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Clinitest hCGIn-Service TrainingMaria Peluso-Lapsley, CDM MarketingSept 2018, HOOD05162002951655 ver 1.01Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Table of ContentsClinitest hCG In-Service Training hCG testing Clinitest hCG test overview Getting the analyzer ready for testing Performing quality control testing Performing patient testing Interpreting test results Avoiding errors Performing routine maintenance/cleaning Ordering information Quiz2Unrestricted Siemens Healthcare Diagnostics Inc., 2018

hCG TestingClick to add footnotesecond line3UnrestrictedRestricted Siemens Healthcare Diagnostics Inc., 2018

What is hCG? Human Chorionic Gonadotropin (hCG) is ahormone released early in pregnancy hCG is detected in the urine as early as 14days after conception Rapid and reliable marker for early detectionof pregnancy4Unrestricted Siemens Healthcare Diagnostics Inc., 2018

hCG Levels and Pregnancy hCG helps track the early stages ofpregnancy Initially, the level of hCG rises very rapidly,approximately doubling in quantity every 2days until a peak is reached between thesixth and eighth week Over the next ten or more weeks, the levelof hCG decreases Detectable levels of hCG may be present amonth or two after delivery The first catch of urine in the morning willcontain the highest level of hCG5Unrestricted Siemens Healthcare Diagnostics Inc., 2018

hCG Presence Differences – Serum vs. UrineIn normal pregnancy, hCG can bedetected in serum as early as sevendays following conceptionUrine hCG concentrations areapproximately one half (or less thanone half) of serum concentrationshCG in urine can be detected asearly as 14 days from the date ofconceptionDetected as early asUrine hCG concentrationsDetected as early as7 Days 1/214 Days(in serum)of that in serum(in urine)6Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Clinitest hCGOverviewClick to add footnotesecond line7UnrestrictedRestricted Siemens Healthcare Diagnostics Inc., 2018

Clinitest hCG Test Overview Qualitative test for early detection ofpregnancy For use on CLINITEK Status family ofanalyzers Instrument-read test only, not approved forvisual testing Uses urine sample only Results reported as early as 2 minutes ifpositive and up to 5 minutes to confirm anegative result CLIA-waived when tested on the CLINITEKStatus family of analyzers8Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Why Clinitest hCG Pregnancy Test?Eliminates error sources Accurately times the test Automatically interpretsand transmits test resultsImproves workflowefficiency True walkawayconvenience—addsample and the analyzerdoes the rest Results in as little as2 to 5 minutes Bar-code scanningoptions —saves time,simplifies data entry, andeliminates transcriptionerrorsProvides fail-safe measures Unique borderline result—eliminates forcedinterpretation Operator lock out—prevents use byunauthorized usersImproves data capture andtraceability Connectivity—automaticallyrecords and transmits resultsto EMR or LIS 100% data capture forbilling purposes Audit-ready—results linkedto patient, operator ID,material lot number andexpiration date9Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Clinitest hCG Kit Content 25 individually, foil-wrapped hCG cassettesEach foil pack contains: 1 hCG test cassette 1 single-use pipette desiccant to prevent moisture Instructions for Use10Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Test Kit Storage and Stability Store test kit at either refrigerated or at roomtemperature, 2 to 30 C (36 to 86 F) for theduration of the shelf-life If refrigerated, bring the wrapped cassettes toroom temperature before opening theprotective pouch to avoid moisturecondensation Do not use the test cassettes beyond theexpiration date11Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Getting Readyfor TestingClick to add footnotesecond line12UnrestrictedRestricted Siemens Healthcare Diagnostics Inc., 2018

Supplies Needed to Conduct TestingAnalyzer and TestsRecommended Supplies:(supplied by Siemens or authorized distributor):CLINITEK Status Family of AnalyzersClinitest hCG test kit(non-Siemens Healthineers items):Urine specimen collection containersQuality control materials13Unrestricted Siemens Healthcare Diagnostics Inc., 2018

PerformingQualityControl TestingClick to add footnotesecond lineAuthor Department 14UnrestrictedRestricted Siemens Healthcare Diagnostics Inc., 2018

