Point of Care Testing Overview
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Questions and Answers

What type of testing is conducted at the time and place of patient care?

Point of care testing

What governmental agency regulates facilities that conduct laboratory testing, including point-of-care testing, on human specimens?

CMS (Centers for Medicare & Medicaid Services)

Waived tests use only ______ specimens that require no manipulation.

unprocessed

What type of specimen is commonly used for testing for GAS, COVID-19, and Influenza A?

<p>Nasal secretion</p> Signup and view all the answers

What is the only CLIA-waived POCT for oral mucosal?

<p>HIV-1 and 2</p> Signup and view all the answers

Which type of POCT for infectious diseases will detect active infection?

<p>Molecular test (A)</p> Signup and view all the answers

A positive antigen test always means an active infection.

<p>False (B)</p> Signup and view all the answers

Which of these terms describes the ability of a test to correctly identify those with the disease?

<p>Sensitivity (A)</p> Signup and view all the answers

What does the positive predictive value of a test represent?

<p>The proportion of true positives relative to all positive results.</p> Signup and view all the answers

What does the term POCT stand for?

<p>Point of care testing</p> Signup and view all the answers

What is the recommended testing frequency for Hepatitis C in adults?

<p>Routine testing for all adults and risk-based testing for those over 18 years old.</p> Signup and view all the answers

What is the recommended testing frequency for HIV in individuals aged 13-64?

<p>At least once and high-risk individuals annually</p> Signup and view all the answers

What is a key consideration for influenza A/B testing, with regards to the timing of the test?

<p>Prompt initiation of therapy</p> Signup and view all the answers

What condition does Streptococcus pyogenes cause?

<p>Group A streptococcus</p> Signup and view all the answers

What is the Modified Centor Score used for?

<p>Assessing the likelihood of Group A streptococcus infection.</p> Signup and view all the answers

What are some limitations of POCT?

<p>Overtesting and the ability to use results for therapeutic decisions must fall within the scope of practice.</p> Signup and view all the answers

What is pharmacogenetics?

<p>The intersection of pharmacology and genetics, studying how inherited variations in genes affect drug responses.</p> Signup and view all the answers

What is personalized medicine?

<p>Tailoring medical treatment to the specific characteristics of each patient, including their genetic makeup.</p> Signup and view all the answers

What is genomics?

<p>The study of the entire set of genetic instructions found in a cell (DNA).</p> Signup and view all the answers

Define pharmacogenomics.

<p>The branch of pharmacology that uses DNA and amino acid sequence data to inform drug development and testing.</p> Signup and view all the answers

Define pharmacogenetics (PGt).

<p>The study or clinical testing of genetic variation to assist with individual patient drug response differentiation.</p> Signup and view all the answers

Many patients are poor metabolizers of cytochromes in the liver that metabolize commonly prescribed medications.

<p>True (A)</p> Signup and view all the answers

An ultrarapid metabolizer may require 500mg of a drug, while a poor metabolizer may require how much of the same drug?

<p>10mg</p> Signup and view all the answers

What are single nucleotide polymorphisms (SNPs)?

<p>The most common type of genetic variation in humans, where a single nucleotide is replaced in the genetic sequence.</p> Signup and view all the answers

Different SNP expressions may modify a drug's therapeutic or adverse effect incidence.

<p>True (A)</p> Signup and view all the answers

Which of these benefits are associated with personalized medicine?

<p>All of the above (E)</p> Signup and view all the answers

Which of these are limitations of personalized medicine?

<p>All of the above (D)</p> Signup and view all the answers

Which of these are the most significant CYP enzymes involved in drug metabolism?

<p>All of the above (E)</p> Signup and view all the answers

What is the defining characteristic of poor metabolizers?

<p>They process drugs more slowly than expected, resulting in increased drug levels and the risk of side effects and toxicity.</p> Signup and view all the answers

What is the defining characteristic of ultra-rapid metabolizers?

<p>The drug is metabolized too rapidly, leading to subtherapeutic levels and the need for higher doses, while metabolites may also be toxic.</p> Signup and view all the answers

Which CYP enzyme is the most extensively studied polymorphic drug-metabolizing liver enzyme in humans?

<p>Cytochrome P450 2D6</p> Signup and view all the answers

What is the term for the genetic makeup of an organism?

