unlabled Specimens Ambient: 1 Day(s); Refrigerated: 3 Day(s); Frozen: Unacceptable; Incubated: Unacceptable Colorimetric; Kinetic Mon-Fri 1-3 Day(s) CPT Codes: Interpretive Data: Please see report for interpretive data. Components: GLUCOSE, FASTING GLUCOSE, POST Please take note of change in components from 1023 Glucose to 2400 Glucose, Fasting. Effective: October 16, 2017.

7 2467 Influenza A/B Rapid SRC Nasal Swab in Sterile Specimen Container Nasopharyngeal Swab in Sterile Specimen Container Nasal Swab in Sterile Specimen Container. Submit Refrigerated. Nasopharyngeal Swab in Sterile Specimen Container. Submit Refrigerated. Special Handling: Use only the flocked swab provided in the kit. If transport is required, place the swab in Viral Transport Media and refrigerate. To perform Influenza A/B via DFA a separate nasopharyngeal swab, aspirate or washing needs to be collected and placed in Viral Transport Media. Rejection Specimens collected from other sources. Swabs other than those provided in the ImmunoCard STAT! Flu A&B test kit. Criteria: Stability: Ambient: 4 Hour(s); Refrigerated: 8 Hour(s); Frozen: Unacceptable; Incubated: Unacceptable Methodology: Solid Phase Immunoassay Performed: Mon-Fri Reported: 1-2 Day(s) CPT Codes: Interpretive Please see report for interpretive data. Data: Components: INFLUENZA A INFLUENZA B Please take note of changes in collection, submission requirements, special handling, rejection criteria, stability, and methodology. Effective: October 2, 2017 In an effort to improve the accuracy of rapid influenza testing, the U.S. Food and Drug Administration (FDA) recently announced the reclassification of these assays to ensure higher sensitivities, higher specificities and detection of currently circulating and newly emerging strains. Interpath Laboratory will be changing to a new rapid influenza diagnostic kit to meet these requirements.

8 1090 Kappa Lambda Free Light Chain DT One SST One Red Top 1 ml (Min:0.5 ml) Serum. Submit Refrigerated. Submit in a Standard Transport Tube. Special Handling: Allow for complete clot formation Avoid Repeated Freeze/Thaw Cycles Seperate from cells as soon as possible. Rejection Criteria: Hemolyzed specimens Lipemic Samples Microbially Contaminated Plasma Stability: Ambient: 2 Hour(s); Refrigerated: 3 Week(s); Frozen: 24 Month(s); Incubated: Unacceptable Methodology: Immunoturbidometric Performed: Tuesday, Thursday Reported: 2-5 Day(s) CPT Codes: 83883x2 Interpretive Data: Please see report for interpretive data. Components: KAPPA LAMBDA K/L RATIO Discontinuing test and replacing with Kappa-Lambda Free Light Chains, Quantitative. Effective: October 23, 2017.

9 91460 Kappa-Lambda Free Light Chains, Quantitative NT Special Handling: Rejection Criteria: One SST One Red Top 2 ml (Min:0.5 ml) Serum. Submit Refrigerated. Submit in a Standard Transport Tube. Separate serum from cells ASAP or within 2 hours of collection Plasma Specimen submitted at room temperature Ambient: 2 Hour(s); Refrigerated: 1 Week(s); Frozen: 2 Week(s); Incubated: Unacceptable Quantitative Nephelometry Stability: Methodology: Performed: Mon-Fri Reported: 2-5 Day(s) CPT Codes: 83883x2 Interpretive Data: Please see report for interpretive data. Components: KAPPA QNT LAMBDA RATIO New testing to replace 1090 Kappa Lambda Free Light Chain. Please take note of differences in submission requirements, special handling, rejection criteria, stability, methodology and days performed changes. Effective: October 23, 2017.

10 2179 Testosterone Reporting Change One SST Special Handling: One Green Top (Li Heparin) One Lavender (EDTA) One Pink Top (EDTA) One Red Top 1 ml (Min:0.5 ml) Serum. Submit Refrigerated. Submit in a Standard Transport Tube. 1 ml (Min:0.5 ml) Plasma. Submit Refrigerated. Submit in a Standard Transport Tube. Allow specimen to clot completely at room temperature Avoid Repeated Freeze/Thaw Cycles Minimize air exposure Separate from cells ASAP Specimen should be collected between 6-10 a.m. Stability: Ambient: 8 Hour(s); Refrigerated: 1 Week(s); Frozen: 6 Month(s); Incubated: Unacceptable Methodology: Electrochemiluminescence Immunoassay (ECLIA) Performed: Mon-Fri Reported: 1-3 Day(s) CPT Codes: Interpretive Data: Male Reference Ranges 0-11 year(s) : ng/dl year(s) : ng/dl year(s) : ng/dl year(s) : ng/dl year(s) : ng/dl Female Reference Ranges 0-11 year(s) : ng/dl year(s) : ng/dl year(s) : ng/dl 20 year(s) - 49 : ng/dl year(s) : ng/dl Results less than 12.0 ng/dl will be reported as <12.0 ng/dl due to limitations in testing methodology. Effective: October 9, To determine accurate levels of Testosterone below 12.0 ng/dl, order test (Testosterone LC/MS [Women, Children])

11 2126 Vitamin B12 SRC/RRC One SST One Green Top (Li Heparin) One Green Top (Na Heparin) One Lavender (EDTA) One Pink Top (EDTA) One Red Top 1 ml (Min:0.5 ml) Serum. Submit Refrigerated. 1 ml (Min:0.5 ml) Plasma. Submit Refrigerated. Special Handling: Fasting Specimen is Preferred Minimize air exposure Protect from Light Separate from cells within 2 hours of collection SST collection stable for 24 hours. Rejection Criteria: Grossly Hemolyzed Samples Heat inactivated Stability: Ambient: 2 Hour(s); Refrigerated: 2 Day(s); Frozen: 2 Month(s); Incubated: Unacceptable Methodology: Electrochemiluminescence Immunoassay (ECLIA) Performed: Mon-Fri Reported: 1-3 Day(s) CPT Codes: Interpretive Data: General Reference Range : pg/ml Please take note of changes in collection, special handling, rejection criteria, stability, and reference range. Effective: October 9, 2017.

Milan Analytica AG Baslerstrasse Rheinfelden

Milan Analytica AG Baslerstrasse 15 4310 Rheinfelden www.milananalytica.ch Product list valid from 01.09.2012 Please ask for evaluation samples under Product Article number Circulating immune complexes