Author Topic: I am Confused with test results (Read 50274 times)

sohopeful · « **on:** January 30, 2015, 10:41:54 pm »

Hello all,
I started Harvoni on 11/27/14. I had my 8 week blood test on Monday of this week. Doctor calls today and said I was undetected. I am so happy!!!!!

Then this evening I printed my lab results from Quest and this is what is had listed.
HCV RNA, Quantitative Real Time PCR <15 Detected
HCV RNA Quantitative Real Time PCR <1.18 Detected
So what does this mean? The doctor says I'm undetected and the results say detected. Help! I am so confused!

badbradley · « **Reply #1 on:** January 30, 2015, 11:33:26 pm »

Hi sohopeful,
There are others on here that can explain more thoroughly than I can. Anyone?

Lynn K · « **Reply #2 on:** January 31, 2015, 01:08:08 am »

Hi

Not to disagree with your doctor but technically it means there is very little virus present <15 IU/mL (units per milliliter of blood) but it can still be detected just barely. Don't worry many have had similar results and gone on to become UND once they complete treatment. If you want you could ask your doctor to explain what you are reading but I am sure he didn't want to worry you as the odds are in your favor.

How many weeks are you treating for? Do you have cirrhosis?

Good luck

sohopeful · « **Reply #3 on:** January 31, 2015, 01:45:48 am »

Thanks Lynn,

I am treating for 24 weeks. Yes I do have cirrhosis. I'm going to call my dr. and just ask exactly what my test results mean.
Thanks again!

sohopeful · « **Reply #4 on:** January 31, 2015, 01:51:32 am »

Lynn K,
Why did you start taking Riba with Harvoni? Just curious. I see you will finish in May. I finish May 13th.

Sohopeful

Lynn K · « **Reply #5 on:** January 31, 2015, 01:59:24 am »

I wouldn't worry at all about the very low just barely detectable result if you are treating for 24 weeks.

If you noticed my treatment history you may notice I was a 3 time null responder to interferon based treatments and I relapsed after 12 week of treatment with Sovaldi Olysio plus I have had cirrhosis for 7 years. What is not mentioned is I have had symptoms of cirrhosis as well pitting edema, a small amount of ascities, platelet count of 90, enlarged spleen, portal hypertension, and I had esophageal varicies that required banding.

So based on all that we are trying to give me the best opportunity for a cure.

Have you been treated before or are you treatment naive? How long have you known you have cirrhosis? Do you have symptoms?

DisabledHepcat · « **Reply #6 on:** January 31, 2015, 02:11:11 am »

Read it, it says HCV RNA, Quantitative Real Time PCR <15 Detected.
It says less than 15 detected, The test cannot read anything below 15.
So the test says you are undetected above 15.

Now a HCV QUALITIVE test can read as low as 5.3, a qualitative test is more accurate and is used as a positive/negative result.
Either way you are undetected above 15.
Get tested again in 3-6 months to verify you are cured.

http://www.questdiagnostics.com/testcenter/testguide.action?dc=CF_ViralHepatitis

87521 HCV RNA, Qualitative TMA Confirm EIA diagnosis of acute or chronic infection (LOD = 5.3 IU/mL)
Differentiate between resolved and active infection
Demonstrate resolution of infection

86692
Hepatitis C Viral RNA, Quantitative, Real-Time PCR
Confirm active HCV infection and establish baseline viral load
Assess prognosis (prior to the initiation of therapy)
Monitor response to therapy
Linear range: 15 - 100,000,000 IU/mL
LOD: 10-13 IU/mL

Lynn K · « **Reply #7 on:** January 31, 2015, 02:23:53 am »

Hi Hep Cat

So hopeful is on week 8 of 24 weeks. The test result was:

HCV RNA, Quantitative Real Time PCR <15 DETECTED.

