SARS-CoV-2 Immunoassay Test | SARS-CoV-2 Antibody Detection Kit

Detect SARS-CoV-2 Antibodies with a Novel Bioluminescent Immunoassay

The Lumit™ Dx SARS-CoV-2 Immunoassay is a qualitative in vitro diagnostic test intended to detect antibodies to SARS-CoV-2 in serum or plasma. The Lumit™ Dx assay platform is powered by the award-winning NanoLuc® Binary Technology (NanoBiT®)^1–3. With a simple workflow that includes no wash steps, the Lumit™ Dx SARS-CoV-2 Immunoassay offers consistent reliable results with a fast turnaround time.

To accommodate testing of large sample sets, this assay is compatible with use on many automated platforms.

The Lumit™ Dx SARS-CoV-2 Immunoassay (Cat.# VB1085) is available in the United States only.
For information about availability in other regions, please contact us.

A SARS-CoV-2 Immunoassay with a Simple and Fast Workflow

Whether you are a research lab utilizing antibody testing of SARS-CoV-2 to support population surveillance or a clinical lab reporting out the results of patient samples, the Lumit™ Dx SARS-CoV-2 Immunoassay, coupled with our GloMax® Instruments, offers simple and fast antibody detection. Performed at room temperature, the assay requires no wash steps and can go from sample to answer in under an hour.

Clinical Performance

The Lumit™ Dx SARS-CoV-2 Immunoassay performance is stratified by days post onset of symptoms using 168 samples collected from all subjects who tested positive for SARS-CoV-2 with an RT-PCR method with varying levels of disease. A positive percent agreement (PPA), or sensitivity, of 93.5% was obtained from 107 samples 20+ days post symptom onset in these subjects.

Samples from an additional subset of hospitalized subjects with a RT-PCR confirmed SARS-CoV-2 infection were tested with the Lumit™ Dx SARS-CoV-2 Immunoassay. A positive percent agreement (PPA), or sensitivity, of 100% was obtained from 31 samples 20+ days post symptom onset in these subjects.

Positive Percent Agreement By Days Post Symptom Onset, All Samples

Days Post Symptom Onset	n	Positive	Negative	PPA (95% CI)
0–7	39	30	9	76.9 (62–87)
8–19	22	16	6	72.7 (52–87)
20+	107	100	7	93.5 (87–97)

Positive Percent Agreement By Days Post Symptom Onset, Confirmed Hospitalized Subjects

Days Post Symptom Onset	n	Positive	Negative	PPA (95% CI)
0–7	39	30	9	76.9 (62–87)
8–19	20	14	6	70.0 (48–86)
20+	31	31	0	100 (89–100)

The Lumit™ Dx SARS-CoV-2 Immunoassay has a negative percent agreement (NPA), or specificity, of 99.4% as determined using 165 samples presumed negative for SARS-CoV-2. The assay has an NPA of 97.7% as determined using 43 samples that were collected from subjects who were exhibiting other illnesses.

Negative Percent Agreement

Category	n	Positive	Negative	NPA (95% CI)
Presumed Negative*	165	1	164	99.4 (97–100)
Other Illnesses**	43	1	42	97.7 (88–100)

*This cohort of samples was sourced from within the U.S. and presumed negative for SARS-CoV-2.
**Influenza A, Influenza B, Respiratory Syncytial Virus, Rhinovirus, Hepatitis B Virus, Hepatitis C Virus, Antinuclear Antibody (ANA), Haemophilus Influenza and HIV.

Comparator Method Agreement With US FDA EUA Authorized SARS-CoV-2 IgG Assay

A representative subset of 149 samples were further characterized using a US FDA EUA authorized SARS-CoV-2 IgG Assay (Abbott Architect SARS-CoV-2 IgG). The comparator IgG antibody assay uses a nucleocapsid target antigen and claims 100% PPA and 99.6% NPA with samples collected greater than 14+ days post-symptom onset⁴. Selected samples consisted of 60 samples that were confirmed positive using an RT-PCR method and collected from both non-hospitalized and confirmed-hospitalized patients 20+ days post-symptom onset as well as 89 presumed negative samples. Using this sample set, agreement between the methods was calculated with 95% confidence intervals.

Lumit™ Dx SARS-CoV-2 Immunoassay	SARS-CoV-2 Comparator Method
		Positive	Negative	Total
	Positive	51	3	54
	Negative	3	92	95
	Total	54	95	149
	Agreement	94.4%	96.8%
	95% CI	85–98	91–99

Optimize Your Workflow With Support From Our Automation Experts

Our Field Support Specialists are experts in major liquid handler types, including the Promega Maxprep™ Instrument, Hamilton Microlab STAR® series, Tecan Freedom EVO® and Fluent® series, Eppendorf epMotion® and Beckman Biomek® series. We offer prewritten and customized scripts and in-lab/remote assistance. Let us help optimize your current workflow or discuss automation solutions to fit your lab’s needs.

