Does anyone else had trouble to get the hbsag count test done in the US?

[itac]

I live in California, and have Anthem Blue Cross HMO. Currently assigned to Regal Medical Group. It seems like they are contracted with a lab called Quest Diagnostics, that run all the blood test work.

I went to my PCP a week and a half ago to get the follow-up test for hep b, after having the initial test diagnosis.
I asked for hbsag count, hbv dna count, hbeag and hbeag antibody (I already got the rest). They took my blood and sent it to Quest.

Yesterday I finally got the full report of that test, and it only had hbv dna count in ui/ml, but there was nothing about hbsag count or hbeag/hbeag antibody. I called my PCP office, the nurse who took the blood said to call to Quest to clarify the results if I think something is missing. I wasted 2 hours on the phone with 3 different people from Quest Diagnostics, none of them knew what I was talking about (hbsag in ui/ml, hbeag, hbeag antibody). They say they couldn't find these tests on their list of tests they provide. How is it possible? I would think such basic tests should be available, but I guess it's not the case with Quest? Did anyone else had to run blood work with this lab and ran into similar issues?

I asked them to have a technical person or a medical director to call me back about the tests that I want that were not "available".

Other tests I asked them that about that they didn't have:
Hepatitis A IgG antibody (to see if I've been exposed to the virus), the only have the IgM once which only checks for a recent exposure, but it's pointless cause what if I want to get the vaccination and need to know if I don't have the virus already? Doesn't make any sense...

Another test I asked them about that my GI asked me to get at their lab was "Fibrosis blood test" which they also couldn't find in their list.

I also wanted them to test for Hepatitis D to see if I got a co-infection, they said they only have "Hepatitis D virus RNA qualitative PCR" test... Not sure if that's the one that test for it or is it something else?

I didn't even get to ask them about the hbv genotype test... which my guess they wouldn't have that as well...

I will wait for them call from them to get clarifications, but feel free to leave your comments if you had similar experience. Thanks!

[studyforhope]

It is possible to measure the hbsag with a quant elisa kit. But you need pipettes, a photometer or elisa reader, and some lab skills.

http://www.4adi.com/objects/catalog/product/extras/4110-HbSAg-flr.pdf

The accuracy is as good as your standards. This kit provides the standards in ng/ml. To calibrate them to international units you need to obtain at least once a sample of an NIBSC standard.
Serum samples need to be diluted into the measurable range of the assay. The actual hbsag concentration is then obtained by multiplying the tested sample with the dilution factor. Dilutions can be done very precisely if you have a good pipette and know how to do it properly.

But as I said, this is limited to persons with laboratory skills and some equipment.

[stef2011]

Think they have it architect is an old machine available since 2000 with kits for quantification and not qualitative.i dont think they are so mad in US to use even older machines because they dont get all hbsag types and gets false negative

the relatively new machine is elecsys from roches, this is better because it has automated dilution with no need of special kits.i m not sure but elecsys should be around since 2010

[itac]

I found the name of the machine that does this test:

ARCHITECT i 1000SR

https://www.abbottdiagnostics.com/en-us/products/ARCHITECT-i1000SR.html#test-menu

It provides many tests, including this one:

"ARCHITECT HBsAg Qualitative

Intended Use: The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum. The assay may also be used to screen for HBV infection in pregnant women to identify neonates who are at risk for acquiring hepatitis B during the perinatal period. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with the hepatitis B virus (HBV) (state of infection or associated disease not determined) in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis B infection. Not intended for use in screening blood, plasma, or tissue donors.

Important Safety Information: United States Federal Law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to, by, or on the order of a physician. Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert."

perhaps we should start a fund raiser website to order this machine for some lab in the us?

[itac]

Yes, I will try to get someone who speaks Spanish who can help me make the call to these labs...

By the way, I forgot to tell you guys I spoke with a medical director from Quest Diagnositics... He told me they might do the test in the liver transplant centers labs...

For example: UCLA, Ceder-Sinai, USC out-patient labs... Has anyone tried these options? I tried to call, but it seems like they only work on the weekdays... He said he will try to find out other places that might do it, and let me know... He said technically it's possibly to perform this simple/cheap test...

[mike9111]

Hbsag quantitative is a cheap test and much cheaper than hbv dna pcr test. In germany i paid 15 euro and i don't have insurance. In mexico 30 pesos seems so cheap that is less than 2 dollars according to what you say and i  hope she is right

[stef2011]

It would be best t, o have someone that speaks spanish, english is no good, the subject is too particular that is even difficult to explain using our native languages in our countries (i mean i had trouble in italy speaking italian when test was not wellknown/common in 2010)

[itac]

I just tried to call the first 3 numbers you gave...
The first number no one talks in english
second they said someone who talks english will be there on monday at 9am...
third one I spoke with some lady who said she spoke with the lab and they do the test... I think she said it costs 20-30pesos or something... not sure if she got the spelling correctly or not... I tried to get her to email me the information and she hung up lol...