This was my 4 week test result and what an undetected test result looked like including the notes:

HCV RNA RT-PCR, QT HCV Not Detected

See Notes IU/mL See Below

The quantitative range of the assay is 15 IU/mL to 100 million IU/mL
using COBAS(R) TaqMan(R) HCV test, v 2.0. The limit of detection (LOD)
and lower limit of quantification (LLOQ) for this assay is 15 IU/mL.
Results less than the quantitative range of the assay will be reported
as "HCV RNA detected, less than 15 IU/mL".

Have a good one

DisabledHepcat · « **Reply #8 on:** January 31, 2015, 02:34:33 am »

Lynn, that looks like what a qualitative test result looks like, are you sure the QT is not qualitative? because a quantitative will only show detected above 15 since how can it detect something it cannot read? If a quantitative test is positive it would read at least 16. DOH !

Lynn K · « **Reply #9 on:** January 31, 2015, 02:51:48 am »

yes qualitative and per the notes

Results less than the quantitative range of the assay will be reported
as "HCV RNA detected, less than 15 IU/mL"

So the test can't quantify the result as in count the little buggers but the test knows they are there "HCV RNA detected"

Say they can't see them and count their little noses but the test can still smell them.

And like my most recent test on 12/16 after 4 weeks on treatment with Harvoni shows the test same test cannot even smell them any more. But I will still be treating for 24 weeks total.

As I know from my treatment with Sov Oly HVC not detected still is not the same as totally eradicated.

I was undetected at week 4 on treatment and at EOT but when I tested again 12 weeks after completing treatment the Virus was back in full force same number as before I treated in just 12 short weeks.

Best of luck to you with treatment may you make SVR

DisabledHepcat · « **Reply #10 on:** January 31, 2015, 02:53:05 am »

Lynn -- read (RT-PCR) the test you showed is a qualitative test..
Qualitative reverse transcription- polymerase chain reaction (RT-PCR) assays for HCV RNA are simpler than quantitative tests and sufficient for confirmation of the diagnosis of HCV infection.
http://www.hepatitiscentral.com/hcv/hepatitis/hcvdiag.html
Again, a quantitative test will ONLY show Detected above 16, the statement reads LESS THAN 15 DETECTED.
It does not say and cannot say LESS THAN 15 UNDETECTED because it cannot see below 15.

Lynn K · « **Reply #11 on:** January 31, 2015, 03:13:03 am »

And yet mine is a qualitative and says not detected it does not say "<15 not detected" it says "not detected"

so hopeful's test says exactly what the note says "Results less than the quantitative range of the assay will be reported as "HCV RNA detected, less than 15 IU/mL"."

While my test on 9/3 says HCV RNA RT-PCR, QT IU/mL 2422260

Hey I don't know what to tell you I am not a scientist or a lab technician I just am reading my lab report and sohopeful's reported result.

I have seen others post they had the <15 detected result and the next time tested it said HCV not detected.

I don't know what to say sohopeful's said ">15 detected" mine said "HCV not detected" that is all I know.

Hey I am a machinist working in a machine shop at night who reads to much about hep c that is all I got for you.

Best regards

Lynn K · « **Reply #12 on:** January 31, 2015, 03:19:01 am »

OK found this may help our discussion from the Mayo clinic

http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/83142

excerpt:

"Interpretation

This assay has a result range of 15 to 100,000,000 IU/mL (1.18 log to 8.00 log IU/mL) for quantification of hepatitis C virus (HCV) RNA in serum.

An "Undetected" result indicates that the HCV is absent in the patient’s serum specimen.

A result of "<15 IU/mL (<1.18 log IU/mL)" indicates that HCV RNA is detected, but the HCV RNA level present cannot be quantified accurately below this lower limit of quantification of this assay. When clinically indicated, follow-up testing with this assay is recommended in 1 to 2 months.

To assess response-guided therapy eligibility, an "Undetected" result is required, and a result of "<15 IU/mL mL (<1.18 log IU/mL)" should not be considered equivalent to an "Undetected" result."

