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Common diagnostic tests used in Hepatitis
Alanine aminotransferase (ALT, SGPT, GPT), serum

Normal Range: Laboratory-specific U/L
SI Units: 5kat/L
Blood tube color: Marbled
Cost: $9

Physiologic Basis:
* Intracellular enzyme involved in amino acid and carbohydrate metabolism. Present in large concentrations in liver, kidney; smaller amounts in skeletal muscle and heart. Released with tissue damage.

Increased in:
Acute viral hepatitis (ALT>AST), biliary tract obstruction (cholangitis, choledocholithiasis), alcoholic hepatitis and cirrhosis (AST>ALT), liver abscess, metastatic or primary liver cancer; right heart failure, ischemia or hypoxia, injury to liver ("shock liver"), extensive trauma. Drugs causing cholestasis and other hepatotoxic drugs.

* ALT screening of donor blood used in blood banks to exclude non-A, non-B hepatitis.

Aspartate aminotransferase (AST, SGOT, GOT), serum

Normal Range: Laboratory-specific U/L
SI Units: 5kat/L
Blood tube color: Marbled
Cost: $9

Physiologic Basis:
* Intracellular enzyme involved in amino acid and carbohydrate metabolism. Present in large concentrations in liver, skeletal muscle, brain, red cells, and heart. Released into the bloodstream when tissue is damaged.

Increased in: Acute viral hepatitis (ALT>AST), biliary tract obstruction (cholangitis, choledocholithiasis), mononucleosis, alcoholic hepatitis and cirrhosis (AST>ALT), liver abscess, metastatic or primary liver cancer, myocardial infarction, myopathies, muscular dystrophy, dermatomyositis, rhabdomyolysis, ischemic injury to liver ("shock liver") or hypoxia. Hepatotoxic drugs (eg, isoniazid).

Decreased in:

* Test not indicated for diagnosis of myocardial infarction.

Gamma-glutamyl transpeptidase (GGT), serum

Normal Range: Laboratory-specific U/L
SI Units: 5kat/L
Blood tube color: Marbled
Cost: $9

Physiologic Basis:
* GGT is an enzyme present in liver, kidney, and pancreas. * It transfers C-terminal glutamic acid from a peptide to other peptides of L-amino acids.
* It is induced by alcohol intake and is an extremely sensitive indicator of liver disease, particularly alcoholic liver disease.

Increased in: Liver disease: acute viral or toxic hepatitis, chronic or subacute hepatitis, cirrhosis, biliary tract obstruction (intrahepatic or extrahepatic), primary or metastatic liver neoplasm, alcoholic hepatitis, mononucleosis. Drugs (by enzyme induction): phenytoin, barbiturates, alcohol.

* Useful in follow up of alcoholics undergoing treatment. Test sensitive to modest alcohol intake.
* Test positive in 90% of patients with liver disease.
* Used to confirm hepatic origin of elevated serum alkaline phosphatase.

Bilirubin (T Bili), serum

Normal Range: 0.1-1.2 Direct (conjugated to glucuronide) bilirubin, 0.1-0.4 mg/dL (< 7 5mol/L); Indirect (unconjugated) bilirubin, 0.2-0.7 mg/dL (< 12 5mol/L) mg/dL
SI Range: 2-21 5mol/L
Blood tube color: Marbled
Cost: $22

Physiologic Basis:
* Bilirubin, a product of hemoglobin metabolism, is conjugated in the liver to the mono- and diglucuronides and excreted in bile. Some conjugated bilirubin is bound to serum albumin, so-called D (delta) bilirubin.
* Elevated serum bilirubin occurs in liver disease, biliary obstruction, or hemolysis.

Increased in: Acute or chronic hepatitis, cirrhosis, biliary tract obstruction, toxic hepatitis, congenital liver enzyme abnormalities (Dubin-Johnson, Rotor's, Gilbert's, Crigler-Najjar syndromes), fasting, hemolytic disorders. Hepatotoxic drugs.

