Lecture 21: Home testing & Monitoring Devices Flashcards

(80 cards)

1
Q

Home diagnostic market is motivated by:

A

○ 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

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2
Q

Regulation

A

● FDA requires that tests are as accurate as professional use
equivalent
● CAVEAT: Test must be used correctly

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3
Q

General Considerations with OTC Testing

A
● 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
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4
Q

General Counseling Points

A

● 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

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5
Q

Sensitivity

A

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

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6
Q

Specificity

A

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

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7
Q

Sensitivity and specificity are

A

they are inversely related

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8
Q

Sensitivity and specificity are valued differently for different tests

A

○ 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?

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9
Q

How sensitive is the test

A

How many actually-pregnant women does it correctly identify as pregnant?

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10
Q

How specific is the test?

A

How many not-pregnant women does it correctly confirm as not-pregnant?

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11
Q

What is the false-negative rate?

A

How many women who were pregnant were told they weren’t

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12
Q

What is the false-negative rate?

A

How many women who weren’t actually pregnant

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13
Q

Pregnancy Test (review)

A

● 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

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14
Q

Pregnancy Test Counseling Points

A

● 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)

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15
Q

Pregnancy Test Counseling Points

A

● 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)

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16
Q

Female Fertility Tests

A

● 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

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17
Q

Basal Thermometer:● Basal body temperature = BBT

A

○ Normal = 96.00 - 97.50* F

○ 24-48 hours after ovulation = rises to closer to 98.60*

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18
Q

Basal Thermometer-Instructions

A

○ Take temperature each morning (orally, rectally, or vaginally)
○ Plot temperatures in a graph
○ When temperatures rise → fertile time!

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19
Q

Basal Thermometer- What type of thermometer?

A

Use a basal thermometer (0.1 vs. 0.2 increments)
○ Interpreting may be difficult for some individuals
○ Digital basal thermometers are available

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20
Q

Urinary Hormone Test - LH Test (review)