DisabledHepcat · « **Reply #13 on:** January 31, 2015, 03:23:08 am »

A qualitative test does not have a number it is either DETECTED or NOT DETECTED
while a quantitative test will show a number above 15 or less than 15 detected.

Lynn K · « **Reply #14 on:** January 31, 2015, 03:32:06 am »

My test was called "HCV RNA BY RT-PCR, QUANT" copied straight from my report

did you read the Mayo clinic link?

Article title:
Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR (RT-PCR), Serum

again the excerpt

"An "Undetected" result indicates that the HCV is absent in the patient’s serum specimen.

A result of "<15 IU/mL (<1.18 log IU/mL)" indicates that HCV RNA is detected, but the HCV RNA level present cannot be quantified accurately below this lower limit of quantification of this assay."

That is all I know.

As I read this it says to me that the HCV RNA by PCR QUANT can report per the Mayo clinic link:
""An "Undetected" result indicates that the HCV is absent in the patient’s serum specimen." Like my result....

or it can report:
A result of "<15 IU/mL (<1.18 log IU/mL)" indicates that HCV RNA is detected, but the HCV RNA level present cannot be quantified accurately below this lower limit of quantification of this assay."

like sohopeful's result <15 detected

That is how I read this information

DisabledHepcat · « **Reply #15 on:** January 31, 2015, 03:35:27 am »

Whoever wrote that statement at the Mayo clinic is wrong.

Even your Qualitative test of Not detected does not mean you don't still have less than 5.3 IU/ML in your blood. You could have 1 - 5.2 IU/ML and that will grow again.
I'm going to get qualitative tested 3-6-12 months after I am so called undetected.

Lynn K · « **Reply #16 on:** January 31, 2015, 03:36:40 am »

also your link
http://www.hepatitiscentral.com/hcv/hepatitis/hcvdiag.html

looks like it could be a little old as it has this remark:

"At the moment, HCV genotyping should be considered a research tool and not a part of the diagnostic algorithm in clinical practice."

Which is not current as the genotype test is no longer considered to be solely a research tool

DisabledHepcat · « **Reply #17 on:** January 31, 2015, 03:39:57 am »

This looks like your test which is both quantitative and qualitative.

87522 Hepatitis C Viral RNA, Quantitative Real-Time PCR with Reflex to Qualitative TMA All indications listed for qualitative HCV RNA assay above
Establish baseline viral load
Predict response to antiviral therapy
Differentiate lack of therapeutic response from partial therapeutic response
Linear range: 15 - 100,000,000 IU/mL (if <15 IU/mL, reflex to TMA Qualitative assay

Lynn K · « **Reply #18 on:** January 31, 2015, 03:54:58 am »

Well I am not going to personally disagree with the Mayo clinic they all went to school longer than I and studied way more medicine than me as well. I cannot imagine an institution as prestigious as the Mayo clinic putting it's name on bad info but I guess it could happen. Again I just go by what I am reading.

I do totally agree the Qualitative test is more sensitive and that just because my HCV RNA by PCR QUANT reported HCV not detected I concure and said above that still does not mean the total eradication of the virus. If it did we would stop treatment at that point and obviously we do not.

I will be treating for 20 weeks after my not detected result. And as I said before I was similarly not detected on Sovladi and Olysio but yet still relapsed so obviously there were still some left.

They never said the virus was gone only that it could not be detected by the test science does have its limits and so do all medical tests.

No one ever said not detected means eradicated.

Undetected: 1. not perceived, noticed, or discovered

Eradicate: To completely do away with something, eliminate it, end its existence.

Only time after treatment is the proof when they don't reappear because they truly are gone. No one can say they are cured at EOT only at 12 weeks post at minimum or some say 24 weeks is a better test of cure

Speaking of a cure I hope all of us make it to permanent SVR and never have to deal with this virus again so hoping everyone beats the virus and we are all hep c free in 2015

Lynn K · « **Reply #19 on:** January 31, 2015, 04:00:44 am »

Perhaps you are correct I don't know. I don't see any ref to qualitative on the report.

