covid-img

COVID-19

Test for exposure to COVID-19.

 

Facts about COVID-19

  • The 2019 novel coronavirus disease (COVID-19) is a new virus of global health significance caused by infection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
  • COVID-19 is thought to spread from person to person in close contact through respiratory droplets
  • These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs. It is also possible that a person can catch COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes
  • Currently, previous testing for COVID-19 has included only a nasopharyngeal (NP) swab, which is tested for the presence of DNA from the virus

Facts about the Vibrant COVID-19 Panel

  • Vibrant has developed a novel test for COVID-19. Vibrant’s COVID-19 panel is a highly sensitive and accurate serum assay for viral antibodies.
  • Our test was internally developed and validated according to FDA EUA requirements. The independent review of this validation by the FDA is pending. This test does not require confirmation by CDC prior to reporting results
  • Vibrant’s COVID-19 ImmuneCheck looks specifically for IgM, IgA, and IgG antibodies against the spike proteins and 4 viral antigens of Covid-19 that will help assess your immunity against this novel virus

 

Why Test Antibodies to COVID-19?

Antibodies have been found to be highly sensitive biomarkers in infectious disease diagnosis. Previous studies on SARS, MERS, and more recently the ones on SARS-CoV2 have shown IgM antibodies to appear about 3 days from infection and IgG antibodies appear after 8 days. Profiling an individual’s antibody response is the only way to determine infections with few or no symptoms.

chart

Please note:

  • A patient cannot order their own tests
  • A doctor’s requisition is required for all testing

Not Available in New York state

Only healthcare providers licensed in their state may order laboratory testing.

IgM, IgG, and IgA Antibodies to:

  • SARS-CoV-2 Nucleoprotein
  • SARS-CoV-2 Spike Glycoprotein (S1)
  • SARS-CoV-2 Spike Glycoprotein (S2)
  • SARS-CoV-2 Receptor Binding Domain
Vibrant COVID-19 Ab
Clinical Diagnosis – NP
Swab Positive
Positive
Controls
Total
Analysis

(95% Confidence)
Overall
IgG/IgA/IgM
Positive
34
5
39
Sensitivity = 97.14% (85.47% – 99.50%)
Negative
1
300
301
Specificity = 98.36% (96.22% – 99.30%)
Total
35
305
340
Vibrant COVID-19 Ab
Clinical Diagnosis – NP
Swab Positive
Positive
Controls
Total
Analysis

(95% Confidence)
S1 SP IgG
 
Positive
24
3
27
Sensitivity = 68.57% (52.02% – 81.45%)
Negative
11
302
313
Specificity = 99.02% (97.15% – 99.67%)
Total
35
305
340
Vibrant COVID-19 Ab
Clinical Diagnosis – NP
Swab Positive
Positive
Controls
Total
Analysis

(95% Confidence)
S1 SP IgA
 
Positive
15
1
16
Sensitivity = 42.86% (27.98% – 59.14%)
Negative
20
304
324
Specificity = 99.67% (98.17% – 99.94%)
Total
35
305
340
Vibrant COVID-19 Ab
Clinical Diagnosis – NP
Swab Positive
Positive
Controls
Total
Analysis

(95% Confidence)
S1 SP IgM
 
Positive
28
2
30
Sensitivity = 80.00% (64.11% – 89.96%)
Negative
7
303
310
Specificity = 99.34% (97.64% – 99.82%)
Total
35
305
340
Vibrant COVID-19 Ab
Clinical Diagnosis – NP
Swab Positive
Positive
Controls
Total
Analysis

(95% Confidence)
RBD IgG
 
Positive
23
3
26
Sensitivity = 65.71% (49.15% – 79.17%)
Negative
12
302
314
Specificity = 99.02% (97.15% – 99.67%)
Total
35
305
340
Vibrant COVID-19 Ab
Clinical Diagnosis – NP
Swab Positive
Positive
Controls
Total
Analysis

(95% Confidence)
RBD IgA
 
Positive
18
2
20
Sensitivity = 51.43% (35.57% – 67.01%)
Negative
17
303
320
Specificity = 99.34% (97.64% – 99.82%)
Total
35
305
340
Vibrant COVID-19 Ab
Clinical Diagnosis – NP
Swab Positive
Positive
Controls
Total
Analysis

