5/16/2011. Objectives of the Presentation. Questions for the Audience. 1. Do you currently prescribe narcotics at your practice? A. Yes B.

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1 Rapid Diagnostic Testing : Point of Care Perspectives Prepared for CONTINUING MEDICAL EDUCATION TEXAS OSTEOPATHIC MEDICAL ASSOCIATION TEXAS SOCIETY OF THE AMERCAN COLLEGE OF OSTEOPATHIC FAMILY PHYSICIANS CONFERENCE 1717 North Akard Street Dallas, TX, June 17 th, :00-11:00 a.m. Objectives of the Presentation Introduction to my Technical Department. Explanation of Rapid Diagnostic Testing (standard terminology). Review of useful Point-of-Care products for physicians. Highlight products that address gaps in patient care. 1. Do you currently prescribe narcotics at your practice? 1

2 2. Do you currently screen for drug use amongst those patients given narcotic prescriptions? 3. Is there a clinical utility in drug screening patients with chronic pain? A. True B. False 4.Do you currently screen for colorectal cancer? 2

3 5.Do you currently screen for colorectal cancer using a guaiac test? (For those who answered yes) 6. Do you currently use a urine strip during patient visits? 7. Do you routinely send patient samples for TSH, T3, T4 laboratory testing (at least 4 in the past month)? 3

4 8. Do you believe your practice is currently generating the most income it can through reimbursement on patient testing? Standard Rapid Test Terminology Analyte Sensitivity Specificity Accuracy Cut-Off Lateral Flow Background Intensity External Control Internal Control The thing being detected by the test. A measure of the ability of a test to detect a given concentration of analyte. A measure of the ability of a test to distinguish between similar compounds. A measure of positive agreement and negative agreement between the test and some other method determined to be a gold standard of the highest accuracy. A concentration of analyte at which a test is 50% sensitive. The movement of a liquid sample through material of a test to yield a result. The color of a rapid test which fades up to the read time. A term explaining the depth of color present in a line. One or more solutions used to determine the performance of a rapid test. A line present in the rapid test to determine if appropriate lateral flow was achieved. About the BTNX Inc. - Technical Department Operations Director Colin Eric Hall, Ph.D. Chemistry Sales Staff Support Value Assignment listings Proficiency Testing listings Medical Device Complaint Handling Research and Development of new tests for emerging trends 4

5 A Review of Point-of-Care Testing Products Drugs of Abuse Fecal Immunochemical Test (FIT) Helicobacter pylori Mononucleosis Ovulation, Pregnancy and Menopause Influenza AB (H1N1) Urinalysis Thyroid Stimulating Hormone Blood Glucose Monitoring System Strep A Respiratory Syncytial Virus Rotavirus and Adenovirus Drugs of Abuse Drug Abuse Epidemic In 2008, an estimated 24.1 million Americans aged 12 or older admitted to illicit drug use within the last month (> 8% of the population). Pain relievers Tranquilizers Stimulants Sedatives OSTEOPATHS SHOULD BE VIGILENT WHY? More than half of adults in the United States experienced chronic or recurrent pain in Substance abuse disorders are common in patients taking opioids for back pain and aberrant medication-taking behaviors occur in up to 24% of cases. 7 of the 10 Most Abused Drug Classes Belong to Prescription and Over-the-Counter medications National Institute on Drug Abuse 2011 Substance Abuse and Mental Health Services Assoc. Prescription Drug Abuse is on the rise, in every age cohort. Drugs of Abuse Point of Care Testing Formats Panel Cassette Integrated Cup Strip 5

