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covid19_poctesting

COVID-19 point of care testing

Introduction

  • rapid point of care (POC) testing for Covid-19 is becoming more readily available in Australia, and as of Nov 1 2021, pending TGA approval home testing rapid antigen kits will become available
  • POC tests include:
    • rt-PCR - results usually take 20min to 1 hour depending on system and require expensive equipment to run them and each device is limited to 1-4 samples at a time
    • non-PCR
    • rapid antigen tests - results usually take around 15 minutes and a run similar to home pregnancy test kits

Rapid Antigen Tests (RATs)

  • generally have a swab in a self-contained tube for biohazard risk reduction
  • accuracy of RATs:
    • if symptomatic: sensitivity 72% specificity 99.4%
    • if asymptomatic (ie. “low risk Covid ED stream”): sensitivity 58% specificity 99.4%
  • PanBio Nasal
    • cost $AU7.50 per test
    • user adds agent fluid into tube
    • user takes swab then inserts into tube, swirling it to mix with fluid then breaks swab off and replaces tube cap
    • user then squeezes a few drops from tube onto a test device which will then display positive or negative within 15-20 minutes

Asymptomatic "low risk" Covid patients

  • sensitivity 58% specificity 99.4%
Prevalence in testing cohort Positive tests per 5000 Negative tests per 5000
% Number infected per 5000 Total True Pos False Pos Total True Neg False Neg
0.5% 25 39 15 25 4961 4950 10
1% 50 54 29 25 4946 4925 21
10% 500 313 291 22 4687 4478 209

Symptomatic suspected "High risk" Covid patients

  • sensitivity 72% specificity 99.4%
Prevalence in testing cohort Positive tests per 5000 Negative tests per 5000
% Number infected per 5000 Total True Pos False Pos Total True Neg False Neg
0.5% 25 43 19 25 4957 4950 6
1% 50 62 37 25 4938 4925 13
10% 500 393 371 22 4607 4477 130

Potential utility of RATs in ED

  • negative tests probably will not change Ed Mx or streaming
    • HOWEVER, a negative result may enable a lower probability Covid in the HR Covid stream to be re-allocated to LR stream
  • positive test in a low risk Covid could move that patient to High Risk status
  • positive test in a high risk Covid could move that patient to Covid zone status to be cohorted with Covid positive patients

Rapid rt-PCR tests

  • accuracy appears to be comparable to lab-based PCR testing
  • mainly used in EDs, ICUs, peripheral laboratories
  • generally not used in main pathology labs as POCT devices are resource intensive to manage in terms of; staffing, clinical oversight, logistics, friction costs, document control/QA, validation, implementation, and are expensive to operate.
GeneXpert Xpress (Cepheid) Qiagen QIAstat Roche Liat
cost of machine $AU $65,600 for platform with capacity to perform tests 2 samples at a time $96,600 for 4 samples at a time $50,000 for initial operational/analytical units + $37,000 for each additional add on analytical module (up to a maximum of 4) $22,000 per Liat
cost per test $AU $39.50 $100-$110 per test $64 per test
time to result excl. swab handling time 45min 60min 20min
max. concurrent tests 2-4 depending upon machine 4 1
tests available SARS-CoV-2 +/- Flu A, Flu B and RSV SARS-CoV-2 and 21 other viral and bacterial respiratory targets SARS-CoV-2 only
covid19_poctesting.txt · Last modified: 2021/10/02 03:36 by gary1

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