In-Home testing and Monitoring Products

FDA Approved: Pregnancy tests Blood glucose Ovulation predictor tests Male infertility tests UTI tests Cholesterol tests HIV tests Hepatitis C tests Fecal occult blood tests Drug abuse tests Menopause tests Vaginal pH tests Prothrombin time tests

General Guidelines to Use Home Test Kits: Follow instructions for storage and check up Exp. Date. Read instructions carefully before test (best time of day, duration of test, any necessary equipment) Use accurate time measuring device (seconds) No visual impairment Consult with Dr. or pharmacist Important: patients are self-testing not self-diagnosing Product Selection Guidelines: Complexity of test procedure Ease of reading results Presence of control Cost

Faecal Occult Blood Kits: Adjunct to more invasive tests to detect any GIT bleeding Best known use: home screening for colorectal cancer Occult blood: - on surface (lower GIT) - in matrix (upper GIT) How the kit works - Colorimetric assay of haemoglobin

Faecal Occult Blood Kits: Haeme acts as oxidizing agent to Tetramethylbenzidine Produces blue-green colour (+ve test) The reagent is sandwiched between two biodegradable papers and is placed in the toilet bowl after a bowel movement

Faecal Occult Blood Kits: Factors Affecting the Test: Medications: e.g. aspirin, NSAIDS, steroid, D/C at least 2-3 days before test - Rectal medications should also be avoided - Patients should consult with their Dr. before D/C of a Rx medicine. Toilet Cleaners (false +ve) Red meat (with ColoCARE; false +ve) Vitamin C (false –ve; why?)

Faecal Occult Blood Kits: Patient Consultation: Test should not be performed during periods of “known” bleeding Dietary fibres should be increased several days before test Cancerous bleeding is intermittent (i.e. test 3 consecutive bowel movements) Screening test and not particular for a specific disease. (e.g. oesophageal varices, ulcer, haemorrhoids, polyps, diverticulitis)

Female Reproductive Cycle Low levels of estradiol & progestrone Hypothalamus GnRH inhibit Anterior Pituitary FSH LH Stimulates Follicles to mature Promotes cells of graafian follice to secrete progesterone Promote mid-cycle LH surge Secretes Estradiol Maintain endometrial lining Stimulates follicles development Stimulates production of proteolytic enzymes Promotes growth of uterine endometruim

Ovulation Prediction & Pregnancy Test Kits Female Reproductive Cycle (pp.35) Ovulation Prediction Tests: Basal Thermometry After ovulation, basal body temperature rises to level closer to normal (370 C) Women who use this method take their temperature (rectally, orally or vaginally) each morning before arising and plot it graphically.

Ovulation Prediction & Pregnancy Test Kits Choosing a Test Some women have difficulty is reading the mercury thermometer especially that increase is small (0.2-0.60C) The Bioself Fertile Indicator uses computer technology, provide digital temperature reading in just 2 minutes, stores readings in memory for up to 120 days, calculate cycle length and predict most fertile days.

Ovulation Prediction & Pregnancy Test Kits The Bioself Fertile Indicator has light indicators: Green: conception not possible ‘safe period’ Red: conception is possible Flashing Red: most fertile period ‘unsafe’ Factors That Affect Results: Eating, Drinking, Smoking, Emotions, Movements, Talking, Infections.

Bioself Fertility Indicator

Ovulation Prediction & Pregnancy Test Kits Patient Counselling Use the same method and take temperature at approx same time every morning (built-in alarm). The temperature should be taken just before arising after at least 5 hours of sleep. Women who do not conceive for 3 consecutive cycles may transmit data to manufacturer by telephone.

Ovulation Prediction & Pregnancy Test Kits Ovulation Prediction Kits: How Kits Work Detect LH surge LH surge in serum: 20-48 hrs before ovulation, then appears in urine 8-12 hrs after. Monoclonal AB specific to LH and an ELISA to elicit colour change indicative of the amount of LH in urine.