(95% Confidence)
RBD IgM
 
Positive
21
2
23
Sensitivity = 60.00% (43.57% – 74.45%)
Negative
14
303
317
Specificity = 99.34% (97.64% – 99.82%)
Total
35
305
340
Vibrant COVID-19 Ab
Clinical Diagnosis – NP
Swab Positive
Positive
Controls
Total
Analysis

(95% Confidence)
S2 SP IgG
 
Positive
28
1
29
Sensitivity = 80.00% (64.11% – 89.96%)
Negative
7
304
311
Specificity = 99.67% (98.17% – 99.94%)
Total
35
305
340
Vibrant COVID-19 Ab
Clinical Diagnosis – NP
Swab Positive
Positive
Controls
Total
Analysis

(95% Confidence)
S2 SP IgA
 
Positive
17
0
17
Sensitivity = 48.57% (32.99% – 64.43%)
Negative
18
305
323
Specificity = 100.00% (98.76% – 100.00%)
Total
35
305
340
Vibrant COVID-19 Ab
Clinical Diagnosis – NP
Swab Positive
Positive
Controls
Total
Analysis

(95% Confidence)
S2 SP IgM
 
Positive
31
1
32
Sensitivity = 88.57% (74.05% – 95.47%)
Negative
4
304
308
Specificity = 99.67% (98.17% – 99.94%)
Total
35
305
340
Vibrant COVID-19 Ab
Clinical Diagnosis – NP
Swab Positive
Positive
Controls
Total
Analysis

(95% Confidence)
NP IgG
 
Positive
25
4
29
Sensitivity = 71.43% (54.95% – 83.67%)
Negative
10
301
311
Specificity = 98.69% (96.68% – 99.49%)
Total
35
305
340
Vibrant COVID-19 Ab
Clinical Diagnosis – NP
Swab Positive
Positive
Controls
Total
Analysis

(95% Confidence)
NP IgA
 
Positive
13
1
14
Sensitivity = 37.14% (23.16% – 53.66%)
Negative
22
304
326
Specificity = 99.67% (98.17% – 99.94%)
Total
35
305
340
Vibrant COVID-19 Ab
Clinical Diagnosis – NP
Swab Positive
Positive
Controls
Total
Analysis

(95% Confidence)
NP IgM
 
Positive
24
1
215
Sensitivity = 68.57% (52.02% – 81.45%)
Negative
11
304
315
Specificity = 99.67% (98.17% – 99.94%)
Total
35
305
340
Vibrant COVID-19 Ab
Clinical Diagnosis – NP
Swab Positive
Positive
Controls
Total
Analysis

(95% Confidence)
Overall IgG
 
Positive
33
5
38
Sensitivity = 94.29% (81.39% – 98.42%)
Negative
2
300
302
Specificity = 98.36% (96.22% – 99.30%)
Total
35
305
340
Vibrant COVID-19 Ab
Clinical Diagnosis – NP
Swab Positive
Positive
Controls
Total
Analysis

(95% Confidence)
Overall IgA
 
Positive
23
3
26
Sensitivity = 65.71% (49.15% – 79.17%)
Negative
12
302
314
Specificity = 99.02% (97.15% – 99.67%)
Total
35
305
340
Vibrant COVID-19 Ab
Clinical Diagnosis – NP
Swab Positive
Positive
Controls
Total
Analysis

(95% Confidence)
Overall IgM
 
Positive
32
4
36
Sensitivity = 91.43% (77.62% – 97.04%)
Negative
3
301
304
Specificity = 98.69% (96.68% – 99.49%)
Total
35
305
340

The CDC reports that the following symptoms may appear 2-28 days after exposure:

  • Coughing
  • Fever
  • Shortness of breath
  • Shortness of breath
  • Gastrointestinal distress
    • Diarrhea
    • Abdominal cramping
  • Fatigue
  • Body aches
  • Headaches

In order to place an order for the Vibrant COVID-19 test panel, you must have a provider account with Vibrant America. If you already have an account, please log in to your provider portal here to place orders:

If you do not have a provider account but wish to open one, free of charge, please fill out the form below to create an account so that you may begin ordering:

  • No At-home collection or At-home testing
  • Vibrant COVID-19 Ab Assay should not be used to diagnose or exclude acute infection and should not be used as the sole basis for treatment or patient management decisions.
  • It is unknown how long IgM or IgG antibodies to SARS-CoV-2 will remain present in the body after infection and if they confer immunity to infection.

Regulatory Statement

The test has been validated but FDA’s independent review of this validation is pending. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. 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. Not for the screening of donated blood.