Public Health England assessed COVID-19 serological assay laboratory tests

Jun 2020

Public Health England has carried out a number of rapid evaluations of commercial serological tests for their suitability for detecting the production of COVID-19 antibodies. Abbott SARS-CoV-2 IgG assay and the Roche Elecsys Anti-SARS-CoV-2 serology assay were evaluated by Public Health England.

Public Health England came to the following conclusion regarding Abbott SARS-CoV-2 IgG for the detection of anti-SARS-CoV-2 antibodies:

Abbott SARS-CoV-2 is a highly specific test with a specificity of 99.73%. This is in line with the manufacturer's reported specificity of 99.63%
Overall, the sensitivity of the assay was found to be 92.71% for all positive samples tested. The sensitivity of the assay for the samples collected < 14 days after the onset of the symptom was 85.71%, which was consistent with the sensitivity of the manufacturer to 86.36% early collected samples. However, for samples collected 14 days after the onset of the symptom, Public Health England found that the sensitivity of the assay was 93.90% lower than the sensitivity of 100% reported by the manufacturer. The sensitivity of the assay at ≥ 21 days after the onset of the symptom is 93.40% and 87.5% at > 40 days after the onset of the symptom

Public Health England came to the following conclusion regarding Roche Elecsys Anti-SARS-CoV-2 serology assay for the detection of anti-SARS-CoV-2 antibodies:

the Elecsys Anti-SARS-CoV-2 assay is a very highly specific assay with a 100% specificity
The sensitivity of the test ranged over time, rising from 75% for a period of ≤ 20 days to 100% sensitivity > 40 days after the onset of the symptom. The assay 's sensitivity from the onset of 21 days after the symptom is 87.7%. The assay 's overall sensitivity is 83.87%
That is in line with the sensitivity data supplied by the manufacturer. The cut-off used by
the manufacturer was found to be on the high side and could be reduced with very little
loss in specificity

See the full details here.

Subscribe to our newsletter delivered every second week not to miss important reimbursement information.

The latest related news

MTP Council updated recommendations on gene expression analysis for decision-making on the adjuvant breast cancer treatment

Mar 2022

In late January 2022, Swedish Medical Technologies Product (MTP) Council issued an updated version of recommendations regarding gene expression analysis for decision-making on the adjuvant breast cancer treatment, initially published in November 2021. The recommendation to the regions remains the same. The changes were only concerned with the clarification of some facts.

NHS Insights Prioritisation Programme in England

Mar 2022

The NHS Insights Prioritisation Programme (NIPP) is commissioned by the NHS Accelerated Access Collaborative (AAC) and the National Institute for Health Research (NIHR). It is designed to accelerate the evaluation and implementation of innovation that supports post-pandemic ways of working, builds service resilience, and delivers benefits to patients. Fourteen projects have been funded and have now commenced activity that will be ongoing until March 2023.

2022 RIHN and Supplementary list for IVD tests published in France

Mar 2022

On February 22, 2022, a repository of innovative acts outside the nomenclature of biology and anatomopathology (RIHN) and a Supplementary list of IVD tests were published. Minor changes were introduced in the 2022 RIHN list.

Draft Order amending the Common Package of Benefits of the Spanish National Health System

Mar 2022

On February 21, 2022, it was announced by the Ministry of Health that the public consultation regarding the Draft Order amending the Common Package of Benefits of the National Health System (SNS) was open. The amendments and clarifications are related to the fields of in-vitro diagnostics, ENT, pulmonary and airways, e-health, neurology, dental care, radiology, and enteral nutrition.

New procedure and diagnostic codes added to the private reimbursement schedule in England

Mar 2022

In February 2021, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclature for private payers in England, published Bulletins 0182 and 0079 with changes to be implemented no later than April 10, 2022. Three new procedure codes concerned robotic surgery in orthopaedic area, spinal procedures, and ophthalmology, and five new diagnostic codes were introduced.