Quality Control Testing ModesCLINITEK Status Analyzer(stand-alone):CLINITEK Status ConnectSystem (with connectorbase):No QC mode.Control samples are treatedand stored as patientsamples. User must entercontrol name or ID todistinguish resultsControl results must bemanually compared to thevalues assigned by thecontrol manufacturerIf the control results arenot favorable, do not testpatient samples untilquality control is passedHas a separate QC mode anddatabase for QC resultsCLINITEK Status ConnectSystems can be set-up byuser to automatically checkQC results and initiate a QClock out when results failIf the control results are notfavorable, do not test patientsamples until quality controlis passed15Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Quality Control TestingAnalyzer Checks:QC Testing Tips: Analyzer automatically performs the followingquality checks with each test for: Use recommended quality control solutions sufficient sample proper sample flow proper technique Analyzer will generate errors when theseconditions are detected Use only the pipette provided with the hCGcassette to ensure only 200 µL of QC material isdispensed If using dropper bottles for QC materials, ensureonly 200 µL of QC material is added for testing Counting the number of drops of QC material maylead to incorrect sample volume and erroneous QCtest results Using more or less than the required 200 µL maycause an error16Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Quality Control Testing Recommendations For CLIA-waived laboratories, both a negativeand positive level should be tested whenopening a new lot of reagents, new shipmentof reagents, or when reagents stored formore than 30 days. Note: Water should not be used as anegative control For all other laboratories, run QC testing asper the quality control procedure defined byyour institution to ensure compliance to localand State regulatory requirements17Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Quality Control Materials Some urinalysis commercial controls tend to be very dark in color because of added analytes This dark color has been shown to cause background color on the Clinitest hCG test cassette, and can contribute to E67 andE68 errors See below the commercial controls that are compatible with Clinitest hCG tests: Quantimetrix Dipper Dipstick Control Quantimetrix Dipper POCT Liquid Urinalysis Control Quantimetrix Dropper Plus POC Urine Dipstick Control Set Bio-Rad qUAnitfy Plus Control, Bi-level Bio-Rad qUAntify Conrol, Bi-level MAS Urinlaysis Liquid Assayed Urinalysis Control Kenlor Liquid Urine Dipstick Control StanBio hCG Bi-Level Urine ControlReference: Clinitest hCG Customer BulletinCUST-00259-EDG, Rev D18Unrestricted Siemens Healthcare Diagnostics Inc., 2018

PerformingPatient TestingClick to add footnotesecond line19UnrestrictedRestricted Siemens Healthcare Diagnostics Inc., 2018

Specimen Collection and Handling Collect urine into a clean, dry container Specimens collected at any time of day maybe used Refrigerate specimens at 2 to 8 C (36 to46 F) for up to 72 hours, if the testing is notperformed immediately If samples are refrigerated, bring them toroom temperature (20 C to 30 C) beforetesting20Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Performing a Test21Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Performing a TestTo Avoid Errors:Do not add sample to the cassetteuntil prompted by the analyzer.To Avoid Errors:Do not add sample to sample welluntil after you press the “START” button.22Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Performing a TestTo Avoid Errors: Only use the pipette provided with each cassette. Ensure the pipette stem is completely filled. Do not overfill the sample; only one pipette stem is required. Ensure the entire pipette stem is dispensed. Do not attempt to dispense any sample that is in the overflow chamber. If you are using dropper bottles for QC materials, ensure that only 200 µL of control material is added.23Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Performing a Test24Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Performing a Test Lot number and expiration dating of the test cassettefoil can be entered in one single scan if: Barcode is connected and enabled Lot information is enabled in set-up25Unrestricted Siemens Healthcare Diagnostics Inc., 2018

InterpretingTest ResultsClick to add footnotesecond lineAuthor Department 26UnrestrictedRestricted Siemens Healthcare Diagnostics Inc., 2018

Result Interpretation Review – for illustration purposes only(This test is NOT approved for visual reading)Each test cassette has 3 important areas that the analyzers uses toperform integrity checks and interpret test resultsCControl LineAnalyzer checks for presence of thecontrol line to confirm cassetteintegrity.RReference LineLine intensity is anchored to reflect alevel for positive result comparison.TTest LineDevelopment of this line representsthe intensity line of a patient sampleor control based upon the amount ofhCG present in the urine.BorderlineNote: This test is for instrument interpretation onlyand is not approved for visual interpretation This test is approved for urine only, othersample types cannot be tested27Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Analyzer Interpretation of Results for Clinitest hCGPositive: If the hCG intensity ismore than 25mIU/mL and boththe control andreference regionsmeets the minimumintensity (Note: hCG levels of100 mIU/mL can bereached on the dayof the first missedmenstrual period.)Borderline:(repeat in 48-72 hours) If the hCG intensity isless than 25 mIU/ml,but more than 5mIU/ml and both thecontrol and referenceregions meets theminimum intensityNegative:Invalid: If the hCG intensity isless than 5 mIU/ml The instrument willautomaticallydetermine if aprocedural error or atest reagentdeterioration hasoccurred The user will beadvised to repeat thetest and contactsupport if theproblem persists28Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Analyzer Result Interpretation ReviewCLINITEK Status family of analyzers are opticallylooking for the development of lines to interpretresults: The analyzer compares the intensity of theTest line to the Reference line to determineif the sample is positive or negative If analyzer cannot determine if the intensityof the line is clearly negative or positive, itwill report a borderline result29Unrestricted Siemens Healthcare Diagnostics Inc., 2018

