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FDA EUA Filed & CE/IVD Marked

QuantiVirus™ Anti-SARS-CoV-2 IgG Test Kit

 

The IgG test is a high-throughput antibody test (serology) aims to accurately detect immune response to SARS-CoV-2 exposure

 

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The QuantiVirus™ Anti-SARS-CoV-2 IgG Test is an immunoassay test intended for the qualitative detection of anti-SARS-CoV-2 IgG from serum or plasma from individuals suspected of COVID-19 by their healthcare provider. This test is to check if the COVID-19 virus antibody is present due to virus infection.

Looking for the RT-PCR test (nucleic acid test for viral RNA) to detect current infection with SARS-CoV-2? 

Product Highlights

  • FDA Emergency Use Authorization (EUA) Filed (submission #: 201890)
  • CE/IVD Marked
  • High throughput: 92 samples per run
  • Sample type: Serum or EDTA plasma
  • Sample input: 10 uL
  • Turnaround time: 3 hours

Clinical specificity and sensitivity

  • Clinical specificity: 98.25% (95% CI: 95.97% to 99.43%) 
  • Clinical sensitivity: 96.77% (95% CI: 88.83% to 99.61%)

Validated Machines

Luminex 200 and MAGPIX

COVID-19 Hotline

Email: covid19support@diacarta.com

Phone #: +1 510-878-6662, option 4 (tech support) 

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Product Configuration

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Kit Components

  • Capture beads 
  • 20x anti-human IgG antibody
  • Positive control and negative control 
  • Wash buffer and assay buffer
  • 96-well plate and plate seals
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Pack Size

96-reaction per kit, 384-reaction per kit, 960-reaction per kit

*This product configuration image only shows the 96-reaction pack size. Please refer to product IFU for 384-reaction and 960-reaction pack size kit configuration.

How Does the QuantiVirus™ Anti-SARS-CoV-2 IgG Test Kit Work?

The QuantiVirus™ Anti-SARS-CoV-2 IgG Test is a two-step immunoassay using the Luminex MagPix® platform for the qualitative detection of anti-SARS-CoV-2 spike protein 1 (S1) RBD IgG antibody in human serum or plasma (EDTA) specimens. Recombinant spike protein 1 (S1) RBD is covalently coupled to the surface of MagPlex® Microspheres (also called “beads”) via a carbodiimide linkage.
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First, S1 RBD coated beads and human specimens are mixed and incubated at room temperature for 1 hour, allowing the coated beads to capture the IgG antibodies present in human specimens.

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After washing, Phycoerythrin (PE) conjugated anti-human IgG is added to reaction mixture and incubated at room temperature for 30 minutes.

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After washing, PE fluorescence of each well in a 96-well plate is measured on Luminex MagPix® platform as Median Fluorescence Intensity (MFI).

Step 1

Capture beads and sample incubation at room temperature (1 hour)

Step 2

Anti-human IgG antibody incubation at room temperature (30 minutes)

Step 3

Plate reading & data acquisition

Assay Performance

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Assay Precision

The average CV% of within run precision was 8.25% (from 4.71% to 11.74%). The average CV% of between-run precision was 10.47% (from 5.0% to 13.4%)

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Assay Specificity

No cross-reactivity was observed to HIV, HAV, HBV, RSV, CMV EBV, Rubella, Influenza A, and Influenza B.

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Clinical Performance

The total clinical specificity and sensitivity was 98.25% (95% CI: 95.97% to 99.43%) and 96.77% (95% CI: 88.83% to 99.61%), respectively

 Ordering Information

US Customer Ordering Information (FDA EUA Filed)

Product Name: QuantiVirus™ Anti-SARS-CoV-2 IgG Test Kit

96-Reaction Kit Catalog Number: DC-11-0027
384-Reaction Kit Catalog Number: DC-11-0028
960-Reaction Kit Catalog Number: DC-11-0029

The FDA EUA version and CE/IVD version have the same contents & configuration. Labelling is the only difference between the two versions.

Outside US Customer Ordering Information (CE/IVD Version)

Product Name: QuantiVirus™ Anti-SARS-CoV-2 IgG Test

96-Reaction Kit Catalog Number: DC-11-0022E
384-Reaction Kit Catalog Number: DC-11-0023E
960-Reaction Kit Catalog Number: DC-11-0024E

The FDA EUA version and CE/IVD version have the same contents & configuration. Labelling is the only difference between the two versions.

COVID-19 Total Solution

DiaCarta offers a COVID-19 total solution to support the fight against COVID-19, including the RT-PCR test, antibody IgG test, CLIA lab service, sample collection kits, RNA control and more. 

QuantiVirus™ SARS-CoV-2 Test Kit (Detects 3 genes)

QuantiVirus™ SARS-CoV-2 Multiplex Test Kit (Detects 1 gene)

QuantiVirus™ Anti-SARS-CoV-2 IgG Test Kit

CLIA Lab COVID-19 Diagnostics Service

Nasal Sample Collection Kit for COVID-19

Saliva Sample Collection Kit for COVID-19

Need Help?

Call us: +1 (800) 878-6662

Email us: information@diacarta.com

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