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Home Testing DevicesAnthony Pattin, PharmDClinical Assistant ProfessorWayne State UniversityPHA 4010 1ObjectivesDiscuss the rationale for each home diagnostic testIndentify patients who are appropriate candidates for using each testList the advantages and disadvantages of each test if they existDescribe the basic mechanism of action for each test

2ObjectivesKnow what factors might interfere with the results of a testKnow what recommendations to make based on a positive or negative test resultAsk appropriate questions and provide counseling to a patient considering using a test3Home testing devicesServes two basic purposes

Early detection of health conditionsMonitor health conditions

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bloodglucose-chart.comPrevention is where health care is going. Think about the ACA. The earlier we can detect and prevent disease, the more money we can save the health care system. Efforts are being developed to prevent unnecessary hospitalizations.

At Kroger we have a massive campaign going on right now to screen many employees for preventable illnesses, such as diabetes, heart attack and stroke. We are measuring blood sugar, blood pressure, cholesterol and weight. It is required in order to sign up for medical insurance. 4Point of care testing and pharmacyUS Prevention Services Task Force recommendations which are significant for pharmacy (Grade A and Grade B)-Blood Pressure Screening in adults ages 18 and over (A)-Cholesterol Abnormalities Screening (A-M/F> 35/45, B-M/F135/80mmhg)

Pharmacy Care Through the Use of Point of Care Testing. NACDS Regional Meeting; 2014Point of care testing and pharmacyOsteoporosis Screening (B-F>65 or younger women whose fracture risk is > that of a 65 year old white woman with no additional risk factorsObesity Screening (B-Adults and children with BMI>30 along with referral to comprehensive and intensive behavioral interventions)HIV Screening (A-nonpregnant adolescents and adults, pregnant females)Colorectal Cancer Screenings (A-50-75 years old)

Pharmacy Care Through the Use of Point of Care Testing. NACDS Regional Meeting; 2014Introduction95-98% accuratePermits proper use, regardless of intelligenceOffers quality control featuresSimple and easy instructionsProvides adequate warnings/precautionsLists all interfering substances, food or medications7RegulationFDA cleared= CLIA waivedCLIA- Clinical Laboratory Improvement amendments waved tests

We often need a CLIA waiver in a pharmacy, in order to operate point of care devices such as blood sugar meters, cholesterol machines

Defined as simple laboratory examinations and procedures that are cleared by the FDA for home use, and employ methodologies that are simple and accurate as to rend the likelihood of erroneous results negligible; or pose no reasonable risk or harm to the patient if the test is performed incorrectly8Patient assessment variables??????

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mirkabreen.blogspot.comAppropriateness of testingAbility to accurately conduct the test Ease of interpreting resultsPotential interference with test resultsCost

9Home test kits up for discussion

babymed.com

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testcountry.com

abicana.comPregnancy, female fertility, male fertilityMenopause, colorectal cancer, high cholesterolUrinary Tract Infection, HIV, Hepatitis C, Drug abuseBlood Pressure Monitors

10Female reproductive cycle

1.Cycle approx 28 days long2. At the beginning of cycle low levels of circulating estrogen/progesterone cause hypothalamus to secret GnRH (gonadotropin releasing hormone)3. GnRH stimulates the release of FSH (follicle-stimulating hormone) and low levels of luteinizing hormone (LH)4. This combination of hormones promotes development of several follicles within an ovary during each cycle.5. At mid cycle- a LH surge causes final maturation of the follicle.6. Ovulation (rupturing of follicle and release of ovum) this occurs 20-48 hours after LH surge7.Cells rupture and luteinize and form the corpus luteum- which begins to secret estrogen and progesterone (those are common female hormones)8. If fertilization occurs hCG (human chorionic gonadotropic hormone) is produced.

11Key points to rememberRise in ___________ causes final maturation of follicle

If fertilization occurs ______ (human chorionic gonadotropic hormone)12Pregnancy Detection TestsRational: Early detection of pregnancy enables a woman to make early decisions and choices regarding prenatal care, as well as lifestyle changes to avoid hard to the fetusReally important from the pharmacist standpoint. If the patient is pregnant, we want to ensure the patient is not on any potential teratogenic medications13Pregnancy Detection TestsSymptoms of early pregnancy- late/missed period, nausea, fatigue, and breast tenderness

http://www.getthelowdown.co.uk/body/missed-periods.aspx14How do they work?Use monoclonal or polyclonal antibodies with a chromogen active enzyme to detect the presence of human chorionic gonadotropin (HCG) present in the urine

homeopathic-hcg.wikidot.comImplantation begins ~5-6 days after fertilizationhCG can be detected in the blood ~ 5 days after implementationhCG becomes detectable in the urine within 1-2 weeks after fertilization

