Actim® ELISA SARS-CoV-2 IgG

Efficient mass testing of recent COVID-19 infection.

Overview

Efficient mass testing of recent COVID-19 infection

Actim® ELISA SARS-CoV-2 IgG offers laboratories a reliable and efficient method for mass testing of recent COVID-19 infection providing essential data for disease control measures, pandemic analysis and scientific research in just hours.

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing COVID-19 affects all countries. With more than 30 million people infected and a million dead by fall 2020, new tools are urgently needed for epidemiological research and development of vaccines and treatments for COVID-19.

The Actim ELISA SARS-CoV-2 IgG test detects recent COVID-19 infection from serum samples by measuring the specific immune reaction against the virus. The highly sensitive and specific test can be used, for example, to obtain critical information about the prevalence of COVID-19 at the population level, or to measure induced immune response during vaccine development.

Actim ELISA SARS-CoV-2 IgG | key facts

  • 96% sensitivity and 98% specificity against RT-PCR
  • Highly specific to SARS-CoV-2 in cross-reactivity tests of 16 viruses
  • Efficient mass testing for up to 80 samples at once
  • Gives quantitative results in less than 2 hours
  • Test kit contains all necessary reagents
  • Developed and produced in Finland

How it works

How Actim ELISA SARS-CoV-2 IgG works

Actim ELISA SARS-CoV-2 IgG detects a recent COVID-19 infection by recognizing specific IgG antibodies produced against the spike glycoprotein S1 (S1 protein) present on the surface of the SARS-CoV-2 virus. These specific antibodies can be detected as early as one week after the onset of infection and remain detectable for several months.

Actim ELISA SARS-CoV-2 IgG detects recent COVID-19 infection with outstanding specificity (98%) and sensitivity (96%) (Table 1), and is one of the most reliable serological COVID-19 ELISA tests on the market (Table 2). In the evaluation of cross-reactivity with IgG antibodies of other viruses, the test shows remarkable specificity (Table 3).

The Actim ELISA SARS-CoV-2 IgG test is an enzyme-linked immunosorbent assay (ELISA) which is carried out on a test plate coated with SARS-CoV-2 S1 proteins. The S1-specific antibodies in the serum or plasma sample bind to the plate with high specificity. This binding is recognized by a labeled detector antibody which is measured at 450 nm.

The test kit contains all required reagents and results are available in less than two hours.

SensitivitySpecificityPPVNPVAccuracy
96%98%87%99%98%
TABLE 1. Excellent performance of Actim ELISA SARS-CoV-2 IgG compared to RT-PCR in analysis of total 670 serum samples (≥ 7 days after PRC sampling).
MethodSensitivity
Actim ELISA SARS-CoV-2 IgG S196%
ELISA IgG, Competitor A70%
ELISA IgG, Competitor B72%
ELISA IgG, Competitor C80%
TABLE 2. Actim ELISA SARS-CoV-2 IgG has best-in-class sensitivity (n= 50 positive and 50 negative).
IgG:IgG:IgG:
AdenovirusMumps virus (parotitis)Varicella zoster virus
Cytomegalovirus (CMV)Mycoplasma pneumoniaeEpstein-Barr virus
Herpes simplex viruses 1+2Parainfluenza viruses 1/2/3Enteroviruses
Influenza virus Type AParvovirus B19Measles virus
Influenza virus Type BRespiratory syncytial virusHantavirus Pool 1 “Eurasia”
Haemophilus influenzae B
Table 3. Actim ELISA SARS-CoV-2 IgG does not cross-react with IgG antibodies against 16 other viruses. The evaluation was made with 90 human serum samples collected before the COVID-19 pandemic.

How it helps

How Actim ELISA SARS-CoV-2 IgG helps

Actim ELISA SARS-CoV-2 IgG detects recent COVID-19 infection through measurement of the immune response to SARS-CoV-2. This allows tracing infection chains retrospectively and assessment of the proportion of asymptomatic infections which then provides essential epidemiological data for global and local monitoring of the pandemic and assessing the development of population immunity.

Furthermore, the test can be used in the development of vaccines against SARS-CoV-2 virus in order to confirm whether or not vaccine candidates provoke an immune response against COVID-19.

Actim ELISA SARS-CoV-2 IgG

  • Detects recent COVID-19 infection—even symptomless
  • Enables retrospective contact tracing
  • Helps in monitoring and restricting the spread of the pandemic
  • Provides information of the prevalence of SARS-CoV-2
  • Helps estimate progress towards population immunity
  • Can be used to investigate immune response to vaccine candidate

How to use it

How to use Actim ELISA SARS-CoV-2 IgG

Actim ELISA SARS-CoV-2 IgG test kit contains all reagents needed for testing and can be stored at 2–8 °C.

Before you begin

Mix all reagents gently but thoroughly prior to use. Avoid foaming.

Dilute 40 ml of 25x Wash Solution to a final volume of 1000 ml in Distilled/deionized water.

Dilute Samples, Controls (positive and negative), and Calibrators (A-F) 1:50 in Sample Diluent and mix thoroughly.

Dilute the 100x HRP-Conjugate 1:100 in Conjugate Diluent.

Assay procedure

Add 100 µl of diluted Samples/ Controls/ Calibrators to appropriate wells and incubate the plate at room temperature on a shaker for 30 minutes.

Wash the plate twice using 350 µl Wash Solution (1x) per well.

Add 100 µl of diluted HRP-Conjugate to each well and incubate the plate at room temperature on a shaker for 30 minutes.

Wash the plate six times using 350 µl Wash Solution (1x) per well.

Add 100 µl of Substrate to each well and incubate the plate for 10 minutes (precisely).  No shaking. Cover the plate to protect it from light. A blue colour develops in the wells.

Add 50 µl Stop Solution to each well.  Shake the plate for 5 seconds to mix. The solution changes from blue to yellow.

Read the plate at 450 nm.

How to order it

How to order Actim ELISA SARS-CoV-2 IgG

Actim ELISA SARS-CoV-2 IgG test kit contains everything needed for testing:

  • Microtiter plate 1 pcs (96 wells)
  • 100x HRP-Conjugate 175 µl
  • 50x Calibrator (A-F), 50 µl x6
  • 50x Control (Neg-Pos), 50 µl x2
  • Assay Buffer, 50 ml
  • 25x Wash Solution 100 ml
  • Substrate 20 ml
  • Conjugate Diluent 15 ml
  • Stop Solution 15 ml
  • Instruction for use
  • Certificate paper

Materials and equipment required but not provided in the kit: Distilled or deionised water, Microplate reader capable of measuring absorbance at 450 nm, Plate washer – automated or manual, Plate shaker, Calibrated, adjustable precision pipettes and tips, Glass or plastic tubes for preparation of required dilutions, Lid/cover for micro plate, Time

Ordering information:

  • Actim ELISA SARS-CoV-2 IgG | product code 35530ETAC

Materials

MDSAP 13485 and ISO 13485 certificates can be found here.

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