It just says "HCV RNA BY RT-PCR, QUANT"

and the notes say:

"The quantitative range of the assay is 15 IU/mL to 100 million IU/mL
using COBAS(R) TaqMan(R) HCV test, v 2.0. The limit of detection (LOD)
and lower limit of quantification (LLOQ) for this assay is 15 IU/mL.
Results less than the quantitative range of the assay will be reported
as "HCV RNA detected, less than 15 IU/mL"."

I don't see any reference to qualitative but I suppose it could be.

Night it is late and I must sleep. Gotta get ready for the Super Bowl Sunday when the Seahawks win 2 in a row!

Go Hawks!

DisabledHepcat · « **Reply #20 on:** January 31, 2015, 04:10:56 am »

LOL New England wins by 17 at least, Harvoni was priced based on it WILL cure you and due to the ability for the drug to avoid liver transplants which are over $300,000.
I can't wait to see the insurance companies suing Gilead for people who relapse and need liver transplants. Also I believe HCV can hide in the bone marrow etc. Harvoni should be a daily prescription for life if people relapse, I mean HIV patients never stop taking their anti virals. I think this $1125 per pill will be $10 per pill when we find out we need it for life.

Lynn K · « **Reply #21 on:** January 31, 2015, 04:15:33 am »

Dunno I'm just a poor caveman lawyer.

Go puppy bowl woof!

DisabledHepcat · « **Reply #22 on:** January 31, 2015, 04:20:28 am »

Nice having a confusing conversation - How many bites to the center of an HCV Tootsie Pop liver cure ? The world may never know ! and who knows what's going on anyway?
Obviously not me or you - LOL

Hepcat =^..^=

Lynn K · « **Reply #23 on:** January 31, 2015, 04:23:16 am »

And really were all actually in the matrix anyway

kate0b1 · « **Reply #24 on:** January 31, 2015, 06:03:21 am »

@lynnk, i LOVE the puppy bowl

kate

anniemybaby · « **Reply #25 on:** January 31, 2015, 06:19:02 am »

Hepcat I love your comment with the tootsie pop lol you got me laughing at 6 am

ma snart · « **Reply #26 on:** January 31, 2015, 10:46:08 am »

Helen just got her Harvoni 8 week labs and viral load test results, shows 22 in the viral load,
Doctor doesn't think its a problem, says that why he has her on 24 week program.

Insert lab report
The virus values reported are obtained by comparing the patient’s value to a linear set of standards known as the Analytical Measurement Range (between 8.00 L (100000000 IU/mL) and 1.7 L (50 IU/mL). Virus can be detected at a value below 1.7 logs virus but the quantitation value may not be accurate. For example, a value of 10 L IU/mL may be detected (but the real value could be 8 or 12). This value even if it could be inaccurate will be reported because it suggests that some virus is present or it may be sequestered in the liver.
Component Results
Standard Range

Your Value
Hepatitis C Quantitation by PCR IU/mL <50 IU/mL 22
Hepatitis C Quantitation by PCR logIU/mL <1.70 logIU/mL 1.35

I talked with the labs Director of Genetics and he told me there is so much confusion that his lab will report even a single digit if DETECTED,
He will only report a >50 when UNDETECTED
He mentioned that this has been reported to all local doctors, and as these test are done at a large Hospital most of the specialist use them in our area.

This was Helens 8 week result and I too was sad that it was still Detected
She did have a ruptured appendix 3 weeks back that may have caused her body not to fight as well as it should have been, almost healed from the surgery now.
All of the other results were fantastic, she is making blood platelets like never before and ALT 11 AST 24.
I have tried to find if patients with cirrhosis have more difficulty ridding their bodies of virus or if the virus is more resistant in this case?

Lynn K · « **Reply #27 on:** January 31, 2015, 02:16:15 pm »

Hi Ma
Thanks for the additional info

Basically the discussion was about sohopeful's result and mine as reported on our RCV RNA by PCR QUANT test result

His was:
HCV RNA, Quantitative Real Time PCR <15 DETECTED.