AvoidingErrorsClick to add footnotesecond lineAuthor Department 30UnrestrictedRestricted Siemens Healthcare Diagnostics Inc., 2018

Conditions which may produce borderline hCGresult (5-25 mIU/mL) Women of childbearing age who have experienced a spontaneous abortion: 22% of pregnancies abort spontaneously, undetected1 At the beginning of normal pregnancy, hCG concentrations rise rapidly, and hCG levels slowly return to normal( 5 mIU/mL) after spontaneous abortion1 hCG levels may remain detectable for several weeks following delivery, miscarriage or hCG injections(in vitro fertilization treatments) Low levels of hCG in these urine samples may cause false-positive results for any qualitative hCG pregnancy test Passively acquired hCG levels from a blood transfusion Trophoblastic diseases, including a variety of cancers If a borderline result is obtained repeat test in 48–72 hoursSource: Obstet Gynecol. 1984 Sept; 64 (3):391-431Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Conditions which may produce borderline hCG result(5-25 mIU/mL)NCCLS Guidelines for borderline results:“For general diagnosis of pregnancy, the result can be safely regarded as negative,and the test can be repeated at a later time, if warranted In cases wherepregnancy must be ruled out - for example, before performing an elective test ortreatment that is contraindicated in pregnancy - a borderline result can be taken asnot ruling out pregnancy.”1) Choriogonadotropin Testing: Nomenclature, Reference Preparations, AssayPerformance, and Clinical Application; Approved Guideline I/LA 10-A Vol. 16 No. 14 –December 199632Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Sample Integrity IssuesCheck for the following sample integrity issues prior to using the Clinitest hCG test: Visibly bloody or severely turbid urine samples could indicate a compromised sample. If a qualitativeinterpretation is inconsistent with the clinical evidence, results should be confirmed by an alternative hCGdetection method. Viscous (mucoid) samples may interfere with the sample flow. Highly colored samples may interfere with the test. If these conditions exist, do not use the test and re-test with a fresh sample, if possible. In acute situations, you may opt to have a blood sample drawn from the patient and confirm result by a quantitativelab test33Unrestricted Siemens Healthcare Diagnostics Inc., 2018

In Summary – To Avoid Common ErrorsImproper technique may cause errors. To minimize errors: Use only pipette provided with the test kit. It is metered to delivery 200 µL sample Do not overfill sample well; only one pipette stem is required. Overfilling leads to erroneous results Only empty sample in pipette stem. Do not attempt to empty sample from overflow reservoir Add sample to sample well only after pressing the START button Use recommended quality control solutions Properly store test cassettes Use CLINITEK Status family of analyzers to interpret results – this test is not cleared for visual use34Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Avoiding Common Error CodesCommon ErrorsPotential CausesProper operator actionsE67 Errors –Insufficient SampleHighly colored control materialsUse recommended control solutions.Highly colored or extremelybloody patient sample.Do not test. Collect new sample and run new test.Insufficient sample or empty cassette.Ensure that you are using the pipette provided in the kit to deliver theproper amount.If using external controls, ensure that 200 µL of control material is beingadded. Again, use the pipette provide in the kit to deliver the properamount.E68 ErrorsInsufficient SampleExcess sample, overfilling of sample wellwith more than one pipette-full.Ensure that you are using the pipette provided in the kit, which has beendesigned to deliver 200 µL. Only use one pipette-full.Viscous sample.Collect fresh sample and retest.35Unrestricted Siemens Healthcare Diagnostics Inc., 2018

What substances may interfere with hCG results?The following substances may interfere with test results: Preservatives Micro-organisms Erythrocytes and/or leucocytes36Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Should I use only urine as the sample type? Urine is the ONLY sample type that has beenvalidated for use with Clinitest hCG test onthe CLINITEK Status family of analyzers Other samples (such as whole blood, plasma,water, and non-urine based controls) maygive invalid results due to their ionic strength,pH, or matrix components37Unrestricted Siemens Healthcare Diagnostics Inc., 2018

What are False Positives? A false positive is when a positive resultis generated from a sample containing 25 mIU/ml hCG. All qualitative pregnancy tests will producea small number of false positive results( 1%). Always evaluate not only the diagnostic testresult, but also all other clinical signs andsymptoms.38Unrestricted Siemens Healthcare Diagnostics Inc., 2018

