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CLEJAN, Ph.D. Clinical PathologylGeneral Laboratory (General Principles of Laboratory Medicine) Chemistry Hematology Microbiology Blood Bank:?-?-=Foundations (General Principles) of Laboratory Medicine Block >=$"Role of lab tests PCorrect diagnosis Appropriate therapy Restoration of patient health to normal:Q&(MObjective 1: To understand the use of laboratory tests in clinical practice. NM$. 1. Purposes of laboratory tests A. They are used for mass screening (e.g., phenylketonuria in newborns), screening asymptomatic patients (e.g., mammography), and screening symptomatic patients (e.g., stress electrocardiogram in a patient with chest pain). B. They are used to confirm a diagnosis (e.g., coronary angiogram to confirm coronary artery disease in a patient with a positive stress electrocardiogram). C. They are used to monitor a patient s disease status (e.g., serum glucose in a person with uncontrolled diabetes). 8>L  6Reasons for Testing - What is wrong with the patient?76( Discovery Confirmation Exclusion 1. Diagnosis 2. Prognosis 3. Screening 4. Monitoring 5. Determination of base line data 6. Decisions6!k"k Diagnosis Diagnosis is most important; a test or procedure that helps detect, confirm, document or exclude a disease. Once a disease is suspected, further tests aimed to increase or decrease the diagnostic certainty of one diagnosis to the exclusion of others.(  Prognosis Prognosis can be predicted, for example, by noting the degree of test abnormality. The higher the transaminase level in hepatitis, and the higher the creatine kinase MB isomer level in acute myocardial infarction, the more serious the disease and usually the worse the prognosis.(d !Symptomatic Patients: (C 1. Non-specific complaints 2. Specific problem already identified DC"Non-specific Complaints ( 1. Battery of chemistry tests 2. CBC 3. Urinalysis Problem: Positive test false positive results Solution: Repeat abnormal test on a different sample # "Specific problem Defined set of differential diagnosis Screening tests to pare down differential diagnosis (high sensitivity for a disease) 1). test negative - disease excluded 2). test positive true positive false posiitive USE TEST(S) WITH HIGH SPECIFICITY$## ,$ Monitoring` Measure progression or regression of a disease Response to treatment Response to drugs (levels) `a% ,TESTS USED TO MONITOR PATIENT DISEASE STATUS -, DISEASE Diabetes mellitus: adequacy of control Respiratory failure Heparin anticoagulation Rh hemolytic disease of the newborn Pneumonia Response to therapy in iron deficiency P^a,F_ TEST Glycosylated hemoglobin Pulse oximeter, which is a noninvasive test that measures the oxygen saturation of hemoglobin Partial thromboplastin time Amniocentesis and measurement of bilirubin pigment Chest x-ray Reticulocyte count and hemoglobin concentrationP pb  W'  $ Laboratory Screening Criteria ( 1. There must be a high enough prevalence of the disease to justify the expense. 2. Significant morbidity and mortality must be associated with the disease if it is left untreated. 3. The disease must be detectable before symptoms surface in the patient. 4. An effective therapy must be available that is safe and inexpensive. 5. The test must be cost effective and easily performed in the laboratory. *&!Sequence of Tests Depends on many factors: 1. Situation critical - test with the highest yield is done, even though there may be some risks 2. If there is time - lower yield, less risky procedure done first.,'"Order of Testing31. From cheap to costly 2. From less to more risky 3. And from simple to more complex Within the constraints of time, risk, and cost, try to do the test or procedure with the most efficiency as soon as possible; That is, use the procedure with the highest sensitivity, specificity, and predictive values. X42-)Order of Testing - Not always practical!(* 9 One or more objectives may be sacrificed for speed, convenience, accuracy, parsimony, a waiting list for procedures, time needed to await the results, and the condition of the patient. Some times it may be best to get the costly test done first; it may solve the problem quickly and save money in the long run.(993.Learn the Menus!XProfiles Batteries Panels What are the costs? What are the risks? What are the benefits??Y+&What Is Normal?Average Mean Usual Positive Test Negative Normal - result falls within a pre-determined range of values, reference values or cut-off points *%Reference IntervalBased on Gaussian statistics (2 SD from the mean of the test) Performance of large numbers of measurements in healthy people Mean value is determined Calculate 2 SD above AND bellow the mean 2.5% below 2.5% above normal 5.0% falsely normal 95% normal persons have normal valuesV>Y>: ,' Normal RangeReference values: urea - 10-20 mg/dl 200 mg/dl? 40 mg/dl? 25 mg/dl? could be a false positive? * How much above normal must the test result be before an intensive chain of studies is set into motion to determine the cause of the alleged abnormality?D%:%;-(Normal Range (cont.)$ $ How abnormal must a test result be before you become concerned? Common sense tells you to ignore a slightly abnormal result if the implied diagnosis is clinically highly unlikely, but to regard it seriously if the implied diagnosis is clinically likely.