COVID-19 Trace™ IgG MICRO-ELISA Kit

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Product No.S1500
Formats AvailableView All
Product Type
ELISA Kit
Applications
ELISA Det
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S1500-90 Tests
90 Tests
$550.00
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Min: 1
Step: 1

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Product Details

Description
The COVID-19 TraceTM IgG MICRO-ELISA assay is designed to detect immunoglobulin class G (IgG) antibodies to the receptor binding domain (RBD) protein antigen of SARS-CoV-2 in serum and plasma from individuals who are suspected to have had coronavirus disease (COVID-19), or in serum or plasma from subjects infected by the virus SARS-CoV-2 but may be asymptomatic at the time of the test.

Leinco's SARS-CoV-2 MICRO-ELISA assay has completed Section IV.D notification process under FDA’s “Policy for Coronavirus Disease – 2019 Test During the Public Health Emergency (Revised)“ and has not been reviewed by FDA.

Please refer to product-specific insert for a complete description of COVID-19 TraceTM IgG MICRO ELISA Kit
Materials Provided
Refer to product-specific inserts for a complete list of contents for assay.
  • S1500-1: 1 Microplate 96-well strips (12 x 8 strips)
  • S1500-2: 1 Positive Control (1X) (0.5 ml)
  • S1500-3: 1 Negative Control (1X) (0.5 ml)
  • S1500-4: 1 Cutoff Control (1X) (0.5 ml)
  • S1500-5: 1 Sample Diluent (1X) (50 ml)
  • S1500-6: 1 Enzyme Conjugate (100X) (150 μl)
  • S1500-7: 1 Conjugate Diluent (1X) (12 ml)
  • S1500-8: 1 Wash Buffer (20X) (25 ml)
  • S1500-9: 1 Substrate Chromogen (1X) (12 ml)
  • S1500-10: 1 Stop Solution (1X) (10 ml)
  • S1500-11: 2 Adhesive Plate Sealers (2 x 1 each)
Storage Conditions
Unopened: This test kit must be stored at 2 – 8°C upon receipt. For the expiration date of the kit refer to the label on the kit box. All components are stable until this expiration date.

Opened: Once opened, the kit reagents are stable when stored at 2 – 8°C. Refer to label on the kit box for expiration date.

Indication of Instability or Deterioration: Deterioration of kit reagents may be indicated when a quality control value is out of the specified range. Associated test results are invalid, and samples must be retested with a new kit where the control values are within the specified ranges.
Recombinant Standards
Recombinant IgG Monoclonal Antibodies to SARS-CoV-2 RBD
Assay Procedure
The test procedure must be followed as written. Any deviations from this procedure may produce erroneous results. Refer to product-specific inserts for a complete step-by-step procedure.

  • Allow all kit reagents to stand for 30 minutes to reach room temperature18 – 30°C and gently mix each vial by vortexing on low speed or inverting 10 times.
  • The Positive Control, Negative Control and the Cutoff Control must be assayed in duplicate on the 96 well Microplate each time the test is performed. Up to ninety (90) test specimens may be ran in singlicate on each full plate.
  • Place sufficient microplate strip wells in a strip holder to run all assay controls in duplicate and test specimens in singlicate.
  • Pipette 100 μl of the diluted Positive Control, Negative Control and Cutoff Control into the individual microplate wells in duplicate.
  • Pipette 100 μl of the diluted Test Specimens into the corresponding individual microplate wells in singlicate.
  • Cover the plate with an adhesive plate sealer and incubate for 30 minutes at +37 °C ± 1 °C in an incubator without carbon dioxide. For manual processing of microplate wells, cover the finished test plate with an adhesive protective plate sealer and start incubation. When using automated microplate processors, for incubation, follow the recommendations of the instrument manufacturer.

  • CAUTION: Do not stack plates on top of each other. They should be spread out as a single layer for even temperature distribution.

