The Clinical Significance of Urine Test Results

Modern Urine Chemistry— The Clinical Significance of Urine Test Results

Answers for life. One Simple Test, a Wealth of Information

Urinalysis is a fast, simple, inexpensive, and reliable tool for ruling in, or ruling out, many diseases related to carbohydrate metabolism, urinary tract health, kidney and liver function, acid-base balance, and many other medical conditions.1,2

Clinically relevant information can be obtained when analyzing the combined results of certain test parameters available on the urinalysis test strips. As with all laboratory tests, definitive diagnostic or therapeutic decisions should not be based on any single result or method.

Urinalysis testing Diabetes

Persons at Risk Symptoms Important Tests

• Persons with: Type 1: Leukocyte – Detects leukocyte esterase found in – Family history of diabetes • Excessive urination white blood cells – Obesity • Excessive thirst – High blood pressure • Unexplained weight loss Nitrite – Detects nitrate-reducing Leukocyte – Coronary artery disease (usually gram-negative) bacteria – History of gestational diabetes Type 2: Nitrite – Chronic pancreatitis • Excessive urination Ketones – May detect early ketoacidosis – Hepatic disorders • Excessive thirst in confirmed diabetics Urobilinogen – Cystic fibrosis • Fatigue Protein • Leg or foot pain Glucose – May detect unsuspected diabetes • Chronic use of medications • Tingling or numbness in hands/feet pH such as: • Ketoacidosis A:C Ratio (Microalbuminuria)* – May detect early high-dose glucocorticoids, • Hyperglycemia kidney damage associated with diabetes (available on Blood chemotherapy agents • Dehydration CLINITEK® Microalbumin Reagent Strips for Urinalysis) (L-asparaginase), • Sudden vision changes SG antipsychotics, and mood • Extreme hunger These tests provide useful information regarding Ketone stabilizers (phenothiazines) • Dry skin diabetes when performing a routine examination and/or managing people with confirmed diabetes. • Slow-healing sores Bilirubin • High risk ethnicity: • Frequent infections Hispanic (Latin American), The nitrite and leukocyte tests help detect urinary Glucose American Indian, tract infections, which are relatively common African American, complications of diabetes. A:C Ratio Pacific Islander, available on and South Asian ancestry The ketone test helps assess the severity of diabetes CLINITEK and avoid progressive diabetic ketosis, which can Microalbumin eventually lead to coma and even death. Reagent Strips for Urinalysis *NOTE: The American Diabetes Association recommends the annual measurement of microalbuminuria in all people with type 2 diabetes, and in people with type 1 diabetes with at least 5 years disease duration to aid in the early detection of kidney disease. A flow chart provided by the American Diabetes Association can be used as a guide to microalbuminuria testing.

Multistix® 10SG Reagent Strips for Urinalysis

Diabetes Eating Disorders

Persons at Risk Symptoms Important Tests

Anorexia: Anorexia: Specific Gravity – A high value may indicate • Teenage girls • Excessive dieting excessive vomiting • Adult women • Excessive weight loss • Persons with: • Underweight (85% of normal weight Ketones – Detects the presence of ketones Leukocyte – Low self-esteem for age/height) in urine that may indicate starvation or vomiting – Perfectionistic tendencies • Intense fear of gaining weight, Nitrite – Authoritarian parents even if underweight These tests, when analyzed in combination, provide – Family history • Distorted body image useful information regarding proper hydration Urobilinogen of eating disorders • Menstrual cycle disruption that may be compromised for people diagnosed Protein • Stress from: (stopped altogether or missed with eating disorders, such as anorexia nervosa – Alcohol/drug abuse 3 in a row) and bulimia nervosa. pH – Stressful home situations • Overexercises – Stress related to sports/ • Induces vomiting Blood academic achievement • Inappropriate use – Professions that require of laxatives or diuretics SG thinness: modeling/ballet • Fainting or severe lightheadedness Ketone • Constipation Bulimia: • Depression/anxiety Bilirubin • Persons with: – Previous history of Bulimia: Glucose being overweight • Binge eating – Family history of eating disorders • Self-induced vomiting – Low self-esteem • Inappropriate use of laxatives – History of physical, sexual, or diuretics or relational trauma • Overachieving behavior • Working or aspiring professions • Dental cavities/gingivitis due to that require thinness: acting, excessive vomiting modeling, ballet, or gymnastics • Electrolyte imbalance/dehydration