This was my 4 week test result and what an undetected test result:
HCV RNA RT-PCR, QT HCV Not Detected

I understand mine does not mean eridicated completely only that it is below the tests ability to detect the virus but I think it is a different result than >15 detected that sohopeful received unless this is one of those different labs report results in different ways.

That is not what I got from the Mayo labs article. They specifically said those were two different results at least how I read it.

http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/83142

Article title:
Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR (RT-PCR), Serum

"An "Undetected" result indicates that the HCV is absent in the patient’s serum specimen.

A result of "<15 IU/mL (<1.18 log IU/mL)" indicates that HCV RNA is detected, but the HCV RNA level present cannot be quantified accurately below this lower limit of quantification of this assay."

Do you have any thoughts on this? Is my result of "HCV not detected" different than "HCV >15 detected"? My thinkng is that it is different. But also basically splitting hairs as I could still have a very small amount of the virus still circulating just below the tests ability to detect.

Have a great day

bridget · « **Reply #28 on:** February 01, 2015, 08:58:04 am »

Hi,
You wrote:
"Do you have any thoughts on this? Is my result of "HCV not detected" different than "HCV >15 detected"? My thinkng is that it is different. But also basically splitting hairs as I could still have a very small amount of the virus still circulating just below the tests ability to detect."

**For the sake of clarity, I'm guessing you meant "HCV<15 detected" as in "less than?"

Yes, I am sure you are right that there is a difference. The reason I say that is because my 6 week labs said "HCV not detected" but, my 8 week labs said "<15" but the 8 week labs did not say "not detected." So, the test showed an increase in the # of virus bits in my blood that pushed it above the undetected line but still <15 IU/mL.

Good luck to us all.

Lynn K · « **Reply #29 on:** February 01, 2015, 04:21:58 pm »

Hi Bridget

Yes that was my intent less than. I never had a result of "<15 detected" myself. I had a lot of virus or UND.

I thought some had said they had "<15 detected" and on their next test had the result HCV not detected so was thinking they are two different results.

Sounds like you are just bouncing along the bottom of detectability. I expect you next test should be not detected and holy you stay that way. Good luck.

Thanks for your input

ma snart · « **Reply #30 on:** February 01, 2015, 05:31:04 pm »

Like I have posted previously. Director of Genetics says a >50 at his hospital is only resulted when UNDETECTED, otherwise a value of 1-50 is posted.
Helen still showed a 22 at end of week 8 Not a <50 result.

The virus values reported are obtained by comparing the patient’s value to a linear set of standards known as the Analytical Measurement Range (between 8.00 L (100000000 IU/mL) and 1.7 L (50 IU/mL). Virus can be detected at a value below 1.7 logs virus but the quantitation value may not be accurate. For example, a value of 10 L IU/mL may be detected (but the real value could be 8 or 12). This value even if it could be inaccurate will be reported because it suggests that some virus is present or it may be sequestered in the liver.
Component Results
Standard Range

Your Value
Hepatitis C Quantitation by PCR IU/mL <50 IU/mL 22
Hepatitis C Quantitation by PCR logIU/mL <1.70 logIU/mL 1.35

I talked with the labs Director of Genetics and he told me there is so much confusion that his lab will report even a single digit if DETECTED,
He will only report a <50 when UNDETECTED
He mentioned that this has been reported to all local doctors, and as these test are done at a large Hospital most of the specialist use them in our area.

Lynn K · « **Reply #31 on:** February 01, 2015, 05:37:27 pm »

Hi Ma as was pointed out to me do you mean <50 less than 50; or >50 greater than 50?

I have heard different labs use different reporting standards adding to all our confusion my doctor used Lab Corp I suspect that is why the differing scales and reporting methods

ma snart · « **Reply #32 on:** February 01, 2015, 07:17:11 pm »

Yes <50 less than 50 sorry I have modified post.
Thanks
And yes I can see why there is so much confusion.

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