Learn More About Assay Automation

Lumit Dx Assay is compatible with many automation platforms

Novel Approach for Antibody Detection

In this Lumit™ Dx Immunoassay, a SARS-CoV-2-specific protein fragment is labeled with the two subunits of the NanoBiT® Luciferase (Lumit™ Dx CoV-2-SmBiT and Lumit™ Dx CoV-2-LgBiT). When these labeled proteins are incubated with a serum or plasma sample that contains SARS-CoV-2 antibodies, the proteins bind to the antibody, bringing the SmBiT and LgBiT subunits in close proximity to form an active luciferase. A bright luminescent signal is generated following the addition of the Lumit™ Dx Detection Reagent and detected using a luminescent-capable microplate reader.

The included calibrator is used to classify samples as positive or negative for SARS-CoV-2 antibodies with a simple calculation.

Lumit Dx SARS-CoV-2 Immunoassay detects COVID-19 antibodies with a luminescent signal

Faster, More Streamlined Workflow Compared to ELISA

Unlike conventional ELISA assays, the Lumit™ Dx SARS-CoV-2 Immunoassay requires no wash steps. This means less hands-on time, and allows you to move through the workflow faster. The assay can go from sample to results in approximately 1 hour. Using a SARS-CoV-2-specific antigen for detection may offer more robust specificity compared to that of many antibody-based assays.

Typical ELISA Assay Workflow

Conventional COVID-19 ELISA involves multiple wash steps

Lumit™ Dx SARS-CoV-2 Immunoassay Workflow

Lumit SARS-CoV-2-Immunoassay workflow is rapid and scalable

Sensitive and Reliable Detection with GloMax® Instruments and Analysis Software

The luminescent signal of the Lumit™ Dx SARS-CoV-2 Immunoassay can be easily detected using GloMax® Instruments. The assay and the GloMax® Instruments can be integrated with many liquid handling systems, offering increased throughput and time-savings.

GloMax® Navigator Details GloMax® Discover Details

GloMax Navigator detects the bioluminescent signal from the Lumit Dx Immunoassay

Medical Information

If you need assistance or access to medical information and resources, our Medical Affairs scientists are ready to help.

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Prepare your lab for flexible testing volumes with on-site access to products with no inventory carrying costs and free automated product replenishment.

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FAQ for Lumit™ Dx SARS-CoV-2 Immunoassay

What does the Lumit™ Dx SARS-Cov-2 Immunoassay detect?

The Lumit™ Dx SARS-CoV-2 Immunoassay detects antibodies against the Receptor Binding Domain (RBD) antigen within the S1 subunit of the SARS-CoV-2 spike (S) protein. Research has demonstrated that the spike (S) protein may offer better sensitivity than the nucleocapsid (N) protein for measuring SARS-CoV-2-specific antibodies⁵. In addition, many researchers have demonstrated that antibodies produced against the spike (S) protein, specifically produced against the RBD domain, are capable of viral neutralization^6–11.

What specimen type is needed for the Lumit™ Dx SARS-CoV-2 Immunoassay?

The assay should be performed with human serum or plasma.

How long does it take to get a result?

The assay can be run manually in 96-well format in less than an hour. Running the assay on an automated platform may expedite the time to result. The result for each sample is either positive or negative for SARS-CoV-2 antibodies, based on a calculation comparing patient sample to an assay calibrator.

Are specific instruments or equipment needed to run the Lumit™ Dx SARS-CoV-2 Immunoassay?

Yes. The luminescent signal should be detected on a luminescent-capable microplate reader. The Lumit™ SARS-CoV-2 Immunoassay has been validated on the GloMax® Navigator Microplate Luminometer, GloMax® Discover Microplate Reader and the CLARIOstar® Microplate Reader.

Where is this assay produced?

The Lumit™ Dx SARS-CoV-2 Immunoassay was developed in the United States at the Promega Headquarters in Madison, Wisconsin. This is also the location where all components and kit lots are manufactured, quality tested and distributed.

Do you have enough supply of reagents and consumable materials to manufacture the antibody test and allow laboratories to use it in large numbers?

We are confident in our abilities to manufacture the assay in large quantities to ensure the assumed demands for antibody testing for SARS-CoV-2 are met. In addition, we have secured a significant amount of raw materials at Promega Headquarters to meet demand.