6 Drugs of Abuse Sample: Urine or Saliva Sensitivity: Set to SAMHSA recommended cut-off Specificity: Determined using calibrators Test Time: 3-8 mins Expiration Dating: months Reimbursement: CPT G0434QW $20.83/test Colorectal Cancer A Closer Look Clinical Features: Screening for colorectal cancer is responsible for significant decrease in the disease. Screening can find precancerous polyps that can be removed before turning into cancer. If found early and treated, the 5-year survival rate is 90%. Due to low screening rates less than 40% of colorectal cancers are found early. ACS/CDC Recommend: Men and women regardless of ethnic groups (those aged 50 years or older) should be screened. Incidence: In ,672 people in the United States were diagnosed with colorectal cancer, including 72,755 men and 69,917 women. 53,219 people in the United States died from colorectal cancer, including 27,004 men and 26,215 women. It is the third most common cancer for men and women. Percentage of adults aged 50 years who reported receiving a FOB within the past year and/or a lower endoscopy. Immunological Fecal Occult Blood Test Fecal Occult Blood testing can lead to peptic ulcers or a malignancy. Guaiac-based Fecal Occult Blood tests pick up a daily blood loss of 10 ml (about two teaspoonfuls). Immunochemical Fecal Occult Blood tests pick up a daily blood loss of about 0.3 ml. The American College of Gastroenterologists (2008) supports the joint guideline recommendations that the older guaiac-based fecal occult blood test be abandoned as a method for CRC screening. The ACG recommends the FIT as the preferred cancer detection test. Cassette Sample: Feces Sensitivity: 98% ; 50 ng Human Hemoglobin/mL Specificity: 98% ; Human Hemoglobin Test Time: 5-10 mins Expiration Dating: months Reimbursement: CPT 82274QW $22.38/test Buffer Tube 6

7 5/16/2011 Fertility Point of Care The detection of the Luteinizing Hormone surge indicates impending ovulation. Positive readings suggest that ovulation is about to occur within hours. Pregnancy HCG testing relies on HCG secreted after embryo implantation. It is the oldest and most established form of pregnancy testing. Sample: Urine Sensitivity: 20 miu Human Chorionic Gonadotropin Specificity: >99% No cross reaction with FSH or LH Test Time: 40 sec. - 5 mins Expiration Dating: months Reimbursement: CPT 81025QW $8.90/test Sample: Urine Sensitivity: 20 miu Luteinizing Hormone Specificity: >99% No cross reaction with FSH Test Time: 40 sec mins Expiration Dating: months Reimbursement: CPT 84830QW $14.02/test In menopausal or post-menopausal women, urine is identified by a elevated Follicle Stimulating Hormone FSH concentration. Sample: Urine Sensitivity: >99% 25 miu FSH Specificity: >99% No cross reaction with HCG or LH Test Time: mins Expiration Dating: months Reimbursement: CPT 83001QW $25.97/test Urinalysis Clinical Utility: Urinalysis represents an array of tests performed on urine and is one of the most common methods of medical diagnosis. A part of a urinalysis can be performed visually on urine dipsticks, in which the test results are interpreted by color changes. Another method is to use an analyzer containing a CCD camera. Trends: Ever increasing accuracy values. Improvements in urine strip accuracy are obtained with better components and engineering (ie. ascorbic acid protection). In addition urine strips are designed to detect a specific condition such as pre-diabetic conditions (pathological ratios of 2 components such as a Microalbumin / Creatinine strip). 120 Urine Analyzer 10 parameters Test Cycle: 60 seconds, 120 tests/hour fast mode. Memory: 1,000 test results Dimensions: Length 5.9 x Width 8.3 x Height 4.4 inches. Screen Size: 3.25 x 1.5 inches. Urinalysis Reagent Strips 10-Parameter 2-Parameter MIC/CRE Sensitivity: Negative - Pathological Specificity: 1 to 10 parameters and Microalbumin/Creatinine Test Time: Visually sec. : Machine 60 sec. Expiration Dating: months (30 days once opened) Reimbursement: CPT 81002QW $3.57/test CPT 81002QW $6.67/test 4. 7

8 Urinalysis Ranges What you might expect to see in a normal individual and what is clinically pathological? Ranges for 10 Parameter Urine Strip Ranges for Microalbumin/Creatine Urine Strip Thyroid Stimulating Hormone Clinical Features: Primary hypothyroidism is characterized by elevated TSH levels, above 5.0 miu/l and low free T4 levels. Symptoms include poor muscle tone, fatigue, cold intolerance, constipation and weight gain. ATA Recommends: To establish the diagnosis of hypothyroidism a serum TSH measurement and a free T 4 estimate (or direct measurement) should be performed in a laboratory. The use of a rapid screen for elevated TSH can also be useful in screening individuals prior to laboratory determination. Incidence: Primary hypothyroidism is one of the most common under-diagnosed conditions, especially in women (over 13,000,000 Americans). Sensitivity: 5mIU/L Primary Hyperthyroidism Test Format: Finger-Stick or Venipuncture Test Volume: 50 µl Blood Drop Test Time: 5-10 min Expiration Dating: months Reimbursement: CPT 84443QW $23.64/test Blood Glucose Monitoring System Blood glucose monitoring is the standard approach for managing Diabetes. Blood Glucose Meter Lancing Device & Lancet Vials & Code chip Controls High & Low Sensitivity: <3.3 mmol/l (Hypoglycemia) >13.3 mmol/l Hyperglycemia Test Format: AST and Finger-Stick Test Volume: 0.7µL Blood Drop Test Time: 7 sec. Expiration Dating: months 8

