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cPass New Antibody Test

Posted by joko @joko, Aug 17, 2021

Is anyone at Mayo considering this cPass test for antibodies? Does it actually measure a percentage or level of antibodies? I'm not sure from this press release if it would be worth it? Anyone else heard of it or tried it? https://www.prnewswire.com/news-releases/cpass-a-new-antibody-test-shows-your-bodys-response-to-the-covid-19-vaccine-301350758.html

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jackhickey | @jackhickey | Mar 11, 2023

Qualitative and semi-quantitively(threshold YES, 250, etc. I had a lab in San Jose which gave me a 250 response when I demand more than a YES.

Dear Friends,

Thank you for trusting us over the past few months with your COVID testing needs. With restrictions being eased for international travelers across the globe, we understand that you may be getting ready to visit your family and friends, and celebrate the New Year with your loved ones.

To express our sincere gratitude, we are now offering a 50% discount on our COVID-19 tests for new appointments until March 15, 2023. We know your travel plans might change so we will waive the cancellation fee when you schedule your appointment using this discount code.
Please use promo code NEWYEAR-r6B0H-22 when scheduling your appointment.

As a reminder, in addition to our San Jose site, TargetDx now has a collection site close to the San Francisco- SFO International airport:
Holiday Inn Express San Francisco Airport-North
Strategy Room, 2nd Floor
373 South Airport Blvd, South San Francisco, CA 94080.

The San Francisco collection site will be available until January 31, 2023, 8 AM- 11:30 AM PT to support your travel testing needs.

We hope to see you at our lab again. Happy New Year to you, and your loved ones!

With Utmost Appreciation,
Your TargetDx Team

Phone: 219-510-0120
Email: info@targetdxlab.com
Web: http://www.targetdxlab.com
TargetDx Laboratory

6541 Via Del Oro, Suite B, San Jose, CA 95119

December 16, 2021
Michael Lau
Director of Corporate Strategy

GenScript USA Inc.
860 Centennial Ave
Piscataway, NJ 08854
Device: cPass SARS-CoV-2 Neutralization Antibody Detection Kit
EUA Number EUA201427
Company: GenScript USA Inc.
Indication: Qualitative and semi-quantitative direct detection of total
neutralizing antibodies to SARS-CoV-2 in human serum and
dipotassium EDTA plasma. Intended for use as an aid in
identifying individuals with an adaptive immune response to
SARS-CoV-2, indicating recent or prior infection. Emergency use
of this test is limited to authorized laboratories.
Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet
requirements to perform high complexity tests.

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jackhickey | @jackhickey | Mar 11, 2023
In reply to @merpreb "This is what this tests shows, so that you know for yourself: Test Details Use Qualitative..." + (show)
@merpreb

This is what this tests shows, so that you know for yourself:

Test Details
Use

Qualitative and semi-quantitative detection of antibodies to SARS-CoV-2 spike protein receptor-binding domain (RBD). Aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The performance of this test has not been established in individuals that have received a COVID-19 vaccine. The clinical significance of a positive or negative antibody result following COVID-19 vaccination has not been established and the result from this test should not be interpreted as an indication or degree of protection from infection after vaccination.
Limitations

This test should not be used to diagnose or exclude acute SARS-CoV-2 infection. The results should always be assessed in conjunction with the patient's medical history, clinical presentation, and other findings. A negative test result does not rule out the possibility of an infection with SARS-CoV-2. Serum or plasma samples from the very early (pre-seroconversion) phase can yield negative findings. Therefore, this test cannot be used to diagnose acute infection. It has also been reported that certain patients with the confirmed infection do not develop SARS-CoV-2 antibodies. Furthermore, the waning of antibody titers has been reported in some individuals within a range of months after infection, a feature which has also been reported for other coronaviruses.

This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA). This test is only authorized for the duration of the declaration that circumstances exist, justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens.
Methodology

This test shows only detects that you have antibodies, but not the significance of the number or what the number means.

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I just want to know my antibody level, 2 years after my one and only J&J vaccine. Kaiser(They use Stanford Healthcare Lab) only provides a positive or negative, yet their equipment is capable of readings >2500. FDA directives are suppressing release of quantitative results to the public. I did get a lab in San Jose(Target DX) to report the semi-quantitative (>250) 1year after my J&J vaccination.

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1 reply
Merry, Alumni Mentor | @merpreb | Mar 11, 2023
In reply to @jackhickey "I just want to know my antibody level, 2 years after my one and only J&J..." + (show)
@jackhickey

I just want to know my antibody level, 2 years after my one and only J&J vaccine. Kaiser(They use Stanford Healthcare Lab) only provides a positive or negative, yet their equipment is capable of readings >2500. FDA directives are suppressing release of quantitative results to the public. I did get a lab in San Jose(Target DX) to report the semi-quantitative (>250) 1year after my J&J vaccination.

Jump to this post

Why aren't you getting this information from your doctors? I'm assuming that you have.

