Home Testing Devices

Anthony Pattin, PharmD

Clinical Assistant Professor
Wayne State University
PHA 4010

OBJECTIVES

Discuss the rationale for each home

diagnostic test
Indentify patients who are appropriate
candidates for using each test
List the advantages and disadvantages
of each test if they exist
Describe the basic mechanism of action
for each test

OBJECTIVES

Know what factors might interfere with

the results of a test
Know what recommendations to make
based on a positive or negative test
result
Ask appropriate questions and provide
counseling to a patient considering
using a test

HOME TESTING DEVICES

1.
2.

Serves two basic purposes

Early detection of health conditions
Monitor health conditions

http://www.visitwembleyvisitbrent.com/brent-for/offers.aspx

bloodglucose-chart.com

POINT OF CARE TESTING AND

PHARMACY

US 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/F<35/45)
-Diabetes Screening (B-asymptomatic adults
whose sustained blood pressure
>135/80mmhg)

macy Care Through the Use of Point of Care Testing. NACDS Regional Meeting; 20

POINT OF CARE TESTING AND

PHARMACY

Osteoporosis Screening (B-F>65 or younger

women whose fracture risk is > that of a 65 year
old white woman with no additional risk factors
Obesity 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)

macy Care Through the Use of Point of Care Testing. NACDS Regional Meeting; 20

INTRODUCTION

95-98% accurate
Permits proper use, regardless of
intelligence
Offers quality control features
Simple and easy instructions
Provides adequate
warnings/precautions
Lists all interfering substances, food or
medications

REGULATION

FDA cleared= CLIA waived

CLIA- Clinical Laboratory Improvement
amendments waved tests

PATIENT ASSESSMENT VARIABLES

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mirkabreen.blogspot.com kevinvaneck.wordpress.com

HOME TEST KITS UP FOR

DISCUSSION

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abicana.com

FEMALE REPRODUCTIVE CYCLE

KEY POINTS TO REMEMBER

Rise in ___________ causes final

maturation of follicle

If fertilization occurs ______ (human

chorionic gonadotropic hormone)

PREGNANCY DETECTION TESTS

Rational: 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 fetus

PREGNANCY DETECTION TESTS

Symptoms of early pregnancy- late/missed

period, nausea, fatigue, and breast tenderness

http://www.getthelowdown.co.uk/body/missed-periods.aspx

HOW 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.com

ACCURACY

Advertised as 99% effective if used correctly

Studies indicate really 50-75% effective
because they are not used correctly
False 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)

ACCURACY

False negatives: Test performed on or

before the day of missed period
Contaminated sample (wax paper cups)
Problematic Pregnancy
Patient should retest in 1 week to confirm
results if menstruation has not begun
Testing too early
NOTE: Oral contraceptives do NOT
interfere with the test

CONSIDERATIONS WHEN CHOOSING A TEST

Preference for stick or cassette form

How are the results reported? (lines or say
pregnant- does it give digital reading)
Presence of a control
Cost- early detections tests are more
expensive
How late is the woman?

KEY COUNSELING

Keep in mind emotional issues of

patient, ensure privacy
Most tests say you can test as soon as
1 day after missed period- if you test
too early may get false negative
More likely to have a true positive if
you wait until a woman has missed her
period

KEY COUNSELING

Dilution of Urine: The first morning

urine will have the highest
concentration of hCG
Most 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
urinating
Read the directions before doing
anything!

WHAT TO DO WITH TEST RESULTS

If positive- the women should contact

her family physician or OB/GYN also
get prenatal vitamins
If negative and STILL no period- repeat
the test in 1 week- let the hormone
build up
If second test is still negative after 1
week and still no period- she should
seek advice of health care provider

FEMALE FERTILITY TEST

Rationale- to determine when a woman

is ovulating so that couples can time
their intercourse with optimal fertility,
increase the chance of contraception

DEFINITION OF INFERTILITY

Classic 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 trying
Current definition: if female is under 35
yo, infertile after 1 year of trying and
greater than 35 infertile after 6 months

BASAL THERMOMETRY

justmommies.com

BASAL THERMOMETRY

Rectal, vaginal, or oral temperature

taken each morning
Should be done each first thing each
morning; need to be the same time
Patient must plot temperature reading
on graphs
A consistent rise in temperature signals
ovulation has occurred

ACCURACY

Recording and charting temperatures

may be challenging
Thermometers have small graduations
and are often difficult to read may
need digital
Small increase in temperature

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actory/Thermometer-icon.html

URINE HORMONE TESTS

Use monoclonal antibody specific to

luteinizing hormone (LH) to detect surge in LH
LH is normally present a t low levels
throughout the menstrual cycle and can be
detected in the urine
Just prior to ovulation the level of LH rises
rapidly and sharply LH surge
Ovulation generally occurs 24-48 hours after
LH surge

URINE HORMONE TESTS

Viability of ovum for fertilization is 1224 hours while the viability of sperm is
72 hours (some can like up to 5 days
Greatest chance of fertilization is 2
days before, the day of, and the day
after ovulation
Intercourse should take place ASAP
once LH surge is detected and for the
next several days