9 Diabetes A Closer Look at U.S. Trends State of Texas - Rate of New Cases of Diagnosed Diabetes per 1000 Adults Total: 25.8 million children and adults (8.3% of the population) Diagnosed: 18.8 million people Undiagnosed: 7.0 million people Pre-diabetes: 79 million people New Cases: 1.9 million diagnosed in Cost: $174 billion: Total costs of diagnosed diabetes in the United States in Rate of New Cases of Diabetes by State Per 1000 Adults Courtesy of the American Diabetes Association and the CDC Helicobacter pylori Test Kit Approximately 10-20% of those colonized by H. pylori will ultimately develop gastric and duodenal ulcers. Clinical Features and Transmission: Symptoms of H. pylori include gastrointestinal upset, reflux and vomiting. Transmission of is by fecal oral route. CDC Recommends: Clinicians can screen for H. pylori-specific IgG as a useful marker for past or current infection, however a positive antibody screen should be confirmed by a second test (e.g., fecal antigen, urea breath test or endoscopy). Incidence: 70% of the world s population (40% of U.S. population) is currently infected with H. pylori (the world s most common infection). Buffer Vials Cassette Sample: Whole Blood, Serum and Plasma Sensitivity: 93% vs. Biopsy Specificity: 89.2% Test Time: mins. Expiration Dating: months Reimbursement: CPT 86318QW $18.22/test Mononucleosis Infectious Mononucleosis is an widespread disease caused by the Epstein-Barr virus Clinical Features and Transmission: Symptoms of infectious mononucleosis are fever, sore throat, and swollen lymph glands and occasionally swollen spleen or liver. Transmission of EBV requires contact with the saliva of an infected person. CDC Recommends: Clinicians and health officials tend to base the preliminary diagnosis of infectious mononucleosis on the basis of the symptoms of and the age of the patient. Rapid Testing at the point-of-care can be very useful in this circumstance. Laboratory tests are needed for confirmation. Incidence: In the United States 95% of adults between 35 and 40 years of age have been infected and ~40% of adolescents. Sample: Whole Blood, Serum and Plasma Sensitivity: >99.9% vs. Latex Agglutination Specificity: 98.6% Test Time: 5-10 mins Expiration Dating: months Reimbursement: CPT 86308QW $7.23/test 9

10 Influenza A+B (H1N1) Influenza outbreaks in the U.S. result in approximately 20,000 deaths and 200,000 hospitalizations annually. Clinical Features and Transmission: Influenza (the flu) is a contagious respiratory illness caused by influenza viruses. It can cause mild to severe illness and at times can lead to death. The elderly, young children and people with certain health conditions are at high risk for serious flu complications. Influenza A is the agent responsible for swine flu. CDC Recommends: Clinicians and health officials should encourage vaccination. Rapid Testing is useful to differentially diagnose specimens which should be sent for further testing. Incidence: In , a new and very different flu virus (called 2009 H1N1) spread worldwide causing the first flu pandemic in more than 40 years. During the flu season, the CDC anticipates the 2009 H1N1 virus to cause illness again along with other influenza viruses. Sample: Throat Swab + Nasal Aspirate Specificity: >97.9% and >99.9% (A & B) vs. Culture Accuracy: >91.6% and 99.2% vs. Market Competitors Test Time: 15 mins Expiration Dating: months Reimbursement: CPT 87804QW $16.08/test Influenza A+B (H1N1) A Closer Look October 3, 2010 April 30, 2011, 16,328 laboratory-confirmed influenza-associated hospitalizations and 310 laboratoryconfirmed influenza-associated deaths were reported to CDC. Strep A Test Kit Streptococcus A (Streptococcus pyogenes) Clinical Features and Transmission: Symptoms of GAS include fever, irritation of the throat and difficulty swallowing. GAS bacteria are spread through direct contact with mucus from the nose or throat of persons who are infected or through contact with infected wounds or sores on the skin. GAS can cause no illness, mild illness (strep throat/pharyngitis or a skin infection such as impetigo) or severe illness such as necrotizing faciitis. CDC Recommends: Clinicians and health officials should suspect Strep A in cases where sore throats last more than a week or difficulty swallowing. Incidence: Over 2 million cases of Strep throat annually. There are 1,000-1,800 GAS deaths annually with 10,000-15,000 cases in U.S. It is one of the most common infectious diseases worldwide. Sample: Throat Swab Sensitivity: 97% vs. Culture Specificity: 95% Test Time: 5 10 mins Expiration Dating: months Reimbursement: CPT 87880QW $16.88/test 10