* Assay of total bilirubin includes conjugated (direct) and unconjugated (indirect) bilirubin plus delta bilirubin (conjugated bilirubin bound to albumin).
* It is usually clinically unnecessary to fractionate total bilirubin. The fractionation is unreliable by the diazo reaction and may underestimate unconjugated bilirubin. Only conjugated bilirubin appears in the urine and it is indicative of liver disease; hemolysis is associated with increased unconjugated bilirubin.
* Persistence of delta bilirubin in serum in resolving liver disease means that total bilirubin does not effectively indicate time course of resolution.

Iron (Fe3+), serum

Normal Range: 50-175 5g/dL
SI Range: 9-31 5mol/L
Blood tube color: Marbled
Specfics of collection: Avoid hemolysis.
Cost: $9

Physiologic Basis:
* Plasma iron concentration is determined by absorption from intestine; storage in intestine, liver, spleen, bone marrow; rate of breakdown or loss of hemoglobin; rate of synthesis of new hemoglobin.
Increased in: Hemochromatosis, hemosiderosis (eg, multiple transfusions, excess iron administration), hemolytic anemia, pernicious anemia, aplastic or hypoplastic anemia, viral hepatitis, lead poisoning, thalassemia. Drugs: dextran, estrogens, ethanol, oral contraceptives.
Decreased in: Iron deficiency, nephrotic syndrome, chronic renal failure, many infections, active hematopoiesis, remission of pernicious anemia, hypothyroidism, malignancy (carcinoma), postoperative state, kwashiorkor, drugs.
* Used in evaluation of iron deficiency (see TIBC and Ferritin).

Iron binding capacity, total (TIBC), serum

Normal Range: 250-460 5g/dL
SI Range: 45-82 5mol/L
Blood tube color: Marbled
Cost: $34

Physiologic Basis:
* Iron is transported in plasma complexed to the metal-binding globulin, transferrin, which is synthesized in the liver.
* Total iron binding capacity is calculated from transferrin levels measured immunologically. Each molecule of transferrin has two iron-binding sites, so its iron binding capacity is 1.47 mg/g.
* Normally, transferrin carries an amount of iron representing about 16P60% of its capacity to bind iron, ie, % saturation of iron binding capacity is 16P60%.

Increased in: Iron deficiency anemia, late pregnancy, infancy, hepatitis. Drugs: oral contraceptives.

Decreased in: Hypoproteinemic states (eg, nephrotic syndrome, starvation, malnutrition, cancer), chronic inflammatory disorders, chronic disease, chronic liver disease.

* Increased % transferrin saturation with iron: in iron overload (iron poisoning, hemolytic anemia, sideroblastic anemia, thalassemia, hemochromatosis, pyridoxine deficiency, aplastic anemias).
* Decreased % transferrin saturation with iron: in iron deficiency (usually saturation <16%).
* Transferrin levels can also be used to assess nutritional status.

Cholesterol, serum

Normal Range: Desirable < 200 Borderline 200-239 High risk > 240 mg/dL
SI Range: Desirable < 5.2 Borderline 5.2-6.1 High risk > 6.2 mmol/L
Blood tube color: Marbled
Specfics of collection: Fasting preferred.
Cost: $9

Physiologic Basis:
* Cholesterol level is determined by lipid metabolism, which is in turn influenced by heredity, diet, and liver, kidney, thyroid, and other endocrine organ functions.
* Total cholesterol (TC) = LDLC + HDLC + TG/5 (valid only if triglyceride [TG] < 400).
* Since LDL cholesterol (LDLC) is the clinically important entity, it is calculated as LDLC = TC - HDLC - TG/5, and this is valid only if specimen is obtained fasting (in order to obtain relevant triglyceride and HDL levels).