A

• 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

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21
Q

Male Fertility Test

A

● 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

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22
Q

Causes of low sperm count

A

○ Epididymitis
○ Hormone imbalance
○ Anabolic steroid use

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23
Q

SpermCheck Directions/Counseling

A

● 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

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24
Q

Fecal Occult Blood Test - Colorectal Cancer

A

● 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

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25
FOBT
● Utilizes a pseudo-peroxidase reaction using a chromagen that turns blue-green when oxidized by hemoglobin ● Blue green = positive test ● Test relies on fecal blood from stool will be left in the toilet bowl after a bowel movement
26
iFOBT
● Uses antibodies to detect human hemoglobin protein in stool ● Test reacts to part of hemoglobin protein found in red blood cells ● Stool is sampled from toilet tissue after a bowel movement
27
False Positives
● Other GI conditions that cause bleeding: ○ Ulcers, Crohn’s disease, colitis, diverticulitis, anal fissures, hemorrhoids ● Menstruation → wait to take the test ● Certain medications: ASA, NSAIDs, steroids, rectally administered ○ Ideally meds should be avoided for 2-3 days before ● Toilet bowl cleaners?
28
FOBT Patient Counseling
● Increase dietary fiber intake for several days before testing ○ Roughage may stimulate bleeding from lesions ● Perform the test on 3 consecutive bowel movements ○ Cancerous lesions may bleed intermittently ● Some prescription medications may cause bleeding; consult with a healthcare provider before discontinuing
29
Toilet Test Procedure
● Remove toilet tank cleansers or deodorizers, and flush toilet twice before testing. ● Keep test pads in original foil pouch until time of testing. ● Before testing, use one test pad to perform a water quality check. Hold the pad by its corners and drop it into the toilet bowl. If any trace of blue appears in the cross-shaped area when the pad is placed in the toilet water, use another toilet to complete the testing. Perform this water quality check on the second toilet as well. ● Immediately after a bowel movement, place a pad in the toilet bowl, printed side up. After 2 minutes, check for the appearance of a blue cross on the test pad (positive result). ● If color changes differ from the blue cross, discard the pad and repeat the test after the next bowel movement. ● Repeat the test on the next two bowel movements
30
Stool Application Product
● After a bowel movement, wipe the anal area as normal, and retain a small amount of stool on toilet paper. ● Unscrew cap/wand from buffer tube. ● Collect a small sample of stool onto the grooves of the buffer tube cap/wand. ● Return cap to tube and screw tightly. Shake tube for 3 seconds. Unscrew smaller clear cap at top of tube. ● Apply 3 drops from tube to sample well. ● Read results after 5 minutes. There should be a red line at “C,” which indicates the test is working. A positive test will also have a line at “T.” Do not read results if 10 minutes has elapsed
31
FOBT as a Screening Test | ● Screening Recommendations
○ Start screening for colon cancer at 50 years old and screen every 5-10 years (high risk start at age 40-45) ○ USPSTF recommends FOBT, sigmoidoscopy, or colonoscopy ○ American College of Gastroenterology recommends colonoscopy (more sensitive) ○ American Cancer society recommends FOBT annually, colonoscopy every 10 years
32
FOBT as a Screening Test | Testing is a SCREENING method -
does not diagnose a specific disease ○ Test indicates that there is any bleeding in the GI tract ○ If positive → visit healthcare provider for full workup
33
FOBT would be considered a test with low ________ because of the possible high rate of false positives from conditions like Crohns or ulcers. A. Sensitivity B. Specificity
A. Sensitivity
34
Cholesterol Test
Used for more frequent cholesterol screenings ○ Hypercholesterolemia is a chronic condition ○ Monitoring can help promote adherence to lifestyle and medication regimens
35
Cholesterol Test Tests vary:
Some allow measurement at home ○ Others allow collection at home with a measurement by a lab ○ Efficacy rates vary…
36
Cholesterol Test Examples:
CholesTrak ○ First Track ○ Cardiochek (also a professional version of this)
37
Cholesterol Test Pearls
``` ● Good finger stick technique required ○ Hanging drops of blood required ○ Collection must be fairly quick ○ Avoid “milking” the finger ● Avoid vitamin C >500mg before the test ● High/abnormal test results should follow up with provider ```
38
OTC Cholesterol tests vary in what they measure
→ LDL, HDL, triglycerides
39
Urinary Tract Infection Tests
``` ● Lead to 8-10 million HCP visits annually ● Symptoms: ○ Painful urination ○ Urinary urgency ○ Blood in urine ○ Lower abdominal pain/discomfort ```
40