Ovulation Prediction Kits: The ClearPlan Easy Fertility Monitor High specificity: LH + E3G test sticks  A palm size monitor Lady should establish a baseline data about her hormone level fluctuations (20 days at first) starting the 6th day after menstruation Then 10-20 days each month Results: low, high, peak High= high chance of fertility 1-5 days leading to the peak reading ‘peak’= highest chance of conception, usually 2 days before ovulation What is E3G? E3G is produced when estrogen breaks down in the body. It accumulates in urine around the time of ovulation and causes the cervical mucus to become thin and slippery. Sperm may swim more easily in thin and slippery cervical mucus, increasing your chances of getting pregnant.

Ovulation Prediction Tests Once ovulation occurs, the ovum remains viable for fertilisation for 12-24 hours. The sperm may live up to 72 hours, the optimal days for fertilization are the 2 days before ovulation, the day of ovulation, and the day after ovulation. Once LH surge is detected > stop testing. If the LH surge is not detected (3 reasons): For the greatest chance of achieving pregnancy, intercourse should take place within 24 hours after the LH surge.

Ovulation Prediction Tests Once LH surge is detected > stop testing. If the LH surge is not detected (3 reasons): The test was not performed correctly There was no ovulation The test was used too late in the cycle These products should not be used more than 3 months. If a woman has not conceived, the doctor should be consulted.

Ovulation Prediction Tests Factors That Affect Results: False +ve results maybe produced by: menotropins (LH levels are elevated artificially) menopause and polycystic ovary syndrome (High LH levels) Recent pregnancy, breast feeding The true LH surge can be detected in patients receiving clomiphene, after 2 days of D/C drug. Oral Contraceptive Pills (OCPs) delay ovulation 1-2 cycles

NEW Home Diagnostic Kits: Saliva Ovulation kit: Infertile (Dry, clean) Fertile (fern structures)

Crystallization Days 4-6 Days 7-9 OvuTest™ Saliva Fertility Prediction Microscope A Precision 60X Pocket Microscope with automatic light source Feature. Least Fertile Not Fertile Fertile-Most Fertile                                                             Menstruation 3-7 Days Dry Days 0-3 Crystallization Days 4-6 Days 7-9 Dry Days 11-14

Home Pregnancy Tests How Kits Work: - Detect HCG in urine 1-2 weeks after conception Previously: Haemagglutination inhibition reaction > many limitations. Today: Mono/Polyclonal antibodies in an enzyme immunoassay

Mechanism of Action HCG chromogen enzyme AB HCG AB AB AB AB AB AB AB AB AB Wait 1-5 minutes then read result (according to instructions) urine

Home Pregnancy Tests Factors That Affect Results: False –ve results: This method is less susceptible to interference by other substances. False –ve results: If test was used too soon after conception If urine was refrigerated and not allowed to return to room temperature

Home Pregnancy Tests Patient Counselling: Most tests today may be used at the day that menses is due; Generally, the 1st morning, urine samples are collected; Use provided containers (not waxed containers); Test urine immediately; If test +ve > pregnant > see Dr. If test –ve > repeat test > see Dr. if still no menses

Home Cholesterol Kits http://www.youtube.com/watch?v=jkyEYwZlQsw

Home Blood Pressure Monitoring Devices How devices work: 3 categories of monitor for home use: mercury column aneroid Digital - Mercury column and aneroid meters involve auscultation using a stethoscope to detect korotkoff’s sounds.

Home Blood Pressure Monitoring Devices Digital meters: has oscillometric sensors that detect blood surges beneath cuff; Phase I of korotkoff’s sounds > systolic BP (at least first 2 consecutive beats heard after deflation); Diastolic BP is identified by phase V, the disappearance of the sound. If cuff size is too small > significant overestimation of BP.

Home Blood Pressure Monitoring Devices Choosing a Device: No device is best for every patient, choice depends on ability of pt to learn, physical handicaps, economic status and preference. Mercury column: most accurate and reliable but cumbersome for home use and carries danger of mercury toxicity.

Home Blood Pressure Monitoring Devices Aneroid Device: option of choice for home use. light, portable, v affordable, no toxicity. Built-in stethoscope, gauge attached to inflatable bulb.