What are potential causes of false positive results? Borderline results are “indeterminate” and should notbe considered as a false positive results The presence of interfering substances: Endogenous proteins Spontaneous abortions may cause false results;hCG may remain in the bladder for hours before beingvoided Drugs Use of contaminated urine collection containers,if contaminated with detergent, for example Erythrocytes and/or Leukocytes Microorganisms Improper sample addition: overfilling with more than200 µL or under filling with less than 200 µL of sample Use of a cassette that is too warm or running the test ina warm environment A soiled instrument calibration bar39Unrestricted Siemens Healthcare Diagnostics Inc., 2018

What are potential causes of false negative results? Pre-embryo implantation Urine samples collected in containers contaminated with, for example, detergent Improper sample addition: under filling of the sample well Concentrated (high specific gravity) urines containing low levels of hCG (near the sensitivity level) Urine contaminated with protease (proteolytic enzymes) Using a cassette that is too cold, or running the test in a cold environment An instrument calibration bar that is soiled40Unrestricted Siemens Healthcare Diagnostics Inc., 2018

What if a positive hCG result is not in linewith other clinical signs? As is true with any diagnostic test, clinicaldiagnosis should not be based solely on asingle test result Clinical diagnosis should incorporate allclinical and laboratory data and look at “thebigger picture” Ensure the proper sample application stepsare being followed and that therecommended controls are being used41Unrestricted Siemens Healthcare Diagnostics Inc., 2018

What hCG results will we obtain on dark-colored urine(bilirubin or hemolyzed blood)? It is unlikely that non-hemolyzed blood cells will give invalid results. However, if these cells accumulate at the edge ofthe membrane, they may cause reduced flow, which could give invalid results It is unlikely that bilirubin will cause a problem as it has limited solubility and is photosensitive – No interference frombilirubin was noted in clinical trials It is likely that dark-colored urines would give an error message for high background or improper reference lineformation (E67 or E68 error) instead of an incorrect result Visibly bloody or severely turbid urine samples could indicate a compromised sample. If a qualitative interpretation isinconsistent with the clinical evidence, results should be confirmed by an alternative hCG detection method42Unrestricted Siemens Healthcare Diagnostics Inc., 2018

If in doubt If a positive test result is obtained and nonpregnancy is suspected, it is standardlaboratory and clinical practice to have thetest repeated with another urine sampleobtained 48 hours later (bear in mind thathCG levels in pregnant women approximatelydouble every 2 days) In acute situations, it is recommended thatthe result is confirmed with a quantitativelaboratory test43Unrestricted Siemens Healthcare Diagnostics Inc., 2018

PerformingRoutineMaintenance/CleaningClick to add footnotesecond lineAuthor Department 44UnrestrictedRestricted Siemens Healthcare Diagnostics Inc., 2018

CLINITEK Status Family - Analyzer Maintenance Clean the test table at least once a week toremove any build up. The test table can besoaked in 5% hypochlorite and rinsedthoroughly – do not use solvents.45Unrestricted Siemens Healthcare Diagnostics Inc., 2018

CLINITEK Status Family - Maintenance Check that the calibration strip on theinstrument is clean every day. If not, cleanwith a cotton swab or soft cloth and wateronly, ensuring that you do not scratch it.46Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Replacing the Printer Paper47Unrestricted Siemens Healthcare Diagnostics Inc., 2018

OrderingInformationClick to add footnotesecond lineAuthor Department 48UnrestrictedRestricted Siemens Healthcare Diagnostics Inc., 2018

Ordering Information49Unrestricted Siemens Healthcare Diagnostics Inc., 2018

QuizClick to add footnotesecond lineAuthor Department 50UnrestrictedRestricted Siemens Healthcare Diagnostics Inc., 2018

Quiz1. Name two of the essential points to remember when collecting a specimen.2. At what level does the Clinitest hCG test report a positive result?3. Name some scenarios where you may get a positive hCG in a non-pregnant woman.4. What would you do if you get a borderline test result?5. Name three proper techniques that minimize errors?6. What are the recommended cleaning procedures for the CLINITEK Status analyzer?51Unrestricted Siemens Healthcare Diagnostics Inc., 2018

Thank you!CLINITEK, CLINITEK Status, Clinitest, DCA Vantage and all associated marks are trademarksof Siemens Healthcare Diagnostics Inc., or its affiliates. All other trademarksand brands are the property of their respective owners.52Unrestricted Siemens Healthcare Diagnostics Inc., 2018

hCG Levels and Pregnancy hCG helps track the early stages of pregnancy Initially, the level of hCG rises very rapidly, approximately doubling in quantity every 2 days until a peak is reached between the sixth and eighth week Over the next ten or more weeks, the level of hCG decreases D

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