References

European Laboratory Research and Innovation Group (ELRIG) – advances in cell based screening in Drug Discovery meeting 2015: Best Technology (https://elrig.org/advances-in-cell-based-screening-in-dug-discovery-2015-technology-prize/).
The Scientist: Top10 Innovation 2015 (https://www.the-scientist.com/features/top-10-innovations-2015-34435).
Dixon, A.S., et al. (2016) NanoLuc Complementation Reporter Optimized for Accurate Measurement of Protein Interactions in Cells. ACS Chem Biol. 11, 400–408.
FDA (2020) EUA Authorized Serology Test Performance: Abbott Architect SARS-CoV-2 IgG. Accessed August 25, 2020. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/eua-authorized-serology-test-performance.
Kontou, P. I., et al. (2020) Antibody Tests in Detecting SARS-CoV-2 Infection: A Meta-Analysis. Diagnostics (Basel). 10, doi:10.3390/diagnostics10050319 (2020).
Premkumar, L., et al. (2020) The receptor binding domain of the viral spike protein is an immunodominant and highly specific target of antibodies in SARS-CoV-2 patients. Sci Immunol, 5, doi:10.1126/sciimmunol.abc8413 (2020).
Ju, B., et al. (2020) Human neutralizing antibodies elicited by SARS-CoV-2 infection. Nature, doi:10.1038/s41586-020-2380-z (2020).
Shi, R., et al. (2020) A human neutralizing antibody targets the receptor binding site of SARS-CoV-2. Nature, doi:10.1038/s41586-020-2381-y (2020).
Rogers, T. F., et al. (2020) Isolation of potent SARS-CoV-2 neutralizing antibodies and protection from disease in a small animal model. Science (New York, N.Y.), doi:10.1126/science.abc7520 (2020).
Seydoux, E., et al. (2020) Analysis of a SARS-CoV-2-Infected Individual Reveals Development of Potent Neutralizing Antibodies with Limited Somatic Mutation. Immunity, doi:10.1016/j.immuni.2020.06.001 (2020).
Brouwer, P. J. M., et al. (2020) Potent neutralizing antibodies from COVID-19 patients define multiple targets of vulnerability. Science (New York, N.Y.), doi:10.1126/science.abc5902 (2020).

Intended Use Statement

The Lumit™ Dx SARS-CoV-2 Immunoassay is a qualitative in vitro diagnostic test intended for the detection of antibodies to SARS-CoV-2 in serum or plasma, utilizing a novel, proprietary detection system.

The Lumit™ Dx SARS-CoV-2 Immunoassay is indicated in conjunction with clinical presentation and the results of other laboratory tests as an aid in identification of patients with recent or prior SARS-CoV-2 infection. Results from the test should not be used as the sole basis for diagnosis or to exclude SARS-CoV-2 infection. See clinical sensitivity data for days post symptom onset of positive results observed. Positive results will occur only after infection and are indicative of recent or prior infection. False positive results can occur due to cross-reactivity from pre-existing antibodies or other possible causes.

Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests.

For prescription use only. For in vitro diagnostic use only.

Reports to healthcare providers should include the following information: Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary. Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. This test should not be used for screening of donated blood.

This test has not been reviewed by the FDA.

Protocols

Complete Protocol

Lumit™ Dx SARS-CoV-2 Immunoassay Technical ManualPDF (1991 KB) – English

What's in the box?

Item	Part #	Size
Lumit™ Dx CoV-2 LgBiT	VB104B	1 × 70μl
Lumit™ Dx CoV-2 SmBiT	VB105B	1 × 70μl
Lumit™ Dx Negative Control	VB106A	5 × 200μl
Lumit™ Dx Positive Control	VB107A	5 × 200μl
Lumit™ Dx Assay Calibrator	VB112A	5 × 200μl
Lumit™ Dx Immunoassay Dilution Buffer, 10X	VB113B	1 × 25ml
Lumit™ Dx Detection Substrate	VB114B	1 × 1.25ml
Lumit™ Dx PBS/EGTA Solution	VB116B	2 × 125ml

SDS

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Certificate of Analysis

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Use Restrictions

For In Vitro Diagnostic Use. This product is only available in certain countries.

Storage Conditions

Patents and Disclaimers

U.S. Pat. Nos. 9,797,889, 9,797,890 and other patents and patents pending.

U.S. Pat. No. 8,809,529, European Pat. No. 2635582 and other patents and patents pending.

Resources

Articles

SARS-CoV-2 and the Antibody Response in COVID-19 Patients

Other Resources

Frequently Used With

GloMax® Navigator System

Dedicated microplate luminometer.

GM2000, GM2010

GloMax® Discover System

High-performance microplate reader for detecting luminescence, fluorescence and absorbance.

GM3000

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Lumit™ Dx SARS-CoV-2 Immunoassay

Bioluminescent In Vitro Diagnostic (IVD) Test for SARS-CoV-2 Antibody Detection

Detect SARS-CoV-2 Antibodies with a Novel Bioluminescent Immunoassay

A SARS-CoV-2 Immunoassay with a Simple and Fast Workflow

Clinical Performance

Positive Percent Agreement By Days Post Symptom Onset, All Samples