Home Blood Pressure Monitoring Devices Digital: - quick, easy to use Drawbacks: - inability of the user to determine when device is out of calibration - many devices lack accuracy and reliability

Home Blood Pressure Monitoring Devices Proper Technique of BP Measurement: room should be at comfortable temperature Chair should be comfortable, with back supported and feet straight ahead and flat on the floor Arm should be supported with mid point of upper arm at heart level Remove restricting clothing from arm Cuff should be snug but not tight.

Home Blood Pressure Monitoring Devices Have the patient rest at least 5 minutes in this position Measure BP Take 2-3 measurements separated by at least 2 minutes at the same arm Record the results including: time and date of measurement, any medications that pt is taking and time of last dose of each Supply results to primary care provider

Home Blood Pressure Monitoring Devices Factors That Affect Results: The most common error among doctors is failure to use the correct cuff size; Holding the arm higher or lower the heart can also affect reading.

Home Blood Pressure Monitoring Devices Patient Counselling: Pharmacist should help pt choose the correct device and train him/her on its usage. Advise patient: avoid smoking and caffeine at least 30 minutes prior to measurement. Also wait 15 minutes after bath, and 30 minutes after eating (decrease BP)

Home Blood Pressure Monitoring Devices Patient should be relaxed and not pressured by time (BP will be elevated). The patient’s communication with health care providers regarding antihypertensive therapy should be facilitated. Patients should be cautioned not to self-adjust medications on basis of home measurements unless instructed by Dr.

Blood & Urine Testing in Diabetes Mellitus Glucose Blood Urine Ketones Urine (for IDDM patients, whenever blood glucose level > 200-250 mg/dL)

Blood & Urine Testing in Diabetes Mellitus Essential especially for patients who take insulin and need to adjust the dose according to test results. Insulin level should never be adjusted based on urine glucose Urine glucose indicates only that there was a blood glucose increase (but not a decrease) in the past hours and that glucose spilled over in the urine when blood glucose level exceeded the threshold (which differs from one person to another).

Blood Glucose Tests: Benefits of tight glucose control: Frequent checking will motivate patients to maintain their blood glucose level within normal range; Encourage patients to be more involved in their dietary control; Facilitates proper insulin dosage, and allows dosage to be adjusted with confidence; Abnormal blood glucose levels are normalised more quickly.

Blood Glucose Tests: Maintenance of blood glucose control is impossible without measurement; Self-Monitoring of blood glucose (SMBG) is the most accurate method a patient can use. SMBG is recommended for: all patients who require insulin most patients who require drug therapy

Blood Glucose Tests: Glucose Meters: Gives a “specific” blood glucose level rather than a range. 2 types of meters, both are based on oxidation (using glucose oxidase or hexokinase activity). Photometric/Colorimetric meter Non-wipe/second-generation meter

Blood Glucose Tests: Non-wipe meter (second generation) measures blood glucose through an electronic charge via a chemical reaction Blood on strip not blotted- remains outside meter An electrical impulse is transmitted into the meter for assessment by system/computer chip.

Blood Glucose Tests: All meters are calibrated, thus will analyse blood glucose levels based on programmed data; Provide a digital readout and visual indicator; some have audio components; Several have memories for later recall of recent blood glucose levels.

Blood Glucose Tests: According to FDA: when meter is used properly, calibrated frequently and interpreted correctly > accuracy±10% Lancets and other Accessories: Lancet, lancet holders, alcohol swap, cotton balls, alcohol Considerations: use side of finger, wash with warm water, make sure alcohol has evaporated before lancing finger.

Urine Glucose Tests: SMBG is preferred, but urine testing is recommended for those who cannot or will not monitor their own blood glucose: Patients who refuse to lance themselves Patients who can’t be taught the proper technique or are otherwise, unreliable.