`\J ڑ(ڑ.) Perfect Test1). Accurate 2). Precise 3). Discriminating 4). Pain free 5). Risk free 6). Inexpensive 7). Useful There is no excuse for ordering a test, and then ignoring or overlooking the result which are actions that are commonly done."d~/*False Positive Test (F.P.)$$3Increases as more tests are performed on a patient % chance of F.P. = 100 - (0.95n X 100) n - # tests performed on a patient e.g.,6 tests ordered on a normal person - a 27% chance of a result falling outside the normal range (100 - (0.956 X 100) 20 tests ordered bring a 64% chance of an abnormal result.|Z#f;Q#s; Variables affecting lab tests 0 1. Preanalytical a. collection of sample b. age c. sex d. habits e. underlying diseases 2. Analytical-turbidity, hypoalbuminemia, mostly QC practices 3. Postanalytical a. reporting b. interpretation  >e  Collection of Blood ," Plasma anticoagulant in the collection tube chelating agents(EDTA,citrate) or heparin(enhance antithrombin111) Centifugation - 3 layers a. plasma b. buffy coat(WBC,platelets) c. RBCs  H?"O    !Serum no anticoagulant ," (( blood clots centrifugation deficient in fibrinogen prothrombin factor V factor VIII plateletsN) (Normal variations in reference intervals )(,"q a. Newborns b. Children c. Adult men d. Adult women e. Pregnant women f. Geriatric population ZEBRA HUNTS He d 0+Preanalytical Variables   Preanalytical variables related to the collection of the sample (e.g., blood, urine) and patient factors that alter test results, such as age, sex, habits, and underlying disease  1. Compared with that of a child, the hemoglobin (Hb) and RBC count in a newborn is higher owing to the increased concentration of HbF (fetal Hb) and its effect on left-shifting the oxygen dissociation curve, which leads to tissue hypoxia and the release of erythropoietin.,Kb4OX 2. Compared with that of an adult alkaline phosphatase (located in osteoblasts) and serum phosphate (which drives calcium, into bone) concentrations are higher in children because of active bone growth.,*   3. Adult men have higher TESTOSTERONE, Hb, serum iron, and serum ferritin (the circulating fraction of iron that correlates with iron stores) levels than adult women do, since adult women lose iron during menses and pregnancy if they do not take an iron supplement.  ,' 4. Pregnant women have notable test variations. a. The plasma volume increases three times more than the RBC mass, so the Hb concentration is reduced (dilutional effect). b. The increase in plasma volume increases the glomerular filtration rate (GFR), which increases the creatinine clearance and the clearance of analytes such as creatinine, blood urea nitrogen, and uric acid, hence lowering their serum concentrations.,0x0xty 8 +   Q  c. The increase in estrogen results in an increased synthesis of binding proteins such as thyroid-binding globulin and transcortin, which in turn results in an increase in the total thyroxine and total cortisol concentration, respectively, without altering the free hormone levels. d. There is a mild glucose intolerance, secondary to the anti-insulin effect of human placental lactogen, and a lower renal threshold for glucose, which often results in glucosuria in the presence of normal serum glucose concentration.6#"bz 5   B 9  5. Elderly patients have significant variations in test results that may be misinterpreted as representing disease. a. They have a significant drop in the GFR, which renders them susceptible to drug toxicity if they are given drugs that are excreted by the kidneys.,tt   b. There is a reduction in the number of suppressor CD8 T cells, leading to an increased production of autoantibodies. c. An increase in adipose tissue in the elderly down-regulates the synthesis of insulin receptors thus leading to mild glucose intolerance.  j 6. A hemolyzed sample of blood results in a false elevation of serum lactate dehydrogenase, potassium, and iron, since they are present in RBCs.> ? 0 7. A fasting blood sample is necessary in order to obtain accurate serum glucose and serum triacylglycerol (TG) levels, since diet affects these two analytes.,[*  8. Because alcohol enhances the activity of the cytochrome P-450 system in the liver, which is involved in drug metabolism, the serum concentration of a prescribed drug is likely to be lower than expected if alcohol is consumed./  9. 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61 08/18/99 11:08:29 OK 129.81.153.91 :www.tmc.tulane.edu:dingbats:transp100x20.gif 61 08/18/99 11:08:29 OK 129.81.142.9 :www.tmc.tulane.edu:dingbats:white.gif 61 08/18/99 11:08:29 OK 129.81.153.91 :www.tmc.tulane.edu:dingbats:pixel.gif 61 08/18/99 11:08:29 OK 129.81.142.9 :www.tmc.tulane.edu:dingbats:pixel.gif 61 08/18/99 11:08:29 OK 129.81.153.91 :www.tmc.tulane.edu:dingbatsDocumentSummaryInformation8BCurrent User0 ՜.+,D՜.+,d    'Customc): -TimesTimes New RomanSymbolMicrosoft Office 988INTRODUCTION TO LABORATORY MEDICINE CLINICAL PATHOLOGYClinical Pathology>Foundations (General Principles) of Laboratory Medicine BlockRole of lab testsNObjective 1: To understand the use of laboratory tests in clinical practice. 7Reasons for Testing - What is wrong with the patient? Diagnosis PrognosisSymptomatic Patients:Non-specific ComplaintsNo Slide Title Monitoring-TESTS USED TO MONITOR PATIENT DISEASE STATUSLaboratory Screening CriteriaSequence of TestsOrder of Testing*Order of Testing - Not always practical!Learn the Menus!What Is Normal?Reference Interval Normal RangeNormal Range (cont.) 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