Increased in: Familial or polygenic hyperlipoproteinemia, familial dysbetalipoproteinemia, familial combined hyperlipidemia, hyperlipoproteinemia and hyperalphalipoproteinemia, hyperlipoproteinemias secondary to hypothyroidism, uncontrolled diabetes mellitus, nephrotic syndrome, chronic hepatitis, biliary cirrhosis, obstructive jaundice, hypoproteinemia, glomerulonephritis, chronic renal failure, gout, malignancy (pancreas, prostate), pregnancy, alcoholism, glycogen storage diseases types I, III, IV, anorexia nervosa, GH deficiency, dietary excess. Drugs: androgens, chlorpropamide, corticosteroids, oral contraceptives, phenytoin, progestins, thiazides, others.

Decreased in: Acute hepatitis, alcoholic cirrhosis, Gaucher's disease, hyperthyroidism, acute infections, anemia, malnutrition, alphalipoprotein deficiency (Tangier disease), malignancy (liver), severe acute illness, extensive burns, COPD, rheumatoid arthritis, mental retardation, intestinal lymphangiectasia, apolipoprotein deficiency.

* It is important to treat the cause of secondary hypercholesterolemia (hypothyroidism, etc).
* National Cholesterol Education Program Expert Panel has published clinical recommendations for cholesterol management (see Ref 1).

Triglyceride (Tg), serum

Normal Range: < 165 mg/dL
SI Range: < 1.65 g/L
Blood tube color: Marbled
Specfics of collection: Fasting specimen required.
Cost: $9

Physiologic Basis:
* Dietary fat is hydrolyzed in the small intestine, absorbed and resynthesized by mucosal cells, and secreted into lacteals as chylomicrons.
* Triglycerides in the chylomicrons are cleared from the blood by tissue lipoprotein lipase
. * Endogenous triglyceride production occurs in the liver, and triglycerides are transported in association with b-lipoproteins (very low density lipoproteins).

Increased in: Hypothyroidism, diabetes mellitus, nephrotic syndrome, chronic alcoholism (fatty liver), biliary tract obstruction, stress, familial lipoprotein lipase deficiency; familial dysbetalipoproteinemia, familial combined hyperlipidemia; obesity, viral hepatitis, cirrhosis, pancreatitis, chronic renal failure, gout, pregnancy, glycogen storage diseases types I, III, VI, anorexia nervosa, dietary excess. Drugs: beta-blockers, cholestyramine, corticosteroids, diazepam, diuretics, estrogens, oral contraceptives.

Decreased in: Tangier disease (alpha-lipoprotein deficiency), hypo-and abetalipoproteinemia, malnutrition, malabsorption, parenchymal liver disease, hyperthyroidism, intestinal lymphangiectasia. Drugs: ascorbic acid, clofibrate, nicotinic acid, gemfibrozil.

* If serum is clear, triglyceride is < 350 mg/dL.
* Hypertriglyceridemia in an asymptomatic person who does not have a strong family history of coronary heart disease or a personal history of hypercholesterolemia is not a definite risk factor for coronary heart disease.

Lactate dehydrogenase (LDH), serum

Normal Range: Laboratory-specific
Blood tube color: Marbled
Specfics of collection: Hemolyzed specimens are unacceptable.
Cost: $9

Physiologic Basis:
* LDH is an enzyme that catalyzes the interconversion of lactate and pyruvate in the presence of NAD/NADH.
* It is widely distributed in body cells and fluids and since its RBC/plasma ratio is high, it is spuriously elevated in plasma/serum following hemolysis.

Increased in: Tissue necrosis, especially in acute injury of cardiac muscle, RBCs, kidney, skeletal muscle, liver, lung, skin. Commonly elevated in various carcinomas and in Pneumocystis carinii and B cell lymphoma in AIDS. Marked elevations occur in hemolytic anemias, vitamin B12 deficiency anemia, folate deficiency anemia, polycythemia vera, acute (but not chronic) hepatitis, cirrhosis, obstructive jaundice, renal disease, musculoskeletal disease, CHF. Drugs causing hepatotoxicity or hemolysis.