Multistix 10SG Reagent Strips for Urinalysis

Eating Disorders Kidney Disorders

Persons at Risk Symptoms Important Tests

Kidney Disease: Kidney Disease: Leukocyte – Indicates urinary tract infections that • Persons with: • Increased frequency in urination, can lead to kidney disorders – Family history of kidney disease especially overnight Protein – Detects the presence of proteinuria which – Diabetes • Swelling in legs, ankles, feet, face, may be caused by kidney malfunction Leukocyte – High blood pressure and/or hands – Autoimmune diseases • Fatigue pH – Used to determine type of kidney stone Nitrite – Systemic infections • Skin rash/itching – History of urinary tract infections • Metallic taste mouth/ammonia breath Blood – Detects blood in urine which may indicate Urobilinogen – Urinary stones • Nausea/vomiting damage to the kidney Protein – Lower urinary tract obstruction • Shortness of breath Specific Gravity and/or Creatinine – Provides a relative – Drug toxicity • Feeling cold indication of urine concentration or dilution (Creatinine pH • High risk ethnicity: • Trouble concentrating available on Multistix PRO®* Reagent Strips for Urinalysis) Hispanic (Latin American), • Dizziness Blood African American, Asian, • Leg/flank pain Protein-to-Creatinine (P:C) Ratio and Albumin-to- Pacific Islanders, and Creatinine (A:C) Ratio – Corrects for varying urine SG American Indians Kidney Stones: concentration, which improves the accuracy of result Ketone • Elderly • Lower back pain radiating to side interpretation, without a timed or 24-hour urine collection (P:C ratio available on Multistix PRO Reagent or groin Bilirubin Kidney Stones: • Pain during urination Strips for Urinalysis, and A:C ratio available on • Persons with: (stinging/burning) CLINITEK Microalbumin Reagent Strips for Urinalysis) Glucose – Dehydration • Blood in the urine (hematuria) Ratio Tests: – Excess amounts of Vitamin C • Increased frequency in urination P:C Ratio Measure both protein and creatinine while simultaneously or Vitamin D • Nausea/vomiting available on correcting for varying urine concentration. – High protein or sodium diets • Tenderness in the abdomen Multistix PRO – Effective for the clinical evaluation of people at risk Reagent Strips – Sedentary lifestyles and kidney region of developing chronic kidney disease for Urinalysis • Medications: Acetazolamide • Urinary tract infection – Able to be tested in both first morning or random, and A:C Ratio (Diamox) or Indinavir (Crixvan) • Fever/chills untimed “spot” urine specimens available • Loss of appetite on CLINITEK A:C Ratio Tests: Microalbumin A:C ratio tests are appropriate for testing people with Reagent Strips confirmed diabetes. These tests are recognized by the for Urinalysis. American Diabetes Association for detecting very low level of albuminuria (microalbuminuria). Multistix 10SG P:C Ratio Tests: Reagent Strips P:C ratio tests are appropriate for testing the broader for Urinalysis population with associated kidney disease risk factors. These tests are recognized by the National Kidney Foundation for detecting higher levels of protein than A:C tests.

*Not available in all markets.

