CLIA Waived Tests Flashcards
What is CLIA?
Clinical Laboratory Improvement Amendments of 1988
What does CLIA require?
that labs run in clinics have appropriate controls, maintenance, etc to ensure lab results are accurate
What are CLIA waived tests (in general)? What do clinics still have to have if run CLIA waived tests?
- Low complexity tests were waived from CLIA
- Don’t have to have a paid lab tech to run these tests
- Do still have to have an annual CLIA certification of waiver
Full diff dx for presentation of very sore throat
- Strep throat
- Mono
- Pharyngitis
- Tonsillitis
- Tonsilar abscess
- Epiglottitis (very dangerous, never lay pt down)
- Oral stomatitis
- Viral URI with PND
HPI and PE for case with very sore throat
HPI: febrile, myalgias, dysphagia, HA, nausea with emesis
PE: Maculopapular erythematous exanthema (sandpaper rash), macular erythematous exanthema (small red spots on roof of mouth), lymphadenopathy, edematous tonsils, exudat
What test would be run for initial visit with pt presenting with very sore throat
rapid strep
What suspect if rapid strep and C&S strep are negative and patient RTC with persistent pharyngitis
mono
what population is mono most common in
adolescents, group homes/nursing homes, people who live in close proximity to each other
Pt presents with nasal congestion/PND, cough, runny nose, fever - what are two most likely
RSV
Influenza A/B
Extended differential for presentation with asal congestion/PND, cough, runny nose, fever
- Bronchiolitis
- Viral URI
- Asthma
- Allergic rhinitis
- PND
How collect sample for Rapid strep
- Good sample from posterior mouth
- swab the tonsils, the pillars and anywhere else see exudate (uvula for ex)
- Use two swabs at once (one for rapid strep and one for C&S in outside lab if needed)
what does C & S mean
culture and sensitivity
Is C&S CLIA Waived?
no
What does C&S do
Determines which strain is present
- strep pyogenes
- strep pneumonia
- strep viridans
What bacteria does the rapid strep test for?
Group A strep (GAS)
What does a positive test look like, a negative test? A test with an error?
- positive: two lines
- negative: one line
- Error: no lines
What does mono spot test look for?
protein in blood called heterophile antibody - produced by immune system in response to mono infection
Mono test timing
- highest number of antibodies 2-5 weeks after infection
- may be present for up to a year
- testing =< 10 days may give false negative
What population is mono test less accurate in?
<2 - due to decreased immune response
Mono spot test
- what is sampled
- type of test
- blood (can be serum, plasma, whole blood)
- flow through test
What type of test is RSV?
In vitro immunochromatographic assay
What population is RSV test best for?
<5 yo
RSV test
- how accurate
- how fast
- highly accurate
- 15 minutes
Where can get nasal sample from?
- nasal wash
- nasal swab
What type of test is Flu test?
In vitro immunochromatographic assay
Where get flu test sample from?
- Nasopharyngeal swab
- nasal swab
- nasal wash/aspirate
which sample for the flu test is most accurate?
nasal swab
What types of positive can flu test produce?
positive A
positive B
positive A&B
When to send strep test out for testing beyond rapid strep?
If rapid is negative but high suspicion for strep dx, send second swab for C&S
when to send mono test out for testing beyond mono spot test
If mono screen is negative but pt is symptomatic, send blood to lab for qualitative titer value and specific antibody testing