Decreased in: Clofibrate, fluoride (low dose).

* LDH is elevated after myocardial infarction (2P7 days), in liver congestion (eg, in CHF) and in Pneumocystis carinii pneumonitis.
* LDH is not a useful liver function test and it is not specific enough for the diagnosis of hemolytic or megaloblastic anemias.
* Its main diagnostic use is in myocardial infarction in which the CKMB elevation has passed. With the availability of specific LD1 measurements, the total LD level may no longer be useful.

Fetoprotein, a- (AFP), serum

Normal Range: 0-15 ng/mL
SI Range: 0-15 5g/L
Blood tube color: Marbled
Specfics of collection: Unhemolyzed
Cost: $48

Physiologic Basis:
* Alpha-fetoprotein is a glycoprotein produced both early in fetal life and by some tumors.

Increased in: Hepatocellular carcinoma (72%), massive hepatic necrosis (74%), viral hepatitis (34%), chronic active hepatitis (29%), cirrhosis (11%), regional enteritis (5%), benign gynecologic diseases (22%), testicular carcinoma (embryonal) (70%), teratocarcinoma (64%), teratoma (37%), ovarian carcinoma (57%), endometrial Ca (50%), cervical Ca (53%), pancreatic Ca (23%), gastric Ca (18%), colon Ca (5%).

Negative in: Seminoma


* In hepatocellular Ca or germ cell tumor associated with elevated AFP, the test may be helpful in detecting recurrence after therapy.
* The test is not sensitive or specific enough to be used as a general screening test. Screening may be justified in very high risk populations for hepatocellular Ca.
* AFP is also used to screen pregnant women for possible fetal neural tube defects. (There is a significant increase in maternal serum [or amniotic fluid] when compared with that expected at a given gestational age [15-20 weeks].)

Immunoglobulins (Ig), serum

Normal Range: IgA: 78-367 mg/dL IgG: 583-1761 mg/dL IgM: 52-335 mg/dL
Blood tube color: Marbled
Cost: $59

Physiologic Basis:
* IgG makes up about 85% of total serum immunoglobulins and predominates late in immune responses. It is the only immunoglobulin to cross the placenta.
* IgM antibody predominates early in immune responses.
* Secretory IgA plays an important role in host defense mechanisms by blocking transport of microbes across mucosal surfaces.

Increased in: IgG: Polyclonal: Autoimmune diseases (eg, SLE, RA), sarcoidosis, chronic liver diseases, some parasitic diseases, chronic or recurrent infections. Monoclonal: Multiple myeloma (IgG type), lymphomas or other malignancies. IgM: Polyclonal: Isolated infections such as viral hepatitis, infectious mononucleosis, early response to bacterial or parasitic infection. Monoclonal: Waldenstrom's macroglobulinemia, lymphoma. IgA: Polyclonal: Chronic liver disease, chronic infections (especially of the GI and respiratory tracts). Monoclonal: Multiple myeloma (IgA).

Decreased in: IgG: Immunosuppressive therapy, genetic (severe combined immunodeficiency, Wiskott-Aldrich syndrome, common variable immunodeficiency). IgM: Immunosuppresive therapy. IgA: Inherited IgA deficiency (ataxia telangiectasia, combined immunodeficiency disorders).

* IgG deficiency is associated with recurrent and occasionally severe pyogenic infections.
* Most common form of multiple myeloma is the IgG type.

Smooth muscle antibodies, serum

Normal Range: Negative
Blood tube color: Marbled
Cost: $43

Physiologic Basis:
* Detects antibodies against smooth muscle proteins.

Positive in: Autoimmune chronic active hepatitis (40P70%, predominantly IgG), lower titers in primary biliary cirrhosis (50%, predominantly IgM), viral hepatitis, infectious mononucleosis, neoplasia, cryptogenic cirrhosis (28%), <2% of normals.