Do you have the actual email addresses you used for english correspondence with them? It's gonna be hard to comminicate without some translator...

[stef2011]

Quality si the same everywhere as long as they have the abbott architect machine with automated kit for dilution, the problem is that many times the labs have the machines but biologists there know nothing about them, they press buttons but sometimes cannot understand correctly about automated dilution, manual dilution.if they make no dilution the results are useless because it says hbsag over >250iu/ml

it is also important to send blood correctly.years ago in italy they tested my sample for qualitative, then when i called them they maxe a mistake and that i could not go back they retested from the same sample left...the result was complitely wrong with hbsag concentration reported very high.

I shared these examples because it is best to get a biologist that knows about the test and machines very well and can suggest how to ship samples correctly

[jamesdc]

As I posted on May 15, the Guadalajara lab does not report in iu/ml.

I've given you all the information I have regarding what I know about the Abbott Labs in Mexico.

[itac]

"(52)3336690310
Guadalajara

As I stated before, Guadalajara does not report the result correctly. "

what do you mean by that? they don't give it in UI/mL?
Also, how can we know we can trust these labs and the accuracy of the tests and the quality of the blood when it's being shipped to them?

[jamesdc]

I found the response to my email I received from Abbott, Mexico:

We have some customer in the main cities of the country that they run this  test, I will  send you the information about where and which laboratories have available  this assay.

LABORATORY
TELEPHONE NUMBER
CITY
CLINICA DE MERIDA SA DE CV
52(999) 942-18-00
Merida
LABORATORIOS BIO-ANALISIS, S.C
(52)2223033100
Puebla
THE AMERICAN BRITISH COWDRAY
(52) 5552308121
Distrito Federal
UNIDAD DE SERVICIOS DE PATOLOGIA
(52)3336690310
Guadalajara

As I stated before, Guadalajara does not report the result correctly.

[itac]

Not sure which phone/email I should use in this link:

http://www.abbott.com/contact.html

Could please say which phone/email should I use to contact them? Specifically the lab who does the test, which you say is the one at Mexico City?

Thanks!

[jamesdc]

The lab in Guadalajara does not report the result in iu/ml. The lab in Mexico City was the one that I could not fully understand the reply. If I remember correctly, I used the Corporate HQ info on this link and they gave me the Mexico City contact info. It might take a little time to finally get to the right person to help.

http://www.abbott.com/contact.html

[itac]

Could you please give me their website/phone number? I can try to contact them... Thanks!

[jamesdc]

I contacted Abbott Mexico several months ago. They have labs in Merida, Puebla, Guadalajara and Mexico City that do the HBsAG quantitative test. I got in touch with the one in Mexico City but it got to be a hassle communicating, even with Google translator since I don't speak Spanish but it seemed they were open to accepting blood samples through FedEx or UPS. It was a few hundred dollars for the shipping but the test was fairly inexpensive. But again, I might not have clearly understood what they were emailing. You might try contacting one of the labs (if you don't speak Spanish, I would suggest having someone who does help you with the translation). Hopefully you'd be able to clarify their response.

[mike9111]

Hbsag quantitative is not approved by FDA in USA so we can't fet the results here.

[itac]

"Do you have NASH or nonalcoholic fatty liver disease (NAFLD) too?  I've never had this test for HBV, wondering if anyone else has??  Seems interesting and would be curious if this test is beneficial with HBV."

I'm not aware I have NASH or nonalcoholic fatty liver disease... I think he wants to use this for Fibrosis estimate...
But I just found on the Anthem Blue Cross site this:
http://www.anthem.com/medicalpolicies/policies/mp_pw_a050311.htm
they say this test is "Investigational and Not Medically Necessary" I'm afraid they might even cover it lol...

It seems like they applying some sort of algorithm based on other markers... so there is nothing really new with this test... and it's not proven to be very accurate if Anthem don't want to cover it or maybe they just don't want to pay for it...

"Conditions include alcoholic steatohepatitis (ASH) or alcoholic liver disease, cirrhosis, hemochromatosis, hepatic vein clots (thrombosis), hepatitis, hepatocellular carcinoma (liver cancer), nonalcoholic steatohepatitis (NASH) or fatty liver disease, and Wilson’s disease. - See more at: http://www.clpmag.com/2007/04/liver-diagnostics-too-little-too-late/#sthash.Qi2yZLTK.dpuf" - I found this... I wasn't sure which one he wanted me to do the ASH or NASH but it seems like quest only do the NASH one:

http://www.questdiagnostics.com/testcenter/BUOrderInfo.action?tc=18692&labCode=AMD

Because I think the NASH one is for Non-Alchaolic patients... Which I think fits me since I don't really drink... Worst case he will tell me it's not the one... But I think I'm gonna get a FibroScan just to be on the safe side...