<p>Genotype</p> Signup and view all the answers

On average, what is the rate of genetic variation between two individuals?

<p>0.1%</p> Signup and view all the answers

What is the most common cause of genetic variation and what is the average frequency of these variations?

<p>Single nucleotide polymorphisms (SNPs), occurring every 1000 bases on average.</p> Signup and view all the answers

Which of these are examples of SNPs and their associated diseases?

<p>Both A and B (A)</p> Signup and view all the answers

How can SNPs impact drug response?

<p>SNPs can change drug response!</p> Signup and view all the answers

In which type of genetic variation are cytochrome P450 enzymes commonly found?

<p>SNPs</p> Signup and view all the answers

What enzyme has a high degree of genetic polymorphisms that influence alcohol metabolism?

<p>Alcohol dehydrogenase (ADH1B in particular)</p> Signup and view all the answers

A variation in CYP2D6 can create a decreased alcohol metabolism in the case of the prodrug Tamoxifen.

<p>True (A)</p> Signup and view all the answers

Current medicine utilizes the same diagnosis and prescription for a patient group, which can lead to negative effects.

<p>True (A)</p> Signup and view all the answers

A ______ is defined as a variation in DNA sequence that is present in at least 1% of the population, also known as a genetic ______.

<p>polymorphism; mutation</p> Signup and view all the answers

When does single nucleotide polymorphism occur?

<p>It occurs when more than one nucleotide change, or an entire gene insertion/deletion, or extra copies of a gene.</p> Signup and view all the answers

What is an allele?

<p>It is the variant (and wild type (WT)), form of a gene at a particular chromosomal location.</p> Signup and view all the answers

What does it mean that humans are diploid?

<p>Humans have two copies of every chromosome, thus two copies of each gene—each nucleotide base in the gene can be considered an allele—one allele from the biological mother, and one allele from the biological father.</p> Signup and view all the answers

What does A pair with in base pairing?

<p>T</p> Signup and view all the answers

What does the nomenclature VKORCI1173C mean?

<p>VKORCI is the gene, 1173 indicates the position of the nucleotide on the gene, and C represents a specific nucleotide.</p> Signup and view all the answers

What is the number and letter combination in a genetic nomenclature that identifies the gene (ex: VKORC11173C>T, ABCB13435 C>T)?

<p>The gene is identified by VKORC1/ABCB1 in these examples.</p> Signup and view all the answers

In the nomenclature CYP2C19 *1, CYP2C19 *2, and CYP2C19 *3, what do the * and number following the gene indicate?

<p>They identify the allele, indicating variations in CYP2C19 function based on the allele.</p> Signup and view all the answers

Explain the difference in function between the CYP2C19 1* and CYP2C19 2* alleles.

<p>CYP2C19 *1 (wild type) represents normal enzyme activity, while *2 represents no enzyme activity.</p> Signup and view all the answers

What is the recommended nomenclature system for all SNPs?

<p>The rs naming system, recommended by the Human Genome Variation Society.</p> Signup and view all the answers

What are the possible genotype combinations for CYP2C19?

<p>CYP2C19 *1/*1 (normal), CYP2C19 *1/*2 (reduced), CYP2C19 *2/*2, CYP2C19 *2/*3, CYP2C19 *3/*3 (no activity)</p> Signup and view all the answers

What are two examples of drugs where utilization has been changed by pharmacogenomics?

<p>Warfarin and Clopidogrel</p> Signup and view all the answers

What is the association between CYP2C9 *5, *6, *8, and *11 alleles and warfarin dose requirement in African Americans?

<p>These alleles occur in African Americans from 1-6% and are associated with lower warfarin dose requirements.</p> Signup and view all the answers

What is a haplotype?

<p>A set of alleles adjacent on a chromosome that are inherited together from a single parent.</p> Signup and view all the answers

What was the key change made to the FDA's Warfarin label revision?

<p>Identifying risk factors for bleeding and certain genetic variations in CYP2C9 and VKORC1 in a patient may increase the need for more frequent INR monitoring and the use of lower warfarin doses.</p> Signup and view all the answers

What is the most important enzyme for the metabolism of Clopidogrel in the liver?

<p>CYP2C19</p> Signup and view all the answers

What is the effect of the CYP2C19 *17 allele on Clopidogrel metabolism?

