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Avatar universal

Might have found a place in the US that does hbsag quant, but got a question:

I spoke with the lab technician, he told me they use Abbott Architect machine for the test.
But he said the hbsag quant comes in the signal to cut off format... not ui/ml... (like the hbsab quant or hbv dna quant)...

So can this can be helpful? Is there a way to convert the signal cut off to ui/ml?
Also, I tried to ask him about dilution, he said he wasn't aware of that, so not sure if that could affect the result as well... I got his email address for additional technical questions that I have... Please let me know what do you think I should ask him (if at all).

Once we'll confirm it's the real deal I'll share with you the name of the place.

Thanks!
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Avatar universal
Was anyone able to get the test done in Scantibodies (California)?

I found this (seems old news from 2012):
http://scantibodies.com/new_2012-04-18_new-tests/

"Please make a note that we just started offering the following tests which will be added to our menu in the near future:

    HBsAg Screen (surface antigen of the Hepatitis-B-Virus (HBV))
    Quantification of HbsAg, recombinant or native, in cell culture, bio-processing solutions, and or in other appropriately qualified samples from tissue (e.g., blood, saliva, mucosa). This assay is not intended for the diagnosis of Hepatitis B infection."

I remember I spoke on the phone with them couple of weeks ago, and the person I spoke with said they don't do this test, only for manufactures, so I'm wondering if there is a manufacturer or a doctor who is contracted with them, that might be able to request/order the test from them... I found some old post in the forum about a member mentioning that he's gonna check with them, but didn't follow up with the forum. I sent them an email (the one they mention in the link above), perhaps I could get a positive answer (if at all).
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Avatar universal
sorry, this slow download does not achieve a usable pdf file in either my ipsd or large samsung tablet. have to wait until i am back at my desktop.

you are right, a blood draw station will not even send a sample without a doctors order, much less make a dilution of the obtained serum.

and if you draw the blood yourself with butterfly needles and vacutainers from allegro medical, you still need a centrifuge for the serum and pipettes for the dilution and a sterile protein solution as diluent. btw they will not see that it is diluted. a serum that has no or a low anti hbsab inside can also be used as diluent.

But the lab will not accept a sample unless ordered by a doctor and sent by a blood draw station,  i assume. Maybe you can find a doc who will help you.
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Avatar universal
Ok assuming it's true then the challenge now is to find a place that does dilutions, and agrees to withdraw your blood, dilute it and send it to this lab. Does anyone have idea what lab this can done at preferably at California?

Studyforhope, can you please review the attached PDF:
http://www.speedyshare.com/wqKw6/HBsAg-Qualitative-1-2013.pdf
and see if there is a possibility this might not work? I don't know why you can't view it. Just copy the link to your browser, then hit enter to go to the site, choose "slow download", then a download of a PDF file will start (you will need Acrobat Reader to view it).
It says something about  1.0 S/CO is reactive in this manual, so my concern he might or another technician will just do it until 1.0... How we'll know it wil really be 1000 S/CO max? I guess I can try to get this test done there without dilution and see if it shows > 1000 S/CO... Another thing, if dilution is done, can they tell the blood they received is diluted?
Thanks!
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Avatar universal
He was not referring to automatic dilutions of the sample, but to other pipetting steps inside the machines reagents.
They simply do not dilute the sample and accept the upper limit, since everything is programmed and formalized.
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Avatar universal
I don't really understand how someone will be able take advantage of this place, as there is uncertainty how accurate this test is... He said that the machine does automatic dilutions, so that might mess up the result already since he dosen't take that into account.

I mean in theory your idea makes sense, but putting it into practice will be difficult unless you have private lab access or something. Also there lots of bereactusy involved. If someone is still interested, you can pm me for the info.
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Avatar universal
do you mind disclosing the name of this lab? It might be possible for some to use it after their serum had been prediluted, a ridiculously simple thing to do.
But i realize that the blood draw stations will not easily do that for you.

Also it might be possible to explain to that technician, that the absolute level of hbsag can be of importance in deciding the initiation of an interferon treatment, or to follow up an ongoing therapy to decide if it is worth to continue with it beyond 24 weeks.  The international literature and the meetings contain several presentations of this use of quant hbsag.
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Avatar universal
If you have the option just travel and do it. It is easy for me as my wife is german son i will go to germany in winter and get retested to see if im still at 223
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Avatar universal
I don't know where I can get dilutions to my blood before sending it to them... Plus I don't really trust this lab anymore since they don't really care about the quantity... I need to find another source... Thanks.
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Avatar universal
They are unwilling to perform any dilutions apparently. But you could send  two samples initially,  one undiluted and one with a 1 to 100 dilution before shipment. Then you will know the results up to 5000 in iu/ml if the formula is correct, which is likely, since a 0.05 iu/ml cutoff is common and if exactly used will provide a precise answer.