Urine Glucose Tests: Glucose Oxidase Tests (strips): more convenient Glucose Gluconic acid + H2O2 more convenient less expensive X strips can’t be read easily X strips are affected by humidity Glucose oxidase O-toluidine Colour change!! Drug Interferences Tables 14, 15

Urine Glucose Tests: Substances that interfere with glucose oxidase tests: False-positive: Chloride, Glucose hypochlorite, Hydrogen peroxide, Peroxide False-negative: Ascorbic acid, Aspirin, Bilirubin, Cysteine, Epinephrine, Levodopa, Methyldopa,

Urine Glucose Tests: Disadvantages of urine glucose tests (Table 16): Inability to detect low blood sugar (hypoglycemia) Many possible drug interferences Patient variance with reference to renal threshold for glucose For some patients, difficulty in reading and performing tests More privacy required than blood testing Inability to detect how high blood glucose really is

Factors in Selection of Test Products Diabetes Category Patients whose blood glucose is unstable/ take insulin need to test more often Patient’s ability and motivation - use simpler tests for patients unable to perform even if such tests are not as quantitaive Physical Handicaps: Clinitest urine testing and several SMBG systems can’t be used by patients with trembling hands; Patients with poor vision: difficulty to see colour or meter readout > special kits for visually impaired patients > or meters with audio components

NEW Home Diagnostic (collection) Kits: Home Test Kit for “HIV” Main advantage is to keep anonymity of the patient. Method: prick finger with disposable lancet> blood absorbed by special paper with special ID number > mail> tested using standard lab screening > call a toll-free number and report ID number > get result, counselling and referral

Drugs of Abuse Testing

Personal Forensic Drug of Abuse Hair Analysis                         FDA approved In-home testing kit The PDT-90 personal forensic hair analysis drug of abuse testing service is the only at home drug testing kit that provides a *history (up to several months) of current or previous drug use for the five most abused illicit drugs and drug categories: Methamphetamines, Marijuana, Opiates, Cocaine and Phencyclidines (PCP) without the need for urine specimen collection. The only sample required is a small lock of the test subject's hair (approximately the size of a shoelace tip) taken at the scalp line. Confidential and non-invasive, The PDT-90 drug test provides a quantitative determination of past drug use over a period of approximately three (3) months using forensic laboratory analysis. The PDT-90 hair test is FDA cleared for professional and personal home use. provides a *history (up to several months) of current or previous drug use for the five most abused illicit drugs and drug categories: Methamphetamines, Marijuana, Opiates, Cocaine and Phencyclidines (PCP) without the need for urine specimen collection

Personal Forensic Drug of Abuse Testing Service Normal growth rates for human hair are approximately one-half inch per month. By testing for the presence of drugs at various levels in the hair shaft core on a given length of hair, a fairly accurate approximation can then be made as to how long a particular drug has been used historically.

Personal Forensic Drug of Abuse Testing Service trace amounts of the target drug or drug metabolite are deposited in the hair follicle and become entrapped in the core of the hair shaft as it grows out from the hair follicle. The presence of drugs in hair is based on a simple principle. Drugs which are ingested into the body circulate in a person's bloodstream which nourishes developing hair follicles.  As a result, trace amounts of the target drug or drug metabolite are deposited in the hair follicle and become entrapped in the core of the hair shaft as it grows out from the hair follicle. Normal growth rates for human hair are approximately one-half inch per month. By testing for the presence of drugs at various levels in the hair shaft core on a given length of hair, a fairly accurate approximation can then be made as to how long a particular drug has been used historically. Since target drug or drug metabolite residues are chemically and structurally stable for a period of time, they cannot be easily washed, bleached or flushed out of the hair structure. Consequently there is little possibility of sample contamination or manipulation. Gas chromatography/mass spectrometry (GC/MS)  forensic laboratory analysis of the hair shaft from an individual can achieve highly accurate drug test results and provide a historical use record. Generally it takes approximately 5 days for drugs to show up in a person's hair and will continue to be detectable in new hair growth for several months.

Useful links: www. Fda.gov/cdrh/oivd/consumer-otcdatabase.html www.fda.gov/cdrh/oivd/consumer-homeuse.html www.Pharm.uky.edu/hometest/kitshp.htm www.fad.gov/cdrh/ode/otctable.html www.fda.gov/search/database.html