Lecture 21: Home testing & Monitoring Devices Flashcards
(80 cards)
Home diagnostic market is motivated by:
○ Increased public interest in health and preventive medicine
○ Reduced health care costs
○ Reduced access and availability of health care resources
○ Increased number of available tests
○ Important technology advances → simple, accurate tests
Regulation
● FDA requires that tests are as accurate as professional use
equivalent
● CAVEAT: Test must be used correctly
General Considerations with OTC Testing
● Ensure the product is FDA approved: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIVD/Search.cfm ● Check the expiration date ● Follow directions for storing ● Consider simplicity of use ● Consider cost
General Counseling Points
● Read all instructions carefully
● Make sure you have enough time and all the supplies to complete the
test
● Use an accurate timing device
● Use an area with good lighting if looking for a color change
Sensitivity
ability to correctly identify people who have the disease
○ Ability to identify TRUE POSITIVE
○ Highly sensitive = low rate of false negatives
○ A nonsensitive test would identify no one as
having the disease
Specificity
ability to correctly rule out those who do NOT have the disease
○ Ability to identify TRUE NEGATIVE
○ Highly specific = low rate of false positives
○ A nonspecific test would identify everyone
as having the disease
Sensitivity and specificity are
they are inversely related
Sensitivity and specificity are valued differently for different tests
○ What would you categorize the following - more specific or more sensitive?
■ Airport bag x-ray screeners?
○ Would you prefer a test be more sensitive or more specific if testing for….
■ COVID antigen test?
■ COVID antibody test?
■ Cancer diagnostic test?
How sensitive is the test
How many actually-pregnant women does it correctly identify as pregnant?
How specific is the test?
How many not-pregnant women does it correctly confirm as not-pregnant?
What is the false-negative rate?
How many women who were pregnant were told they weren’t
What is the false-negative rate?
How many women who weren’t actually pregnant
Pregnancy Test (review)
● Detects human chorionic gonadotropin (HCG) in urine
● May work as early as 3-4 days prior to missed period
● VERY accurate starting at day of missed period
○ If taken too early it may result in a “false negative”
● Highly specific test
○ Low rate of false positives
Pregnancy Test Counseling Points
● Most accurate result comes one week after the expected missed period
● Try to test urine sample immediately after collection
● Unless the directions say otherwise, test with first morning urine (highest
concentration)
Pregnancy Test Counseling Points
● Most accurate result comes one week after the expected missed period
● Try to test urine sample immediately after collection
● Unless the directions say otherwise, test with first morning urine (highest
concentration)
Female Fertility Tests
● Options for determining optimal timing of intercourse to promote or
discourage pregnancy
○ Tests predict ovulation/fertile period
○ Not considered a reliable means of birth control
● Basal thermometer
● Urine tests
Basal Thermometer:● Basal body temperature = BBT
○ Normal = 96.00 - 97.50* F
○ 24-48 hours after ovulation = rises to closer to 98.60*
Basal Thermometer-Instructions
○ Take temperature each morning (orally, rectally, or vaginally)
○ Plot temperatures in a graph
○ When temperatures rise → fertile time!
Basal Thermometer- What type of thermometer?
Use a basal thermometer (0.1 vs. 0.2 increments)
○ Interpreting may be difficult for some individuals
○ Digital basal thermometers are available
Urinary Hormone Test - LH Test (review)
• Designed to predict ovulation to assist in conception
• Identify surge in LH that occurs before ovulation by detecting
urinary excretion of LH
• Generally occurs 8-40 hours before ovulation
• Begin testing 2-4 days before estimated day of ovulation
• Not an effective contraception method
Male Fertility Test
● Sperm count is one factor of many that may impact male fertility
● OTC tests can measure sperm count
○ Positive test does not mean fertility! May be caused by other factors
Causes of low sperm count
○ Epididymitis
○ Hormone imbalance
○ Anabolic steroid use
SpermCheck Directions/Counseling
● Collect semen sample 2-7 days after last ejaculation
● Test within 3 hours of sample collection
● Collect semen sample via masturbation with
ejaculation into the provided cup
● Sample must sit for 20 minutes in order to thin in
consistency
● Withdraw semen sample using provided device and
add to the solution bottle
● Follow directions to mix
● Read results after 7 minutes
● Presence of line = positive test = normal levels
Fecal Occult Blood Test - Colorectal Cancer
● Colorectal cancer is the third leading cause of death in the U.S.
● Fecal occult blood tests screen for blood in stool
● These tests can be used as an ADJUNCT to other more invasive tests
● Two tests:
○ Pseudo-peroxidase based toilet test (FOBT)
○ Immunochemical based FOBT (iFOBT)
● Wide range of sensitivities and specificities in available tests
● Tests are more effective at detecting lower (vs. higher) GI abnormalities