DIAGNOSIS WORKSHEET

Citation:
CHAIMAYO, Chutikarn, et al. Rapid SARS-CoV-2 antigen detection assay in
comparison with real-time RT-PCR assay for laboratory diagnosis of COVID-19 in
Thailand. Virology journal, 2020, 17.1: 1-7.

Are the results of this diagnostic study valid?

Was there an independent, blind
comparison with a reference (“gold”)
standard of diagnosis?
Was the diagnostic test evaluated in an
appropriate spectrum of patients (like
those in whom it would be used in
practice)?
Was the reference standard applied
regardless of the diagnostic test result?
Was the test (or cluster of tests) validated
in a second, independent group of
patients?
Yes, all patient in this study were tested
with RDT and RT-PCR
Yes, specimens were collected from 454
suspected COVID-19 including pre-operative
patients at Siriraj Hospital.
Yes, all patients received both the
diagnostic test and the reference standard
Yes, this test validated in several other
study

Are the valid results of this diagnostic study important?

SAMPLE CALCULATIONS
Target disorder
RT-PCR
Present Absent Totals
Positive 59 5 64
Diagnostic (< 65 mmol/L) a b a+b
test result
(RDT) Negative 1 389 390
( 65 mmol/L) c d c+d
60 394 454
Totals a+c b+d a+b+c+d

Sensitivity = a/(a+c) = 59/60 = 98.3%

Specificity = d/(b+d) = 389/394 = 98.7%
Likelihood ratio for a positive test result = LR+ = sens/(1-spec) = 0.983/(1-0,987) =
75.6
Likelihood ratio for a negative test result = LR - = (1-sens)/spec = (1-0.983)/0.987) =
0.017
Positive Predictive Value = a/(a+b) = 59/64 = 92.2%
Negative Predictive Value = d/(c+d) = 389/390 = 99.7%
Pre-test probability (prevalence) = (a+c)/(a+b+c+d) = 60/454 = 13.21%
Pre-test odds = prevalence/(1-prevalence) = 13.21/(86.79) = 0.15
Post-test odds = pre-test odds  LR = 0,15x(75,6/0.017) = 667

Post-test probability = post-test odds/(post-test odds +1)= 667/668= 99.8%

Can you apply this valid, important evidence about a diagnostic test in caring for
your patient?

Is the diagnostic test available, affordable, Yes, the test is available, affordable,
accurate, and precise in your setting? accurate and precise
Can you generate a clinically sensible - Yes, this study similar in my own.
estimate of your patient’s pre-test probability
(from personal experience, prevalence Yes, is it. The possibilities or
statistics, practice databases, or primary probabilities in this study can be
studies)? changed depends on prevalency in one
 Are the study patients similar to your territory.
own?
 Is it unlikely that the disease possibilities
or probabilities have changed since the
evidence was gathered?
Will the resulting post-test probabilities - Yes, it can fast and efficient
affect your management and help your for screening and diagnostic
patient?
 Could it move you across a test-
treatment threshold?
 Would your patient be a willing partner
in carrying it out?
Would the consequences of the test help Yes
your patient?

Additional notes: