Download S07 OTC In-Home Testing And Monitoring

In-Home testing and
Monitoring Products
FDA Approved:
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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:
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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 selfdiagnosing
Faecal Occult Blood Kits:
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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:
Faecal Occult Blood Kits:
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Haeme acts as oxidizing agent to
Tetramethylbenzidine
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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
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Faecal Occult Blood Kits:
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Factors Affecting the Test:
1.
Medications: e.g. aspirin, NSAIDS, steroid,
2.
Toilet Cleaners (false +ve)
Red meat (false +ve)
Vitamin C (false –ve; why?)
3.
4.
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.
Faecal Occult Blood Kits:
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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
Stimulates
Follicles to mature
LH
Promotes cells of graafian
follice to secrete progesterone
Promote midcycle LH surge
Secretes
Estradiol
Stimulates follicles
development
Promotes growth of
uterine endometruim
Maintain endometrial lining
Stimulates production of proteolytic enzymes
Ovulation Prediction &
Pregnancy Test Kits
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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
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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
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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
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Patient Counselling
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Use the same method and take temperature at
approx same time every morning (built-in alarm).
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The temperature should be taken just before
arising after at least 5 hours of sleep.
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Women who do not conceive for 3 consecutive
cycles may transmit data to manufacturer by
telephone.
Ovulation Prediction &
Pregnancy Test Kits
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Ovulation Prediction Kits:
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How Kits Work
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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.
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Ovulation Prediction Kits:
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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
Ovulation Prediction Tests
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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
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Factors That Affect Results:
1.
False +ve results maybe produced by:
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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:
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Saliva Ovulation kit:
Fertile
Infertile
(fern structures)
(Dry, clean)
OvuTest™ Saliva Fertility Prediction Microscope
A Precision 60X Pocket Microscope with automatic
light source Feature.
Home Pregnancy Tests
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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
Negative
Positive
Mechanism of Action
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
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Factors That Affect Results:
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This method is less susceptible to
interference by other substances.
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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
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Patient Counselling:
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Most tests today may be used at the day that
menses is due;
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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
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Not Only That!
Home Cholesterol Kits
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http://www.youtube.com/watch?v
=jkyEYwZlQsw
Home Blood Pressure
Monitoring Devices
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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.
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Home Blood Pressure
Monitoring Devices
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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);
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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
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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
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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
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Digital:
- quick, easy to use
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Drawbacks: -
inability of the user to
determine when device is out of
calibration
- many devices lack accuracy and
reliability
Home Blood Pressure
Monitoring Devices
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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
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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
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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
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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
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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 selfadjust 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
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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:
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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:
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all patients who require insulin
most patients who require drug therapy
Blood Glucose Tests:
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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).
1.
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Photometric/Colorimetric meter
Non-wipe/second-generation meter
Blood Glucose Tests:
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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:
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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:
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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:
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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:
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Glucose Oxidase Tests
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Glucose
Glucose oxidase
(strips):
Gluconic acid + H2O2
Colour change!!
 more convenient
 less expensive
X strips can’t be read easily
X strips are affected by humidity
O-toluidine
Drug Interferences
Tables 14, 15
Urine Glucose Tests:
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Substances that interfere with
glucose oxidase tests:
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False-positive: Chloride, Glucose
hypochlorite, Hydrogen peroxide,
Peroxide
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False-negative: Ascorbic acid, Aspirin,
Bilirubin, Cysteine, Epinephrine,
Levodopa, Methyldopa,
Urine Glucose Tests:
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Disadvantages of urine glucose tests
(Table
16):
1.
Inability to detect low blood sugar (hypoglycemia)
2.
Many possible drug interferences
3.
Patient variance with reference to renal threshold
for glucose
4.
For some patients, difficulty in reading and
performing tests
5.
More privacy required than blood testing
6.
Inability to detect how high blood glucose really is
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
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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
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
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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
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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.
Useful links:
www. Fda.gov/cdrh/oivd/consumerotcdatabase.html
 www.fda.gov/cdrh/oivd/consumerhomeuse.html
 www.Pharm.uky.edu/hometest/kitsh
p.htm
 www.fad.gov/cdrh/ode/otctable.html
 www.fda.gov/search/database.html
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