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1 reply
jackhickey | @jackhickey | Mar 23, 2023
In reply to @seaspray "The test I was given at Mayo is SARS-COV-2 SPIKE AB, SEMI-QUANT,S Component Results: Interp. S..." + (show)
@seaspray

The test I was given at Mayo is SARS-COV-2 SPIKE AB, SEMI-QUANT,S
Component Results: Interp. S = Positive
Quant, S = 561 U/ml
I know several people who have had this test done here at Mayo. Numbers vary but all were vaccinated early in the year.
Sorry if this does not help here......

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S = 561 U/ml is quantitative. Positive, >250, >2,500, etc. is semi-quantitative.

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jackhickey | @jackhickey | Mar 24, 2023
In reply to @contentandwell "@merpreb I think that is the test being used by JH. I know that MGH will..." + (show)
@contentandwell

@merpreb I think that is the test being used by JH. I know that MGH will not give me an order for an antibody test but my PCP did the last time. I hope she will again, I think it does give us some indication if that third shot has helped.
JK

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Was your PCP able to find a lab which would release the quantitative data?

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jackhickey | @jackhickey | Mar 24, 2023
In reply to @contentandwell "@sueinmn I did have their antibody test. I went to LabCorp which is the lab they..." + (show)
@contentandwell

@sueinmn I did have their antibody test. I went to LabCorp which is the lab they are using, and had the test that they use. This was about 5 or 6 weeks after my second shot and my antibody number was 13.83 which is pretty low. I hope my PCP will write the order for me to get it again, if not I will have to pay for it myself.
JK

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Which Labcorp did you use, and when?

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jackhickey | @jackhickey | Mar 24, 2023

LabCorp antibody test for Covid from their website:
Can semi-quantitative COVID-19 antibody test be used to track antibody levels overtime?
On May 19, 2021, the FDA issued a safety communication reiterating that “antibody testing should not be used to evaluate a person’s level of immunity or protection from COVID-19 at any time, and especially after the person received a COVID-19 vaccination.”4 Currently authorized SARS-CoV-2 antibody tests, including the SARS-CoV-2 Semi-Quantitative Total Antibody assay (164090), have not been evaluated to assess the level of protection provided by an immune response to COVID-19 vaccination. Additionally, the components of a protective immune response against infection or re-infection with SARS-CoV-2 have not been fully characterized (e.g., antibody, T cell, etc.). Clinical trials and other studies are underway to elucidate the correlates of immunity to SARS-CoV-2.

Effective March 28, 2022 Labcorp expanded the reporting range of results for test number 164090 SARS-CoV-2 Semi-Quantitative Total Antibody, Spike. Results previously reported for this assay were 0.8-2500 U/mL with higher values reported as >2500 U/mL. With the addition of an automated dilution, we are now able to report result 0.8-25000 U/mL with higher values reported as >25000 U/mL. This change does not impact previously reported results; it just increases the numerical values above 2500 U/mL that we are able to report.

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1 reply
jackhickey | @jackhickey | Mar 24, 2023
In reply to @jackhickey "LabCorp antibody test for Covid from their website: Can semi-quantitative COVID-19 antibody test be used to..." + (show)
@jackhickey

LabCorp antibody test for Covid from their website:
Can semi-quantitative COVID-19 antibody test be used to track antibody levels overtime?
On May 19, 2021, the FDA issued a safety communication reiterating that “antibody testing should not be used to evaluate a person’s level of immunity or protection from COVID-19 at any time, and especially after the person received a COVID-19 vaccination.”4 Currently authorized SARS-CoV-2 antibody tests, including the SARS-CoV-2 Semi-Quantitative Total Antibody assay (164090), have not been evaluated to assess the level of protection provided by an immune response to COVID-19 vaccination. Additionally, the components of a protective immune response against infection or re-infection with SARS-CoV-2 have not been fully characterized (e.g., antibody, T cell, etc.). Clinical trials and other studies are underway to elucidate the correlates of immunity to SARS-CoV-2.

Effective March 28, 2022 Labcorp expanded the reporting range of results for test number 164090 SARS-CoV-2 Semi-Quantitative Total Antibody, Spike. Results previously reported for this assay were 0.8-2500 U/mL with higher values reported as >2500 U/mL. With the addition of an automated dilution, we are now able to report result 0.8-25000 U/mL with higher values reported as >25000 U/mL. This change does not impact previously reported results; it just increases the numerical values above 2500 U/mL that we are able to report.

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Thanks to your governments efforts to protect you from misinformation which you might misinterpret!

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jackhickey | @jackhickey | Aug 31, 2023
In reply to @merpreb "Why aren't you getting this information from your doctors? I'm assuming that you have." + (show)
@merpreb

Why aren't you getting this information from your doctors? I'm assuming that you have.

Jump to this post

My doctor's response:
Hi!
So this is weird and slightly annoying
I asked for an IgG and an IgM, so we can differentiate.
They ran the test, but the result wasn't a 'yes IgG no IgM' but rather just a 'yes'
I'm going to have to ask if they broke the results down.

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