Urinary Tract Infection Tests Reasons for testing
Reasons for testing: ○ Early detection ○ Confirmation of cure
41
UTI Test
``` ● Available as Azo Strips, store brands ● Detects nitrate (reduction product of gram negative bacteria) and leukocyte esterase (enzyme specific to WBCs) ● Sensitivity of 68-90% ```
42
UTI Test: False negative tests:
• Vegetarian diet ○ Tetracycline ○ Vitamin C (within 10 hours)
43
Human Immunodeficiency Virus (HIV) Test Risk Factors
○ Those who share needles or syringes ○ Sexual intercourse with someone infected with HIV ○ Blood transfusion between 1978 and 1985 ○ Born to a mother infected with HIV
44
Human Immunodeficiency Virus (HIV) Test Various tests available
○ Blood sample + mail to lab | ○ Saliva test + result at home (OraQuick® )
45
Human Immunodeficiency Virus (HIV) Test detects antibodies
○ May take between 3 weeks to 6 months to appear after exposure
46
HIV Test - Saliva
● Remove the test tube from packaging, pop it open, and insert it into the holder. Hold the test tube upright to avoid spilling the liquid that is inside. ● Remove the test stick from packaging. Do not touch the test pad. ● Swipe the test pad along upper and lower gums. Swipe each gum only once. ● Insert the test stick into the test tube with the test window facing forward. Start timing. ● Read the test result in the test window at 20 minutes. After 40 minutes, the results may be invalid. ● The test kit provides guidelines for how to read the results and what the results mean. One line at C is negative. A line at C and T is positive. ● Note that counseling on performing the test is available 24 hours a day from the company
47
HIV Test - Blood
● Using alcohol, clean the fingertip chosen for puncture. Allow alcohol to dry. ● Prick the cleaned fingertip using the lancet provided, and place a few drops of blood on the blood specimen card. Fill the circle on the card completely to ensure a readable test. Examine the back of the card to ensure that the blood soaked through. If it did not, place more blood on the front of the card. If a second fingerstick is needed, use the second lancet provided in the kit. ● Allow the card to air dry for 30 minutes; place the sample in the specimen return pouch, and seal the pouch in the prepaid and addressed shipping package. Be sure that the processing laboratory receives the specimen within 10 days of sampling. ● To obtain the results, call the manufacturer’s toll-free number 3–7 business days after mailing the specimen, depending on which test kit was used. ● Note that counseling is available 24 hours a day, for both negative and positive results, and counseling is included in the cost of the testing unit.
48
Hepatitis C Test
● Hepatitis C induces liver damage by causing hepatic cell necrosis and inflammation → fibrosis, cirrhosis, carcinoma ● Most common blood borne pathogen in the U.S.
49
Hepatitis C Test Risk Factors
○ Use of injectable drugs ○ Receipt of clotting factors before 1987 ○ Blood transfusion, long term hemodialysis or organ transplant prior to 1992 ○ Sexual intercourse with multiple partners ○ Born to mother infected with HCV
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Hepatitis C Test May go undetected for years
○ Screening recommended for all adults born between 1945 and 1965
51
Hepatitis C Test: Test for antibodies
● Tests for ANTIBODIES ○ May take 6 months for HCV antibodies to develop after exposure ● Positive tests should be referred to HCP
52
Hepatitis C Check ® Directions
● Register the PIN (personal identification number) with the manufacturer by calling the provided tollfree telephone number and following the automated directions. ● Remain seated during the testing process to prevent falling if dizziness occurs. ● Before starting the test, wash your hands thoroughly with soap and warm water, and then dry them. ● Date the blood sample card. ● Lance the side of one of your middle fingers. ● Apply a sufficient number of blood drops until both the front and back of the circular area on the testing card are saturated. ● Allow the sample to dry at least 30 minutes before sealing it in the pouch and mailing it. ● Within 4–10 business days after mailing the sample, call the toll-free number provided, using the PIN to access the test results. Test results are available for up to 1 year. ● Note that counseling is included in the cost of the testing unit and is available 24 hours a day, for both negative and positive results
53
Drug Tests
``` ● Various tests on the market ○ Most are send away ○ Some have a home option first, then send away confirmation ○ May test for 1 drug or many ● Different collection techniques ○ Urine ○ Hair ● Tests are only qualitative- yes/no (not amount or route of administration) ● False positives: ○ Decongestants, DXM, antidiarrheals, cough medicine with codeine ```
54
Blood Pressure Monitors
● 32% of Americans over 20 have hypertension ● Home blood pressure monitoring can be used in screening and monitoring ○ “White coat syndrome” ○ Regular monitoring ○ Promotes medication, lifestyle adherence ● Monitors built for arms, wrist, finger ○ Finger are generally considered inaccurate ○ Wrist may be more accurate in individuals who are obese