11 Respiratory Syncytial Virus Clinical Features and Transmission: RSV is a seasonal respiratory virus that infects the lungs and breathing passages. Infections can be severe in infants, young children and older adults. RSV spreads when an infected person coughs or sneezes. CDC Recommends: Clinicians and health officials should suspect RSV as the most common cause of bronchiolitis and pneumonia in children under 1 year of age in the United States. RSV infections generally peak in the United States from November to April. Surveillance Trends: National Respiratory and Enteric Virus Surveillance System (NREVSS) thousand infants hospitalized in U.S. Sample: Nasopharyngeal Washes, Aspirates and Swabs Sensitivity: >94.1% Specificity: >95.6% Accuracy: >95% compared to culture Test Time: 15 mins Expiration Dating: months Reimbursement: CPT 87807QW $17.08/test CLIA WAIVED 2011 RSV Occurrence in Texas, LA, AR,OK Rotavirus Rapid Test Clinical Features and Transmission: Rotavirus infections cause vomiting and watery diarrhoea that may last from 3 to 8 days. Additional symptoms include loss of appetite and dehydration. The virus spreads by the fecal-oral route. CDC Recommends: Clinicians and health officials should suspect rotavirus infections in adults with diarrhoea who care for children, in older adults and in adults who are traveling. Children are most likely to present with rotavirus in the winter and spring (December through June). Surveillance Trends: National Respiratory and Enteric Virus Surveillance System (NREVSS). Sample: Fecal Specimens Sensitivity: >98% Specificity: >98% Accuracy: >97% compared to culture Test Time: 15 mins Expiration Dating: months Reimbursement: CPT CLIA MODERATE Adenovirus Rapid Test Clinical Features and Transmission: Adenoviruses most commonly cause acute respiratory disease; however, depending on the infecting serotype, they may also cause various other illnesses, such as gastroenteritis, conjunctivitis and cystitis (bladder infection). Ad14 serotype most virulent. Transmission is by direct contact, fecal-oral transmission, and occasionally waterborne transmission. CDC Recommends: Clinicians and health officials should consider Ad14 as a possible cause of severe pneumonia and of outbreaks of pneumonia for which the cause cannot otherwise be determined. Surveillance Trends: National Respiratory and Enteric Virus Surveillance System (NREVSS). U.S. OUTBREAKS: Alaska - late 2008 Washington mid 2007 Texas early 2007 Oregon - early 2007 New York City, May 2006 Sample: Human Eye Swabs, Nasopharyngeal Secretions, Fecal Sensitivity: >99.9% Specificity: >99.9% Test Time: 15 mins Expiration Dating: months Reimbursement: CPT CLIA MODERATE 11

12 1. In light of information presented would you consider screening for drug use amongst those patients with chronic pain? 2. In light of information presented would you consider screening using an immunochemical colorectal cancer rapid test? 3. In light of the information presents would you consider using a microalbumin / creatinine urine strip on patients whose samples are positive for protein? 12

13 4. In light of the information provided would you consider including an in-office rapid test screen for elevated TSH? 5. Do you believe your practice is currently generating the most income it can through reimbursement on patient testing? 13