<p>It results in hypermetabolism (ultra-rapid metabolizer status), and drugs inhibiting 2C19, such as omeprazole, may decrease the conversion to the active metabolite, suggesting potential interactions with certain PPIs such as pantoprazole, rabeprazole, and others.</p> Signup and view all the answers

Patients with reduced function of CYP2C19 have significantly _______ levels of the active metabolite of Clopidogrel?

<p>lower</p> Signup and view all the answers

What does the *1/*1 genotype represent?

<p>It always represents the wild type genotype.</p> Signup and view all the answers

What are the three categories of kidney injury?

<p>All of the above (D)</p> Signup and view all the answers

What is serum creatinine and how is it relevant to renal function?

<p>Serum creatinine is a marker for filtration rate. Creatine, an energy source for muscle, decomposes into creatinine, which is cleared by the kidneys.</p> Signup and view all the answers

You can have low creatinine due to low muscle mass, and conversely, a bodybuilder may have high serum creatinine.

<p>True (A)</p> Signup and view all the answers

Greater serum creatinine means lower renal function.

<p>True (A)</p> Signup and view all the answers

Lower serum creatinine means greater renal function.

<p>True (A)</p> Signup and view all the answers

What is the name of the equation used to estimate glomerular filtration rate (GFR)?

<p>Cockcroft-Gault Equation</p> Signup and view all the answers

Define BUN (blood urea nitrogen).

<p>BUN measures the concentration of nitrogen (as urea) in serum, reflecting renal function, hydration status, and protein tolerance.</p> Signup and view all the answers

What happens to BUN levels as renal function worsens?

<p>BUN levels go UP as renal function declines.</p> Signup and view all the answers

Increased BUN can be due to decreased urine flow rate through the tubules.

<p>True (A)</p> Signup and view all the answers

High BUN can mean postrenal injury.

<p>False (B)</p> Signup and view all the answers

When a suspected intrarenal injury is being investigated, what laboratory values are helpful to consider?

<p>The BUN to SCr ratio</p> Signup and view all the answers

What is the role of a pharmacist in managing renal function?

<p>Monitoring for adverse drug effects, adjusting doses of renally eliminated drugs, and assessing trends in renal function.</p> Signup and view all the answers

Certain drugs can cause discoloration of urine samples.

<p>True (A)</p> Signup and view all the answers

What are some examples of medications that can cause red or orange-ish discoloration of urine?

<p>All of the above (D)</p> Signup and view all the answers

What are some examples of medications that can cause blue or greenish discoloration of urine?

<p>All of the above (E)</p> Signup and view all the answers

What are some examples of medications that can cause black or brownish discoloration of urine?

<p>All of the above (E)</p> Signup and view all the answers

What are the three Cs of urinalysis?

<p>Cells, Casts, Crystals</p> Signup and view all the answers

What are the main components of urine sediment analysis?

<p>Cells, Casts, Crystals</p> Signup and view all the answers

What is the significance of leukocyte esterase and nitrite in urinalysis?

<p>They indicate a Urinary Tract Infection (UTI)</p> Signup and view all the answers

Elevated troponin levels can indicate what?

<p>Cell death</p> Signup and view all the answers

High BNP indicates excessive volume in the left ventricle, as cardiomyocytes release BNP when stressed.

<p>True (A)</p> Signup and view all the answers

What is another name for a left anterior descending branch coronary artery blockage?

<p>Widowmaker</p> Signup and view all the answers

What is the role of the AV node in the heart?

<p>The AV node has automaticity but usually needs a signal for it to reach the ventricles.</p> Signup and view all the answers

What is considered the pacemaker of the heart?

<p>SA node</p> Signup and view all the answers

What are lipoproteins?

<p>Lipoproteins are complexes of cholesterol, triglycerides, and phospholipids, allowing for water-soluble transport of lipids in the bloodstream.</p> Signup and view all the answers

What is the Friedwald equation?

<p>The Friedwald equation is a common formula used to estimate LDL cholesterol levels, an important indicator of heart disease risk, based on readily available laboratory values.</p> Signup and view all the answers

What are the total cholesterol ranges?

<p>All of the above (D)</p> Signup and view all the answers

What are the low HDL cholesterol ranges for men and women?