  • Plate Washing: Remove the protective adhesive strip and aspirate each well and wash, repeating the process for a total of four washes. Wash by filling each well with 300 μl of 1X Wash Buffer using a manual squirt bottle, manifold dispenser, or autowasher leaving the 1X Wash Buffer in each well for 30 – 60 seconds. Complete removal of liquid at each step is essential for good performance. After the last wash, remove any remaining Wash Buffer by aspirating or decanting. Invert the plate and blot it against clean paper toweling.
  • Pipette 100 μl of diluted 1X Enzyme Antibody Conjugate into each micro-well previously incubated with the Controls and Test Specimens.
  • Place an adhesive plate sealer over the wells and incubate without carbon dioxide at (37°C + 1°C) for ± 1 minute.

  • CAUTION: Do not stack plates on top of each other. They should be spread out as a single layer for even temperature distribution.

  • Plate Washing: Remove the protective adhesive strip and aspirate each well and wash, repeating the process for a total of four washes. Wash by filling each well with 300 μl of 1X Wash Buffer using a manual squirt bottle, manifold dispenser, or autowasher leaving the 1X Wash Buffer in each well for 30 – 60 seconds. Complete removal of liquid at each step is essential for good performance. After the last wash, remove any remaining Wash Buffer by aspirating or decanting. Invert the plate and blot it against clean paper toweling.
  • Add 100 μl of Substrate Chromogen to each well. Incubate for 20 minutes at room temperature (18 – 30°C) protected from direct light.
  • Immediately upon concluding the 20 minute incubation, add 50 μL of Stop Solution to each well. The color in the wells should change from blue to yellow. If the color in the wells is green or the color change does not appear uniform, gently tap the plate to ensure thorough mixing.
  • Immediately after adding stop solution, at the 20 minute mark, read the absorbance from the color intensity of each well at 450 nm. Prior to measuring, carefully shake the microplate to ensure a homogeneous distribution of the solution in the wells.

  • CAUTION: The plate should be read at 20 minute +/- 1 minute. If not read within this time period, results may not be accurate. The test must be repeated.

Background

Chinese authorities identified an outbreak caused by a novel—or new—coronavirus termed SARS-CoV-2. The virus can cause mild to severe respiratory illness; known as Coronavirus Disease 2019 (COVID-19) formerly called 2019-nCoV.1 SARS-CoV-2 is different from six other previously identified human coronaviruses, including those that have caused previous outbreaks of Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS).

The SARS-CoV-2 Spike (S) Protein consists of the S1 and S2 domains.2 The S1 domain contains the receptor-binding domain (RBD) that can specifically bind to angiotensin-converting enzyme 2 (ACE2) receptors on target cells.2 The SARS-CoV-2 nucleocapsid (N) protein plays a role in transcription, replication, and packaging of the viral RNA genome, while also affecting host cell responses such as cell cycle and translation.3 SARS-CoV-2 is closely related to the SARS virus, which was first identified in 2002-2003.3 In-depth analysis has identified the SARS-CoV-2 RBD as being essential for ACE2 binding.3 Both SARS-CoV and SARS-CoV-2 utilize the ACE2 cellular receptor to gain entry into cells, with SARS-CoV-2 binding with higher affinity.4 Vaccine and therapeutic development are targeting portions of the spike protein, including the RBD portion.5

References & Citations

1. van Dorp L, Acman M, Richard D, et al. Emergence of genomic diversity and recurrent mutations in SARS-coV-2. Infec Genet Evol2020;83:104351. Doi:10.1016/j.meegid.2020.104351
2. Hoffmann et al., 2020, Cell 181, 271–280
3. Kang, S. et al. (2020) Acta Pharm Sin B. Apr 20. doi: 10.1016/j.apsb.2020.04.009
4. Wrappet al.Science: 2020.
5. Tai et al. Characterization of the receptor-binding domain (RBD) of 2019 novel coronavirus: implication for development of RBD protein as a viral attachment inhibitor and vaccine. Cellular & Molecular Immunology 17, 613 – 620. 2020.
Products are for research use only. Not for use in diagnostic or therapeutic procedures.
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