15AccuracyAdvertised as 99% effective if used correctlyStudies indicate really 50-75% effective because they are not used correctlyFalse positives: Miscarriage or given birth in the past 8 weeks, infertility injections such as Pergonal (menotropins) or Profasi (chorionic gonadotropin), test read after specified time window, unreliable results in patients in ovarian cysts or ectopic pregnancy (hCG still detectable)

16AccuracyFalse negatives: Test performed on or before the day of missed periodContaminated sample (wax paper cups)Problematic PregnancyPatient should retest in 1 week to confirm results if menstruation has not begunTesting too earlyNOTE: Oral contraceptives do NOT interfere with the test17Considerations when choosing a testPreference for stick or cassette formHow are the results reported? (lines or say pregnant- does it give digital reading)Presence of a controlCost- early detections tests are more expensiveHow late is the woman?18Key CounselingKeep in mind emotional issues of patient, ensure privacyMost tests say you can test as soon as 1 day after missed period- if you test too early may get false negativeMore likely to have a true positive if you wait until a woman has missed her periodKeep in mind emotional issues of patient, ensure privacyMost tests say you can test as soon as 1 day after missed period- if you test too early may get false negativeMore likely to have a true positive if you wait until a woman has missed her period

19Key counselingDilution of Urine: The first morning urine will have the highest concentration of hCGMost manufacturers say a random sample can be used for most tests: If random testing- the woman should not drink anything for 4 to 6 hours before urinatingRead the directions before doing anything!20What to do with test resultsIf positive- the women should contact her family physician or OB/GYN also get prenatal vitaminsIf negative and STILL no period- repeat the test in 1 week- let the hormone build upIf second test is still negative after 1 week and still no period- she should seek advice of health care provider21Female fertility testRationale- to determine when a woman is ovulating so that couples can time their intercourse with optimal fertility, increase the chance of contraception22Definition of infertilityClassic definition: Young couple, frequent intercourse.. Inability to conceive after 1 year of trying, 85% of couples will get pregnant within 1 year, 93% within 2 years of tryingCurrent definition: if female is under 35 yo, infertile after 1 year of trying and greater than 35 infertile after 6 months23Basal Thermometry

justmommies.comBasal body temperature (BBT)- temperature of the body at restDuring the first part of a womans cycle the BBT is below normalAfter ovulation there is a slight rise in BBT- it can take ~24 hours after ovulation for the temperature to riseThis change in minimal- only 0.4-0.6 degrees

24Basal ThermometryRectal, vaginal, or oral temperature taken each morningShould be done each first thing each morning; need to be the same timePatient must plot temperature reading on graphsA consistent rise in temperature signals ovulation has occurred25AccuracyRecording and charting temperatures may be challengingThermometers have small graduations and are often difficult to read may need digital Small increase in temperature

http://www.iconarchive.com/show/influenza-icons-by-cute-little-factory/Thermometer-icon.html26Urine hormone testsUse monoclonal antibody specific to luteinizing hormone (LH) to detect surge in LHLH is normally present a t low levels throughout the menstrual cycle and can be detected in the urineJust prior to ovulation the level of LH rises rapidly and sharply LH surgeOvulation generally occurs 24-48 hours after LH surge

27Urine hormone testsViability of ovum for fertilization is 12-24 hours while the viability of sperm is 72 hours (some can like up to 5 daysGreatest chance of fertilization is 2 days before, the day of, and the day after ovulationIntercourse should take place ASAP once LH surge is detected and for the next several daysIncrease number of acts increase chance or pregnancy28Saliva electrolyte microscopesBackground: hormone changes affect saliva composition which changes dried saliva patternsPut saliva on a slide and allow to air dry and then examine the appearanceA fern-like pattern appear 3-4 days before and persists for 2-3 days after ovulation29

