Performance of Nucleic Acid Amplification Tests for Detection of Severe Acute Respiratory Syndrome Coronavirus 2 in Prospectively Pooled Specimens

Details

• Alternative Title:
  Emerg Infect Dis
• Personal Author:
  Wang, Hannah ; Hogan, Catherine A. ; Miller, Jacob A. ; Sahoo, Malaya K. ; Huang, ChunHong ; Mfuh, Kenji O. ; Sibai, Mamdouh ; Zehnder, James ; Hickey, Brendan ; Sinnott-Armstrong, Nasa ; Pinsky, Benjamin A.
• Description:
  Pooled nucleic acid amplification tests for severe acute respiratory syndrome coronavirus 2 could increase availability of testing at decreased cost. However, the effect of dilution on analytical sensitivity through sample pooling has not been well characterized. We tested 1,648 prospectively pooled specimens by using 3 nucleic acid amplification tests for severe acute respiratory syndrome coronavirus 2: a laboratory-developed real-time reverse transcription PCR targeting the envelope gene, and 2 commercially available Panther System assays targeting open reading frame 1ab. Positive percent agreement (PPA) of pooled versus individual testing ranged from 71.7% to 82.6% for pools of 8 and from 82.9% to 100.0% for pools of 4. We developed and validated an independent stochastic simulation model to estimate effects of dilution on PPA and efficiency of a 2-stage pooled real-time reverse transcription PCR testing algorithm. PPA was dependent on the proportion of tests with positive results, cycle threshold distribution, and assay limit of detection.
• Subjects:
  Clinical Laboratory Techniques Coronavirus Infections/diagnosis COVID-19 Testing COVID-19/diagnosis False Negative Reactions Humans Molecular Diagnostic Techniques Nucleic Acid Amplification Techniques Prospective Studies SARS-CoV-2 Sensitivity And Specificity Specimen Handling Stochastic Processes

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• Source:
  Emerg Infect Dis. 27(1):92-103
• Pubmed ID:
  33183494
• Pubmed Central ID:
  PMC7774575
• Document Type:
  Journal Article
• Volume:
  27
• Issue:
  1
• Collection(s):
  Emerging Infectious Diseases
• Main Document Checksum:
  urn:sha256:0df307f884c95308c3018393f20152259afd3bdaff608e0b85992f927800bc27
• Download URL:
  https://stacks.cdc.gov/view/cdc/99995/cdc_99995_DS1.pdf
• File Type:
  [PDF - 3.73 MB ]