SALIVA ELECTROLYTE MICROSCOPES

Background: hormone changes affect

saliva composition which changes dried
saliva patterns
Put saliva on a slide and allow to air dry
and then examine the appearance
A fern-like pattern appear 3-4 days
before and persists for 2-3 days after
ovulation

Not fertile

Contraception possible

Fertile period

SALIVA ELECTROLYTE MICROSCOPES

Smoking, alcohol, eating, and

anticholinergic drugs can affect the
quality of saliva
Polycystic ovary disease, perimenopause may interfere as well
Patient counseling: Do not brush teeth,
smoke, drink, or eat within 2 hours of
testing
Test daily to get a clear picture of what
the change is

MALE FERTILITY TESTS

Measure sperm count

Below 20 million sperm per milliliter
indicated low sperm count
Sperm count is only a factor in fertility
Accuracy of test is 78%

FECAL OCCULT BLOOD TESTS

Background: rectal bleeding is an early

and common symptom of colorectal
cancer- the second leading cause of
cancer death
FOB- the presence of blood in the stool
too small to be seen without chemical
testing
When diagnosed at an early stage the
5 year survival rate approaches 90%

FECAL OCCULT BLOOD TESTS

American Cancer Society colorectal

screening guidelines:
Beginning at age 50, both men and
women should follow one of the
screening options below
Annual FOBT plus sigmoidoscopy every 5 years
Flexible sigmoidoscopy every 5 years
Annual FOBT (take home multiple sample
recommended
Double contrast barium enema every 5 years
Colonoscopy every 10 years

FECAL OCCULT BLOOD TESTS

In home test detect blood in feces

Test reagent changes blue green color

INTERFERENCES TO FOBT

Other conditions that cause blood to appear in

stool: Ulcers, Crohns disease, colitis, hemorrhoids
Menstrual blood in the toilet water (menstruating
women should wait)
Drugs that cause GI bleeding: ASA, NSAIDs,
steroids, warfarin- Vitamin C may cause false
positive
Not specific for human blood so red meat can
cause false positive
Toilet bowl cleaners may cause false positive

FECAL OCCULT BLOOD TEST

Patient education: Follow directions exactly

Avoid things known to cause false positive
Eat food high in fiber to stimulate any GI
lesions to bleed
If using toilet bowl method, urinate and
flush before performing tests
Recommend annual testing, negative test
does not mean NO cancer is presentfollow recommendations

URINARY TRACT INFECTION TEST

KITS

Symptoms of an UTI include: Pain on

urination, feeling an urgent need to urinate,
urinary frequency, blood in urine, lower
abdominal pain or discomfort
80% of UTIs are cause by E. coli

Proper use include

1. Early detection of UTIs in patient with history of
recurrent UTIs
2. Health care provider wants to confirm that
infection is cured

URINARY TRACT INFECTIONS TEST

KITS

Two different mechanisms of actions:

Nitrite- urinary nitrate is converted to

nitrite by the enzyme nitrate reductase
in many gram negative bacteria
Leukocyte esterase (LE)- enzyme is
unique to WBC therfore it is an
indicator of pyria which can occur if
infection is present

ACCURACY
Low sensitivity (45%-60%) and high
specificity (85%-98%)
Interferences include:
1. Strict vegetarian diet provides low urinary
nitrates- cause false negative
2. Vitamin C in excess of 250mg may cause
false negative because blocks test
3. Items that change urine red/orange
(pyridium)
4. Menstrual blood

PATIENT EDUCATION

Clean the urogenital area before doing

the test
Test with the morning urine on 3
consecutive days (or urine has been
help in bladder at least 4 hours)
Use midstream catch
If result is positive- contact healthcare
provider
If result it negative but symptoms are
present- contact healthcare provider

HUMAN IMMUNODEFICIENCY VIRUS1 TEST

More than 50,000 new cases of HIV

infection occur each year in the US
An estimated 21% of persons with HIV
are undiagnosed
Home HIV-1 tests allow a person to test
for HIV in privacy

HIV-1 TESTING

People are at risk

Share needles
Sexual intercourse
Blood transfusion between 1978 and
May 1985
Born to mother with HIV

heaphealthinsurance.term.org

HOW 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
laboratory

THE FIRST IN-HOME ORAL HIV TEST

OTC ORAQUICK

Gives results in little as 20 minutes

Use a swab to get oral fluid sample,
place in vial of solution
In 20-40 minutes the device gives one
line for negative, and two lines for
positive result

http://pharmacistsletter.therapeuticresearch.com/ce/ceNewsl
etter.aspx?nidchk=1&cs=cp&s=PL&is=092012&vo=6&ceid=KMI-PATT

HEPATITIS C

One of 6 identified hepatitis viruses

Risk 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 virus

HEPATITIS C
CDC 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 timeframe

HEPATITIS C

Mechanism of Actions: detect

antibodies to HCV

ITEMS TO CONSIDER

Home testing devices are being use in

the pharmacy as tools to improve
patient outcomes
Keep up to date on new tests, the
market is exploding with these devices
and technology is rapidly evolving
Make sure to keep CLIA waiver up to
date for your pharmacies (or that
someone is handling this for you)