<p>Men: &lt;40 mg/dL, Women: &lt;50 mg/dL (C)</p> Signup and view all the answers

What does a BNP level of 500 mean for a patient?

<p>Heart failure is likely</p> Signup and view all the answers

A TEE (transesophageal echocardiogram) is an invasive echocardiogram procedure.

<p>True (A)</p> Signup and view all the answers

TEEs provide a better image than a TTE (transthoracic echocardiogram) and can definitively rule out certain heart conditions.

<p>False (B)</p> Signup and view all the answers

What is a key consideration when interpreting serum creatinine levels?

<p>Muscle mass</p> Signup and view all the answers

Flashcards

Point of Care (POCT) Testing

Testing conducted at the time and place of patient care, utilizing FDA-approved, CLIA-waived tests.

Centers for Medicare and Medicaid Services (CMS)

The agency that regulates lab testing on human specimens, including POCT, for health assessment, diagnosis, prevention, or disease treatment.

Unprocessed Specimens

Unprocessed specimens, often body fluids, used for CLIA-waived tests.

Nasal Secretion

Nasal secretion, often collected through a nasal swab, used for testing various infections.

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HIV-1 and 2 Testing (Oral)

The only CLIA-waived POCT for oral mucosal specimens.

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Molecular Tests

Molecular tests, often using nasal or throat swabs, are the only POCT for infectious diseases that detect active infection.

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Antigen Tests

Positive antigen tests do not necessarily indicate active infection.

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Sensitivity (SNOUTS)

The ability of a test to correctly identify those with the disease (sensitive to disease presence, high chance of true positives).

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Specificity (SPINS)

The ability of a test to correctly identify those without the disease (specific to disease absence, high chance of true negatives).

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Positive Predictive Value

The proportion of true positives relative to all positive results.

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Negative Predictive Value

The proportion of true negatives relative to all negative results.

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Hepatitis C POCT

A routine POCT for adults, typically involving an antibody test to detect Hepatitis C infection followed by confirmation with HCV RNA PCR if positive.

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HIV POCT

A POCT recommended for individuals aged 13-64 at least once, and high-risk individuals annually. Antibody tests may not show results immediately due to antibody development time.

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Influenza A/B POCT

A POCT beneficial during influenza season due to the need for prompt antiviral therapy, typically within 24-72 hours of symptoms. Antigen tests provide faster results but with lower sensitivity compared to molecular tests.

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Group A Streptococcus (GAS) POCT

A POCT used to diagnose Group A Streptococcus, a common bacterial pathogen causing infections like strep throat.

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Modified Centor Score

A scoring system used to assess the likelihood of Group A Streptococcus infection, whereby patients with a score greater than 2 warrant laboratory screening.

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POCT Limitations

These tests are not appropriate for all situations, and their accuracy may vary. The use of their results for therapeutic decisions is under the scope of the healthcare professional.

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Pharmacogenetics

The study of how an individual's genetic makeup affects their response to medications.

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Personalized Medicine

Tailoring medical treatment to individual patient characteristics, focusing on personalized prevention strategies and improved treatment outcomes.

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Genomics

The study of the complete set of genetic instructions in a cell.

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Pharmacogenomics (PGx)

The use of DNA and amino acid sequence data to inform and optimize drug development.

Signup and view all the flashcards

Pharmacogenetics (PGt)

The study or clinical testing of genetic variations to differentiate patient response to drugs.

Signup and view all the flashcards

Genetic Variations in Drug Metabolism

Variations in genes affecting metabolism, particularly cytochrome P450 enzymes, can lead to differences in drug effectiveness.

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Poor Metabolizers

Individuals with a slower-than-expected metabolism, often due to variations in genes affecting drug processing enzymes, potentially leading to higher levels of the drug in the bloodstream and increased risk of side effects.

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Ultra Rapid Metabolizers

Individuals with a faster-than-expected metabolism, often due to genetic variations, potentially resulting in a need for higher drug doses or the development of toxic metabolites.

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Cytochrome P450 2D6

A key liver enzyme responsible for metabolizing numerous medications, including analgesics, antidepressants, and antiemetics.

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Cytochrome P450 2D6

A key liver enzyme responsible for metabolizing numerous medications, including analgesics, antidepressants, and antiemetics.