* High titers (>1:80) may be useful to distinguish autoimmune chronic active hepatitis from other forms of hepatitis.

Antinuclear antibody (ANA), serum

Normal Range: < 1:20
Blood tube color: Marbled
Specfics of collection:
Cost: $31

Physiologic Basis:
* Heterogeneous antibodies to nuclear antigens (DNA and RNA, histone and nonhistone proteins).
* Antinuclear antibody is measured in patient's serum by layering serum over human epithelial cells and detecting the antibody with fluorescein-conjugated polyvalent anti-human immunoglobulin.

Elevated in: 1/3-3/4 of patients over age 65 (usually in low titers), systemic lupus erythematosus (98%), drug-induced lupus (100%), Sj gren's (80%), rheumatoid arthritis (30-50%), scleroderma (60%), mixed connective tissue disease (100%), Felty's syndrome, mononucleosis, hepatic or biliary cirrhosis, hepatitis, leukemia, myasthenia gravis, dermatomyositis, polymyositis, chronic renal failure.

* A negative ANA test does not completely rule out SLE, but alternative diagnoses should be considered.
* Pattern of staining of ANA may give some clues to diagnoses, but since the pattern also changes with serum dilution, it is not routinely reported. Only the rim (peripheral) pattern is highly specific (for SLE).
* Not useful as a screening test. Should be used only when there is clinical evidence of a connective tissue disease.

Antimitochondrial antibody, serum

Normal Range: Negative
Blood tube color: Marbled
Cost: $43

Physiologic Basis:
* Qualitative measure of antibodies against hepatic mitochondria.
* Rabbit hepatocytes are incubated with serum and then (after washing) with a fluorescein-tagged antibody to human immunoglobulin. Hepatocytes are then viewed for presence of cytoplasmic staining.

Increased in: Primary biliary cirrhosis (87-98%), chronic active hepatitis (25-28%); lower titers in viral hepatitis, infectious mononucleosis, neoplasms, cryptogenic cirrhosis (25-30%). <1% of normals; rare in extrahepatic biliary obstruction.

* Primarily used to distinguish primary biliary cirrhosis (antibody present) from extrahepatic biliary obstruction (antibody absent).