Tomorrow I'm gonna go to my PCP and ask to get all missing blood work I got all the codes with me as mentioned above including this FibroSure... And I will try to ask the doc to get me a referral to FibroScan so I only pay $250 co-pay instead of $350 regular price... And I will try to find a place where I can get the hbsag quantity done... I still can't believe we can't get this done in the US... I spoke with 6-7 different labs today...

[stef2011]

It is crazy how they took away your freedom in US without you even getting noticed.what tests you want on your blood is none of government business and also what you want to do wit your blood, from free countries this thread sound from ridiculous to a movie when government controls your rights and freedom

i don Think you easily get an asnwer from drawing blood in mexici because it can be from free included in the test to extremely low cost

[twinboys1girl4me]

Do you have NASH or nonalcoholic fatty liver disease (NAFLD) too?  I've never had this test for HBV, wondering if anyone else has??  Seems interesting and would be curious if this test is beneficial with HBV.  

[itac]

Hi twinboys1girl4me,

I just spoke with the GI, he said by "firbrosis blood test" he meants "FibroSure" because he said I already had the AFP done...

I believe that's the test:

http://www.questdiagnostics.com/testcenter/BUOrderInfo.action?tc=18692&labCode=AMD

"his test is a noninvasive assessment of liver status in
patients with nonalcoholic fatty liver disease (NAFLD).
Quantitative results of 10 biochemicals, in combination
with age, gender, height, and weight, are analyzed using
a computational algorithm to provide a quantitative
surrogate marker (0.0-1.0) of liver fibrosis (Metavir
F0-F4), hepatic steatosis (0.0-1.0, S0-S3), and
nonalcoholic steatohepatitis (NASH) (0.0-0.75, N0-N2).
The absence of steatosis (S < 0.38) precludes the
diagnosis of NASH."

Any idea how accurate this one is?

[twinboys1girl4me]

Hi Itac,

This is what I wrote in my earlier post:

Is the Fibrosis blood test actually the AFP, which is to test for liver cancer (but not a high accuracy so not totally reliable)?  I can't think of another one, other than ALT, AST which are easy.  

You are right, AFP is to measure possible HCC, although it is only around 60-70% accurate.  This is why 6 months scans (US, MRI, CT) are combined with AFP.  I do not know what test he was referring to for fibrosis, especially in regards to a blood test.  I would contact your doctor and ask about clarification for this.

Others did mention Fibroscan, which is an ultrasound and does not have any radiation, that measures fibrosis.  Another test, a liver biopsy measures fibrosis, but this is an invasive outpatient procedure.  Most outside of the US do Fibroscan because of it's high accuracy and non-invasive testing.  However, in the US most doctors still do biopsies but slowly are starting to come around to Fibroscan.  

[itac]

Sure, I will let you know if I find anything...

Btw, about what you said here:

"As for the AFP the Quest code I have is 8918, but do not think this is your code because I've compared your other codes and are different than mine.  I know each code is different based on lab location.  The test name for AFP Quest is Alpha-Fetoprotein, Tumor Marker."

I actually I found that I did have this test in my follow up testing:
ALPHA FETOPROTEIN
TUMOR MARKER                2.0           Reference Range<6.1 ng/mL

So I'm confused I brought this test results to the GI (that was my first and only appointment with him), yet he gave me to do the "fiborosis blood test" which is you say is the same as the AFP test? I'm kinda confused now...
Isn't tumor (AFP) is checking for cancer while fiborosis is something else? Or they are actually the same thing?

[twinboys1girl4me]

No, when I got next month I thought I would ask.  They probably will think I'm crazy since I know it's not common in the US to be in our situation, having to go elsewhere for tests.  You let us know if I have luck, but not holding my breath.

I was e-mailing a few from Algodones, Mexico since I know many in AZ go there for dental, prescriptions, vision, etc.  I e-mailed two earlier this week but have not gotten a response.  Many in Algodones have websites since they market to Americans but don't think most in Tijuana do.  I will let you know if I have any luck from there.  I cannot just go down to Mexico and ask and hope it works out, so I need to plan this out for sure before hand.  Please let me know if you find any luck and I will too.

[itac]

Have you tried to ask the PCP nurse to withdraw your blood and give you the tube?
Also, what Mexico lab is it? Is it in Tijuana?