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Study Notes

Point of Care Testing (POCT)

  • POCT is conducted at the patient's bedside, not suitable for all lab tests.
  • It's FDA approved and CLIA waived.

Centers for Medicare & Medicaid Services (CMS)

  • Regulates labs conducting human specimen testing (including POCT).

CLIA Waived Tests

  • Use unprocessed specimens, no manipulation required.

POCT for Infectious Diseases

  • Molecular tests detect active infection.
  • Antigen tests don't always indicate active infection.

POCT Sensitivity and Specificity

  • Sensitivity (SNOUTS): Good at ruling out, high confidence in negatives; may mislabel healthy patients.
  • Specificity (SPINS): Good at ruling in, high confidence in positives; may mislabel sick patients.

Predictive Values

  • Positive predictive value: True positives / all positive results (true or false).
  • Negative predictive value: True negatives / all negative results (true or false).

Hepatitis C (HCV) POCT

  • Routine testing for adults, risk-based testing over 18.
  • Confirmed with HCV RNA PCR test.

HIV POCT

  • Age 13-64 should be tested once (and high-risk annually).
  • Antibody tests may take weeks to months to become reactive.

Influenza A/B POCT

  • Seasonally variable.
  • Rapid antiviral therapy window.
  • Ideal testing 24-72 hours after symptom onset.
  • Antigen tests available in 15 minutes, but lower sensitivity.

Group A Streptococcus (GAS) POCT

  • Common bacterial pathogen.
  • Modified Centor Score for screening, lab testing for scores >2 in adults.

POCT Limitations

  • Overtesting; concerns about therapeutic decision-making.

Pharmacogenetics and Personalized Medicine

  • Pharmacogenetics: Interaction of pharmacology and genetics.
  • Personalized Medicine: Tailor treatments to individual characteristics.
  • Genomics: Study of an organism's complete set of genetic instructions.
  • Pharmacogenomics: Uses DNA and amino acid sequences for drug development and testing.
  • Pharmacogenetics: Clinical testing of genetic variation for drug responses.

Drug Metabolism Variations

  • Many patients are poor metabolizers of cytochrome enzymes.
  • Ultra-rapid metabolizers may need higher drug doses.

Single Nucleotide Polymorphisms (SNPs)

  • Common genetic variations in humans.
  • One nucleotide replaced in the sequence.
  • SNPs can alter drug responses (e.g., warfarin doses).

Importance of Drug Metabolizing Enzymes

  • CYP3A4, CYP2D6, CYP2C9 and CYP2C19 are important enzymes.

Genotype, Alleles, and Nomenclature

  • Genotype: Genetic makeup of an organism.
  • Allele: Variant of a gene.
  • Humans are diploid.
  • Allele nomenclature: VKORC11173C/T, identifies specific base pair changes like C and T changes.

Pharmacogenomic Implications on Drug Therapy

  • CYP2C9/VKORC1 mutations affect warfarin dosage.
  • CYP2C19 mutations affect clopidogrel metabolism.

Renal Function Assessment

  • Serum creatinine: Marker for kidney filtration rate.
  • Blood Urea Nitrogen (BUN): Concentration of nitrogen (as urea) in serum.
  • BUN/SCr ratio: Aids in identifying prerenal dysfunction (e.g., low perfusion to the kidneys).

Urinalysis/Lab Testing

  • Urine discoloration can be due to certain medications.
  • Leukocyte esterase and nitrite: Indicators of a UTI.
  • Casts, cells, and crystals in urinalysis indicate kidney and bladder conditions.

Other Important Considerations

  • BNP (Brain Natriuretic Peptide): Elevated levels can suggest left ventricle volume overload.
  • Troponin: Elevated levels indicate potential cell death (myocardial damage).
  • Echocardiograms: TTE (Transthoracic) and TEE (Transesophageal) are imaging techniques to assess heart conditions.
  • SA node: Pacemaker of the heart.
  • Lipids: Cholesterol, Triglycerides, and High Density Lipoproteins.

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Description

This quiz covers the fundamentals of Point of Care Testing (POCT), including its approval status, regulation by CMS, and the categorization of CLIA waived tests. You'll explore the sensitivity and specificity of POCT, its application in infectious diseases, and understand predictive values in the testing process.

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