Rheumatoid factor (RF), serum -------------------------------------------------------------------- Normal Range: Negative (<1:16) Blood tube color: Marbled Cost: $16 Physiologic Basis: * Heterogeneous autoantibodies usually of the IgM class that react against the Fc region of human IgG. Positive in: Rheumatoid arthritis (75P90%), Sj gren's (80P90%), scleroderma, dermatomyositis, SLE (30%), sarcoidosis, Waldenstr m's macroglobulinemia. Drugs: methyldopa, others. Low titer can be found in healthy older patients (20%). 1P4% of normals and in a variety of acute immune responses (eg, viral infections, infectious mononucleosis, and viral hepatitis), chronic infections (tuberculosis, leprosy, subacute bacterial endocarditis) and chronic active hepatitis. Comments: * It can be useful in differentiating rheumatoid arthritis from other chronic inflammatory arthritides. However, a positive RF test is only one of several criteria needed to make the diagnosis of rheumatoid arthritis. (cf, Antoantibodies Table, p __) --------------------------------------------------------------------- Complement C3, plasma or serum -------------------------------------------------------------------- Normal Range: 64-166 mg/dL SI Range: 640-1660 mg/L Blood tube color: Lavender Cost: $32 Physiologic Basis: * The classic and alternative complement pathways converge at the C3 step in the complement cascade. Low levels indicate activation by one or both pathways. * Most diseases with immune complexes will show decreased C3 levels. * Test as usually performed is an immunoassay (by radial immunodiffusion or nephelometry). Increased in: Many inflammatory conditions as an acute phase reactant, active phase of rheumatic diseases (rheumatoid arthritis, SLE, etc), acute viral hepatitis, myocardial infarction, cancer, diabetes, pregnancy, sarcoidosis, amyloidosis, thyroiditis. Decreased by: Decreased synthesis (protein malnutrition, congenital deficiency, severe liver disease), or increased catabolism (immune complex disease, membranoproliferative glomerulonephritis [75%], SLE, Sj gren's, rheumatoid arthritis, disseminated intravascular coagulation, paroxysmal nocturnal hemoglobinuria, autoimmune hemolytic anemia, gram-negative bacteremia) and increased loss (burns, gastroenteropathies). Comments: * Complement C3 levels may be useful in following the activity of immune complex diseases. * The best test to detect inherited deficiencies is CH50. Levels can confirm specific C3 defect. -------------------------------------------------------------------- CD4/CD8 ratio (CD4/CD8), whole blood -------------------------------------------------------------------- Normal Range: Ratio: 0.8-2.9 CD4: 359-1725 cells/5L (29-61%) CD8: 177-1106 cells/5L (18-42%) Blood tube color: Lavender Specfics of collection: Also request a CBC and differential if absolute count is required. Cost: $ Physiologic Basis: * Lymphocyte identification depends on specific cell surface antigens (clusters of differentiation, CD) which can be detected with monoclonal antibodies using flow cytometry. * CD4 cells are predominantly helper-inducer cells of the immunologic system. They react with peptide class II major histocompatibility complex antigens and augment B cell responses and T cell lymphokine secretion. * CD8 cells can be divided into suppressor cells, which decrease B cell responses, and cytotoxic T cells. Increased in: Rheumatoid arthritis, type I diabetes mellitus, SLE without renal disease, primary biliary cirrhosis, atopic dermatitis, Sezary syndrome, psoriasis, chronic autoimmune hepatitis. Decreased in: AIDS/HIV infection, SLE with renal disease, acute CMV infection, burns, graft-versus-host disease, sunburn, myelodysplasia syndromes, acute lymphocytic leukemia in remission, recovery from bone marrow transplantation, herpes infection, infectious mononucleosis, measles, ataxia-telangiectasia, vigorous exercise. Comments: * Progressive decline in the number and function of CD4 lymphocytes seems to be the most characteristic immunologic defect in AIDS. CD4 measurement is particularly useful (more useful than the CD4/CD8 ratio) in determining eligibility for therapy and in monitoring the progress of the disease. * Absolute CD4 count depends, analytically, on the reliability of the white blood cell differential count, as well as on the percentage of CD4 cells identified using the appropriate monoclonal antibody. -------------------------------------------------------------------- Angiotensin-converting enzyme (ACE), serum -------------------------------------------------------------------- Normal Range: Method-dependent U/L SI Units: 5kat/L Blood tube color: Marbled Cost: $40 Physiologic Basis: * ACE is a dipeptidyl carboxypeptidase that converts angiotensin I to the vasopressor, angiotensin II. * ACE is normally present in the kidneys and other peripheral tissues. In granulomatous disease, ACE levels increase, derived from epithelioid cells within granulomas. Increased in: Sarcoidosis (65%), hyperthyroidism, acute hepatitis, primary biliary cirrhosis, diabetes, multiple myeloma, osteoarthritis, amyloidosis, Gaucher's disease, pneumoconiosis, histoplasmosis, miliary tuberculosis, drugs (dexamethasone). Decreased in: Renal disease, obstructive pulmonary disease, hypothyrodism. Comments: * Test is not useful as a screening test for sarcoidosis (low sensitivity). * Specificity is compromised by positive tests in diseases more common than sarcoidosis. * Some advocate measurement of ACE to follow disease activity in sarcoidosis. From Detmer WM, McPhee SJ, Nicoll D, Chou T. Pocket Guide to Diagnostic Tests. Appleton & Lange, 1992.
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