Kidney Disorders UTIs Liver Disease or Damage

Persons at Risk Symptoms Important Tests

• Hepatitis A Infected Persons: • Jaundice Urobilinogen – Serves as an aid in detecting and – Exposure to fecal matter • Fatigue differentiating liver disease, hemolytic disease and • Weakness biliary obstruction • Hepatitis B Infected Persons: • Weight loss Leukocyte – IV drug users • Poor appetite Specific Gravity – Provides a relative indication – Persons having unprotected • Nausea of whether other tests results are affected by urine Nitrite sex with infected person • Fever concentration or dilution • Low blood pressure Urobilinogen • Hepatitis C Infected Persons: • Enlarged liver Bilirubin – May indicate abnormalities affecting the Protein – Exposure to contaminated • Fluid in the abdomen (ascites) liver or biliary system needles for IV drug users • Feeling of confusion pH – Persons with tattoos or • Prolonged itching of the skin Bilirubin and Urobilinogen results, when considered body piercings • Bright red complexion together, provide more helpful information for Blood – Persons having unprotected • Red palms differential diagnosis than either finding alone.3 sex with multiple partners SG

Ketone • Persons with: – Excessive alcohol Bilirubin consumption habits – Obesity Glucose – Fatty liver – Long-term dialysis

Multistix 10SG Reagent Strips for Urinalysis

Liver Disease/Damage UTIs Pregnancy Related Disorders

Persons at Risk Symptoms Important Tests

Pre-eclampsia: Pre-eclampsia: Pre-eclampsia: • First time pregnancy • High blood pressure Protein – May indicate pre-eclampsia during pregnancy • Multiple gestations • Swelling (Edema) Urinary protein tests are performed to aid in the • Chronic hypertension • Protein in urine diagnosis of pre-eclampsia, a condition of hypertension Leukocyte • Chronic diabetes and proteinuria that occurs in pregnancy and affects • Kidney disease Gestational Diabetes: about 5–12% of all pregnancies.5 Nitrite • Family history of eclampsia • Increased thirst or pre-eclampsia • Increased urination Urobilinogen Gestational Diabetes: • Teenagers or women over 40 • Weight loss in spite of • High risk ethnicity: increased appetite Glucose – May indicate gestational diabetes Protein Hispanic, African American • Fatigue Urinary testing for glucosuria during pregnancy pH • Nausea/vomiting can detect gestational diabetes, which accounts 4 Gestational Diabetes: • Frequent infections including for 88% of all pregnancies with diabetes present. Blood • Pregnant women bladder, vaginal and skin • Diabetic or family history • Blurred vision SG or diabetes • Past history or gestational diabetes Ketone • High risk ethnicity: Hispanic Bilirubin (Latin American), African American, Native American, Southern Glucose or Eastern Asian, Pacific Islander or Indigenous Australian • Obesity • Greater than 25 years of age • Still-birth or large baby with past pregnancy • Polycystic ovarian disease

Multistix 10SG Reagent Strips for Urinalysis

Pregnancy Disorders Sexually Transmitted Diseases (STD)

Persons at Risk Symptoms Important Tests

Gonorrhea: Gonorrhea: Leukocyte – Detects leukocyte esterase found • 15 to 19 year-old women Women: in white blood cells • 20 to 24 year-old men • Bleeding associated with • High-density urban areas vaginal intercourse Elevated test results may indicate detection Leukocyte • Multiple sex partners • Painful or burning sensations of bacteria responsible for STDs. • Unprotected sexual intercourse during urination Nitrite • Men having unprotected sex • Yellow or bloody vaginal discharge with other men Urobilinogen Men: Protein Syphilis: • White, yellow or green pus • High-risk sexual activity from penis with pain pH • Men having unprotected sex • Burning sensation during urination with other men • Swollen testicles Blood • HIV infected persons • Rectal infection: discharge and itching • Previous history of Syphilis • Painful bowel movements SG • Fresh blood in feces Ketone • Small, painless sore (chancre) on the part of body where infection Bilirubin is transmitted • Enlarged lymph nodes in groin Glucose • Skin rash and mucous membrane lesions • Sore throat • Patchy hair loss • General symptoms such as fever, fatigue, loss of appetite, and aches and pains in bones • Weight loss