55
Blood Pressure Monitor Counseling Points
● Choose a correct cuff size ○ May impact reading by 20-30mmHg ○ Use a wrist cuff if large enough cuff is not available ● Wrist cuffs must be held at heart level ○ Rest arm on a table/pillow to get to correct height
56
Nucleic Acid Amplification | Tests (NAAT) Mechanism
Detect RNA Polymerase chain reaction (PCR) test is a type of NAAT
57
Nucleic Acid Amplification | Tests (NAAT) Test Process
Sent to labs
58
Nucleic Acid Amplification | Tests (NAAT) Accuracy
Highly sensitive and specific
59
Nucleic Acid Amplification | Tests (NAAT) Time it takes
1-7 days
60
Antigen Tests Mechanism
Detect pieces of protein from the virus → high level of virus in sample is needed
61
Antigen Tests: Test process
Sample applied to test strip or cartridge
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Antigen Tests: Accuracy
Moderate to high sensitivity, | high specificity
63
Antigen Tests: Time it takes
10-15 minutes
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Sensitivity & Specificity of COVID Tests
● NAAT tests have high sensitivity ○ Important to minimize false negatives to limit the spread of COVID ● Despite high specificity of antigen tests, false positives are possible ○ Especially in communities where the prevalence of infection is low ○ In general, the lower the prevalence of infection in the community, the higher the proportion of false positive test results
65
Home Collection COVID Tests Directions:
○ Register kit, collect sample using nasal swab, ship sample to lab, access results online 1-2 days after sample is received
66
Home Collection COVID Tests: Advantages
○ Most sensitive | ○ Usually does not need to be repeated to confirm results
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Home Collection COVID Tests: Disadvantages
○ Expensive → ~$125 ○ Longer turnaround time ○ A positive NAAT diagnostic test should not be repeated within 90 days, since people may continue to have detectable RNA after risk of transmission has passed
68
At-Home COVID Tests: Directions
``` ● Antigen tests ● Directions: ○ Swab nose, perform test, analyze results in 15 minutes ● Age 2 and up with or without symptoms ○ Test twice within 3 days ```
69
At-Home COVID Tests: Advantages
○ Not as expensive → ~$25 ○ Short turnaround time ○ Comparable performance to NAAT tests in symptomatic people
70
At-Home COVID Tests: Disadvantages
Less sensitive especially among asymptomatic people | ○ May need confirmatory testing
71
Which COVID Test is Better?
● NAAT tests are considered the gold standard ● PCR tests are usually required for travel ● Antigen tests are preferred for surveillance testing ○ Sensitivity may not be as important as frequency of testing
72
COVID test: ● General peace of mind
○ Antigen or NAAT test 3-5 days after potential exposure
73
Symptomatic
Antigen and NAAT have comparable sensitivity when viral load in the specimen is high and the person is most likely to be contagious
74
Other OTC Available Tests
``` ● Alcohol screening tests ● Visiderm (mole changes) ● Breast self-examination aid ● Vaginal pH test ● Tobacco/Nicotine exposure test ● Paternity test ● Menopause test ● Strep A test ● Home electrocardiogram monitor ```
75
Closing the Loop
● Offer counseling to patients who purchase these products ● Be available to answer questions ● Familiarize yourself with local resources ○ Planned Parenthood ○ Free/low-cost clinics ○ Urgent care facilities
76
Beyond OTC….Laboratory Testing
● Centers for Medicare & Medicaid Services (CMS) regulates human laboratory testing through the Clinical Laboratory Improvement Amendments (CLIA) ● Objective = ensure qualified laboratory testing through lab certification ● If lab testing is being provided then the a lab must be CLIA certified!
77
CLIA Waivers: Some tests are considered “CLIA-waived”
○ The FDA decides which tests are waived ○ Must meet criteria of “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result” ○ MUST observe and follow package directions from the manufacturer (i.e. individuals must be familiar with and trained in administering these tests) ○ These tests can be completed in a non-lab setting (pharmacy, doctor’s office, clinic)
78
CLIA Waivers Examples
○ A1C test ○ CardioCheck (lipid/glucose) ○ Strep test ○ Influenza test
79
CLIA Waiver characteristics
● In 39 states, a pharmacist may administer CLIA-waived tests by obtaining a waiver certificate for their pharmacy ● In NYS, a pharmacist may NOT operate a CLIA waived lab ○ However, they can be employed by that lab to administer tests under a qualified director - but they are not doing this as a pharmacist, they are doing it as a trained employee
80
What about COVID Testing?
● April 8, 2020: Health and Human Services (federal agency) authorized pharmacists to order and administer COVID-19 tests authorized by the FDA ● April 25, 2020: NYS Executive order allowing pharmacists to order/administer COVID-19 tests