Fertile periodNot fertileContraception possible30Saliva electrolyte microscopesSmoking, alcohol, eating, and anticholinergic drugs can affect the quality of salivaPolycystic ovary disease, peri-menopause may interfere as wellPatient counseling: Do not brush teeth, smoke, drink, or eat within 2 hours of testingTest daily to get a clear picture of what the change is31Male fertility TestsMeasure sperm countBelow 20 million sperm per milliliter indicated low sperm countSperm count is only a factor in fertilityAccuracy of test is 78%32Fecal occult blood testsBackground: rectal bleeding is an early and common symptom of colorectal cancer- the second leading cause of cancer deathFOB- the presence of blood in the stool too small to be seen without chemical testingWhen diagnosed at an early stage the 5 year survival rate approaches 90%33Fecal Occult blood testsAmerican Cancer Society colorectal screening guidelines:Beginning at age 50, both men and women should follow one of the screening options belowAnnual FOBT plus sigmoidoscopy every 5 yearsFlexible sigmoidoscopy every 5 yearsAnnual FOBT (take home multiple sample recommended Double contrast barium enema every 5 yearsColonoscopy every 10 years34Fecal Occult blood testsIn home test detect blood in fecesTest reagent changes blue green color35Interferences to FOBTOther conditions that cause blood to appear in stool: Ulcers, Crohns disease, colitis, hemorrhoidsMenstrual blood in the toilet water (menstruating women should wait)Drugs that cause GI bleeding: ASA, NSAIDs, steroids, warfarin- Vitamin C may cause false positiveNot specific for human blood so red meat can cause false positiveToilet bowl cleaners may cause false positive36Fecal occult blood testPatient education: Follow directions exactlyAvoid things known to cause false positiveEat food high in fiber to stimulate any GI lesions to bleedIf using toilet bowl method, urinate and flush before performing testsRecommend annual testing, negative test does not mean NO cancer is present- follow recommendations37Urinary tract infection test kitsSymptoms of an UTI include: Pain on urination, feeling an urgent need to urinate, urinary frequency, blood in urine, lower abdominal pain or discomfort80% of UTIs are cause by E. coli

Proper use includeEarly detection of UTIs in patient with history of recurrent UTIs Health care provider wants to confirm that infection is cured38Urinary tract infections test kitsTwo different mechanisms of actions:

Nitrite- urinary nitrate is converted to nitrite by the enzyme nitrate reductase in many gram negative bacteriaLeukocyte esterase (LE)- enzyme is unique to WBC therfore it is an indicator of pyria which can occur if infection is present39accuracyLow sensitivity (45%-60%) and high specificity (85%-98%)Interferences include:Strict vegetarian diet provides low urinary nitrates- cause false negativeVitamin C in excess of 250mg may cause false negative because blocks testItems that change urine red/orange (pyridium)Menstrual blood

40Patient educationClean the urogenital area before doing the testTest with the morning urine on 3 consecutive days (or urine has been help in bladder at least 4 hours)Use midstream catchIf result is positive- contact healthcare providerIf result it negative but symptoms are present- contact healthcare provider

41Human Immunodeficiency Virus-1 TestMore than 50,000 new cases of HIV infection occur each year in the USAn estimated 21% of persons with HIV are undiagnosedHome HIV-1 tests allow a person to test for HIV in privacy42Hiv-1 TestingPeople are at riskShare needlesSexual intercourseBlood transfusion between 1978 and May 1985Born to mother with HIV

cheaphealthinsurance.term.org43How do they work?Detect antibodies to the virus

The time since possible exposure must be considered in determining when to perform a test

After collection, the home HIV-1 test samples are mailed to a certified laboratoryProblem, is there has to be enough antibodies, in order for this to be detectable. Usually wait 3 months.This particular mail service has 2 kinds. You have the Home Access (7 days) and Home Access Express (3 days). 44The First in-home oral hiv test

OTC OraquickGives results in little as 20 minutesUse a swab to get oral fluid sample, place in vial of solutionIn 20-40 minutes the device gives one line for negative, and two lines for positive resulthttp://pharmacistsletter.therapeuticresearch.com/ce/ceNewsletter.aspx?nidchk=1&cs=cp&s=PL&is=092012&vo=6&ceid=KMI-PATTINA560246Hepatitis c One of 6 identified hepatitis virusesRisk factors include: -injection use of drugs -long-term hemodialysis -transfusion/organ transplantation before 1992 -sexual intercourse with many partners -birth by a mother infected with the virus47Hepatitis CCDC recommends individuals born between 1945 and 1965 should receive one-time testing for HCV- Of 32 million individuals infected with the virus in the US, 75% were born in this timeframeHepatitis CMechanism of Actions: detect antibodies to HCVItems to considerHome testing devices are being use in the pharmacy as tools to improve patient outcomesKeep up to date on new tests, the market is exploding with these devices and technology is rapidly evolvingMake sure to keep CLIA waiver up to date for your pharmacies (or that someone is handling this for you)