To establish the correctness of the Quant results a known sample should be sent once, this will verify and calibrate the procedure.

The package insert PDF did not open,  unfortunately.  It would be useful to check the details,  they might disclose and clarify beyond of what the lab technician wrote.
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Avatar universal
If he will provide only up to 1000 cut off index that means it's limited to 1000 * 0.055 = 55 ui/ml
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Avatar universal
That was his response:

"Almost all medical laboratory tests must be FDA approved usually done by the vendor (Abbott in our case), and any deviation from the established FDA-approved procedure requires extensive in-house testing validation. So, even if our units of S/CO can be simply converted to IU/mL, that has not established by the vendor and also, I believe is not commonly reported, and I’ve never encountered a physician requesting for our quantitative values in IU/mL units.



As for any dilutions required for this assay, this is probably performed automatically by the instrument. However, >=1.0 S/CO is a base cutoff for reactive samples, and as long as a result is greater than 1.0, it is considered reactive/positive and further dilutions would be unnecessary. If say there is a large amount of detected antigen present greater than the Analytical Measurement Range of the instrument, we would just report out as >1000.0 S/CO instead of trying to dilute it to get an exact quantitative result, since for treatment and diagnostic purposes, a positive Hepatitis B Surface Antigen is positive.



If you wish, see the attached PDF which is the package insert and instructions provided by our manufacturer for the Hepatitis B Surface Antigen test. If you have additional technical questions, I suggest you follow up with the vendor Abbot directly. However, for ordering and interpreting tests, you must consult your doctor first. Even though you may have a greater technical understanding than your doctor of how the test is performed and reported, your doctor is the best person in ordering necessary tests and interpreting my results into a larger scheme of things for treatment and diagnostic purposes."

He also attached this PDF to the email:
http://www.speedyshare.com/wqKw6/HBsAg-Qualitative-1-2013.pdf


Is it still worth pursuing this test at this lab? It sounds like he is not going to do dilutions if needed... Can the cut off index can still be useful in this case?
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Avatar universal
Can't believe you did it all the way to LA, there is no FibroScan in SF?
Btw, I will share it with you once I confirm it's real.
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Avatar universal
No one refered me to there i just paid the whole amount $350 from my pocket b/c scared of doing the biopsy.
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Avatar universal
How much did you pay for the FibroScan? My insurance told me there is a $250 co-pay as any other radiology, but it doesn't sounds right, because the full price is only $350 in the FibroScan Los Angeles place... So I can't believe they only cover one third of the price... It can't be the same as other radiology, cause frankly it's not really radiology is it? It's not CT, UT or MRI which the latter costs thousands of dollars, so then I understand the $250 co-pay, but FibroScan? Doesn't make any sense... Please let me know, thanks.
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Avatar universal
I am from the bay area I had my FIbroscan test in LA three month ago and now if you found a place where we can do the HBSAG quant test, I really don't mind to travel because life is beautiful. Appreciate for the efforts you are doing.
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Avatar universal
Thanks, I just emailed him these questions, let's see what's his response going to be.
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Avatar universal
The light emission units in the architect can be directly converted to the international units per ml.

In the eclesys machine the use voltage  induced chemilumescence and obtain first a signal to cutoff value from the sample, then multiply this ratio with .055 to obtain the iu/ml number.

It seems strange that he uses the cutoff ratio when they have an architect machine.

The dilution aspect of the test is simple to understand. There is a maximum intensity of light emission that falls within the linear range of the photo-multiplier. That limits the direct testing of a sample to 250 iu/ml.

Therefore if a sample has values above that, as determined by a first round of testing or because the approx value is known, a dilution is performed on the sample to reduce the hbsag to a value within the measurable range.

Dilution can be easily done manually, or automatic inside the machine, if it is equipped for that.

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Avatar universal
I just found this article:

http://www.journalofclinicalvirology.com/article/S1386-6532(11)00145-4/fulltext

A comparison of two assays for quantification of Hepatitis B surface Antigen in patients with chronic hepatitis B

"The obtained signal to cut-off index may then be converted to IU/mL using a WHO standard conversion factor of 0.055 IU/mL"

Is this conversion formula seems legit?

What else should I ask him about the test, what is this dilution in this test and what difference does it make, can someone explain please? Is he supposed to have a button on the machine that says "dilution"?
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