CE-IVD SENSITIVE DETECTION OF THE SARS-COV-2 IgG ANTIBODIES

PerkinElmer® GSP®/DELFIA® Anti-SARS-CoV-2 IgG Kit

The PerkinElmer® GSP®/DELFIA® Anti-SARS-CoV-2 IgG kit has been designed to run dried blood samples on the fully automated and high throughput screening GSP® instrument, as well as serum/plasma on a manual time-resolved fluorescence reader, e.g. VICTOR2™ D instrument.

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The kit is intended for the qualitative detection of human antibodies of the immunoglobulin class IgG against SARS-CoV-2 in human blood specimens dried on filter paper and in human serum as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

Dried Blood Spot is a sample type where only few drops of blood are collected e.g by fingerprick and dried directly on a filter paper card. This minimally invasive blood sample collection method is more acceptable to patients than venous puncture that is needed for typical assays measuring the analyte from serum or plasma, therefore, it has the potential for sampling in various settings. The sample card can be easily shipped via regular mail and overcomes logistical barriers for sample collection as no cold transport or sample processing is needed.

Since large numbers of samples can be obtained in short time periods, several samples can be analyzed from one sample card and while keeping cost to a minimum, it offers an ideal method for population-based testing. Dried blood spot sample is a proven population-based screening method that has been used successfully in newborn screening for decades. A recent study of University of Milan showed an good concordance between results obtained with DBS eluates and serum samples (Amendola et al. 2020).

GSP Platform

GSP® Instrument System Features

The GSP® system offers outstanding accuracy and reliability, coupled with high efficiency.

  • Dried Blood Sample: No need for venous blood draw, easy to transport

  • High Throughput:  Run up to 200 samples an hour

  • Fully Automated:  Reduced hands-on stages and reduced risk of error

dried blood spot samples

DRIED BLOOD SPOT (DBS) SAMPLE

Sampling from finger prick


Small volume of blood


Shippable in envelope


Stable at room temperature

PE GSP Instrument

GSP® INSTRUMENT

Fully automated, designed for DBS samples


Full traceability with barcodes


~3,600 samples/day


~500 placements globally in newborn screening

ONE KIT FOR BOTH NEEDS

AUTOMATED
GSP® system from DBS samples


MANUAL
VICTOR2™ D instrument/manual TRF from serum/plasma samples

DELFIA Sars-CoV-2

DELFIA® TECHNOLOGY

Based on Time-Resolved Fluorescence


Sensitive


Robust

INSTRUMENT PLATFORMS

Platform GSP intrument

GSP® Platform

Victor 2D instrument

VICTOR2™ D Flourometer or TRF Reader

Antibody detected IgG IgG
Assay concept Solid phase fluoroimmunoassay based on sandwich technique DELFIA (Time-Resolved Fluorescence) Solid phase fluoroimmunoassay based on sandwich technique DELFIA (Time-Resolved Fluorescence)
Antigen used S1 domain S1 domain
Sample type Dried blood spot samples Serum/plasma samples
Kit size 12x 96 wells 12x 96 wells
Assay processing Fully automated, traceable Manual
Assay run time ~2 hours per plate/96 wells ~2 hours per plate/96 wells
Capacity ~40 plates (~3,600 samples) a day with continuous loading Dependent on operator
Results Qualitative (pos/neg), numerical ratio visible Qualitative (pos/neg), numerical ratio visible Win10 PC & VICTOR 2D workstation needed
Sensitivity 96%* 96.2%*
Specificity 100%* 98.7%*

*Clinical sensitivity using the recommended ratio cut-off of 2 for the DELFIA® procedure with 95% confidence intervals. GSP®/DELFIA® Anti-SARS-CoV-2 IgG kit was tested in two clinical laboratories in Finland using the DELFIA® procedure with samples 21 days or more from symptoms onset.

KIT CONTENTS

  • Antigen coated plates, 12 plates
  • Assay buffer x 3 bottles
  • Eu labeled Anti-human IgG tracer, 3 vials
  • Liquid calibrator, 1 vial
  • Liquid controls, 2 vials
  • Barcode labels for the plate, 12 pcs

CITATIONS

Amendola A, Bianchi S, Gori M, Barcellini L, Colzani D, Canuti M, Giacomet V, Fabiano V, Folgori L, Zuccotti GV, Tanzi E.  (2020 Nov 10) Dried Blood Spot as an Alternative to Plasma/Serum for SARSCoV-2 IgG Detection, an Opportunity to Be Sized to Facilitate COVID-19 Surveillance Among Schoolchildren. Pediatr Infect Dis J.

APPLICATION NOTE

Monitoring Immune Response Against SARS-CoV-2 using Dried Blood Spot

The kit will be shippable at ambient temperatures.

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Products may not be licensed in accordance with the laws in all countries, such as the United States and Canada.  Please check with your local representative for availability.