CE-IVD SENSITIVE DETECTION OF THE SARS-COV-2 IgG ANTIBODIES
GSP®/DELFIA® Anti-SARS-CoV-2 IgG Kit
The 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.
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® 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 (DBS) SAMPLE
Sampling from finger prick
Small volume of blood
Shippable in envelope
Stable at room temperature
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
DELFIA® TECHNOLOGY
Based on Time-Resolved Fluorescence
Sensitive
Robust
INSTRUMENT PLATFORMS
| Platform | 
GSP® Platform |
|---|---|
| Antibody detected | IgG |
| Assay concept | Solid phase fluoroimmunoassay based on sandwich technique DELFIA (Time-Resolved Fluorescence) |
| Antigen used | S1 domain |
| Sample type | Dried blood spot samples |
| Kit size | 12x 96 wells |
| Assay processing | Fully automated, traceable |
| Assay run time | ~2 hours per plate/96 wells |
| Capacity | ~40 plates (~3,600 samples) a day with continuous loading |
| Results | Qualitative (pos/neg), numerical ratio visible |
| Sensitivity | 96%* |
| Specificity | 100%* |
*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 is shipped at ambient temperatures.