Multistix 10SG Reagent Strips for Urinalysis

STDs UTIs Urinary Disorders

Persons at Risk Symptoms Important Tests

Renal: Renal: Blood – May indicate damage to the kidney • Persons with: • Blood in urine (hematuria) or urinary tract – History of smoking • Abnormal urine color (dark, rusty, – Family history of renal cancer or brown) Although there are many benign reasons for the Leukocyte – Genetic condition: • Back pain/flank pain presence of blood in urine, finding unexpected Hippel-Lindau disease • Abdominal pain/swelling and unexplained blood in the urine requires Nitrite • Receiving dialysis • Unintentional weight loss follow-up to determine the cause and rule out • Enlargement of one testicle the presence of cancer. Urobilinogen Bladder: • Vision abnormalities Protein • Persons with: • Excessive hair growth in females – History of smoking • Constipation pH – Exposure to occupational carcinogens (dye workers, Bladder: Blood rubber workers, aluminum • Blood in urine (hematuria) workers, leather workers, truck • Urinary frequency SG drivers, pesticide applicators) • Painful urination Ketone – Chronic bladder infections • Urinary urgency • Women receiving radiation • Urinary incontinence Bilirubin therapy for cervical cancer • Bone pain or tenderness • Patients treated with • Abdominal pain Glucose chemotherapy agents: • Anemia Cyclophosphamide (Cytoxan) • Weight loss • Elderly • Lethargy (tiredness)

Multistix 10SG Reagent Strips for Urinalysis

Urinary Disorders Urinary Tract Infections (UTI)

Persons at Risk Symptoms Important Tests

Women: • Pain or burning during urination Leukocyte – Detects leukocyte esterase found • Pregnant Women • Urge for frequent urination in white blood cells • Women with history of UTIs • Lower abdominal pain or heaviness • Menopausal women not • Reddish or pinkish urine Nitrite – Detects nitrate-reducing, Leukocyte taking estrogen • Cloudy urine gram-negative bacteria • Sexually active women • Foul smelling urine Nitrite • Back pain just below rib cage pH – Typically high or alkaline if UTI is present Men: (flank pain) Urobilinogen • Men with Prostatitis • Fever/chills Blood – May indicate damage to the urinary tract Protein • Men with Benign Prostatic • Nausea/vomiting Hyperplasia (BPH) • Diarrhea in young children In combination, these tests were found to be a better pH • HIV infected individuals predictor of the presence or absence of UTI, than any one parameter alone.6 Blood Women and Men: • Catheterized patients Urinalysis test strips are an effective “rule-out” tool SG • Persons with kidney stones for patients with suspected UTI. A key advantage Ketone • Diabetic persons of combining the results of leukocyte and nitrite is that if both tests are negative, very few UTIs will Bilirubin be missed. Glucose

Multistix 10SG Reagent Strips for Urinalysis

UTIs References Additional Information 1. Free, A.H. and Free, H.M.: Urinalysis, Critical www.my.webmd.com Discipline of Clinical Science. CRC Crit. Rev. www.urologychannel.com Clinical Lab Science. 1972; 3(4): 481-531 www.lifeoptions.org 2. Kark, R.M. et. Al: A Primer of Urinalysis, www.kidney.org 2nd ed. New York: Harper and Row; 1963. www.cdc.gov/diabetes 3. Encyclopedia of Analytical Chemistry, www.diabetes.org Chichester, UK Vol. 2. 2000; 1714-1723. www.nichd.nih.gov R.A. Myers (Ed.) John Wiley and Sons LTD. www.familydoctor.org www.mayoclinic.com 4. Diabetes Care; V. 18; No. 7; 7/95; 1029. www.nlm.nih.gov 5. American Journal of Obstetrics and Gynecology; V. 187; No. 3, 9/02; 703. 6. Robertson, AW, Duff P. The nitrite and leukocyte esterase tests for the evaluation of asymptomatic bacteriuria in obstetrics. Obstet. Gynecol 1988; 71:878-881 Siemens Healthcare Diagnostics, a global leader in clinical diagnostics, provides healthcare professionals in hospital, reference, and physician office laboratories and point-of-care settings with the vital information required to accurately diagnose, treat, and monitor patients. Our innovative portfolio of performance-driven solutions and personalized customer care combine to streamline workflow, enhance operational efficiency, and support improved patient outcomes.

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