help with test results

[em787]

So, my boyfriend was just diagnosed with HCV and his Dr recommended treatment. My own results as follow, HCV Ag low reactive 1.76, HCV RNA by PCR <46 not detected. Doctor suggested that I do an HCV RNA by TMA test. Does anybody know the difference between PCR and TMA tests?

[hrsepwrguy]

Hepatitis C Viral RNA, Quantitative TMA

Clinical Use
• Confirm active hepatitis C virus (HCV) infection
• Document rapid virologic response (RVR)
• Guide duration of therapy
• Confirm resolution of infection (sustained virologic response, SVR)

This test is generally not appropriate for establishing baseline viral load or early virologic response at week 12 of treatment.

This quantitative transcription-mediated amplification (TMA)-based assay can be used to measure viral load (concentration of HCV RNA in plasma) at several steps during diagnosis and treatment. Its low limit of quantitation (5 IU/mL) makes this assay suitable for confirming active infection in individuals with reactive HCV antibody enzyme immunoassay (EIA) results. However, if the viral load is greater than the upper limit of quantitation (7,500 IU/mL), an assay with a broader linear range is necessary to establish baseline viral load prior to treatment.

http://www.questdiagnostics.com/testcenter/testguide.action?dc=TS_HCV_RNA_QuantTMA
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Hepatitis C Viral RNA, Quantitative, Real-Time PCR

Methodology
Real-Time Polymerase Chain Reaction (RT-PCR)

Reference Range(s)
HCV RNA, Quantitative, PCR <43 IU/mL
HCV RNA, Quantitative, PCR <1.63 LogIU/mL

Clinical Significance
Useful in monitoring therapy and disease progression. Reportable range is 43 to 69,000,000 IU/mL

http://www.questdiagnostics.com/testcenter/TestDetail.action?ntc=35645
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HCV RNA by PCR <46 not detected. Doctor suggested that I do an HCV RNA by TMA test

Hepatitis C, RNA, Quantitative, PCR

Question 2. What do these test results mean: “<43 Detected” or “<43 Not Detected”?

According to the reagent manufacturer, the lower limit of detection differs from the limit of quantification. The lowest viral load this assay can accurately quantify is 43 IU/mL, but the limit of detection is 7.1 IU/mL for genotype 1 viruses, and 10 IU/mL for viruses with all other genotypes. Therefore, we can qualitatively report detection even if the viral load is under 43 IU/mL (ie, <43 Detected). Thus, “7.1 or >10 IU/mL, but <43 IU/mL). A “<43 Not Detected” means the assay did not detect HCV RNA (ie, RNA <7.1 or <10 IU/mL).

You have already tested down to 7.1 IU/ml not detected (TMA tests down to 5 IU/ml) so I really dont see the need for more testing,  you do not have HCV.

Have a great day

[ceanothus]

Hrsepwrguy is right, I'm just seconding his opinion. Your PCR test gives a clear negative so there's no point in throwing more money and time away on another test. I hope his doctor also told you that HCV is not an STD and is only transmitted blood to blood.

[em787]

thanks for a detailed and helpful comment, I have been stressed so much since I tested positive for antibodies last month. I am a blood donor and last donation was in  October , 2012. Didn't have any problems then.
I am really hoping you are right, and I am negative. Will retest in 4-6 month to confirm.

[em787]

Dr. told me only 1% probability through sexual contact. 1% scares me nevertheless

[ceanothus]

I believe the current consensus is that the risk of sexual transmission in monogamous heterosexual couples is virtually nil. There are slightly increased risks in anal sex, or in any rough sex that involves bleeding and also if HIV is also present. There are also slight risks of transmission if people share toothbrushes, nail clippers or other implements that can occasionally cause bleeding. It may be prudent to practice safe sex anyway, but you really have very little risk with "normal" (maybe average is a better word) kinds of sexual relations. Many of us had normal, unprotected relations with spouses or partners for decades, with HCV but without being aware of it, and didn't infect our partners. My hepatologist tells me that precautions are unnecessary in monogamous heterosexual relationships, and I believe that is the standard of advice. I just don't want you to worry unnecessarily. Good luck to both of you!

[em787]

I am trying to stay calm which has been very difficult. I have been reading on Quest's site and the recommendations are if HCV RNA by PCR is "not detected" but one is tested positive for antibodies results should be confirmed by RIBA, but Quest stopped providing the test. There is also another test HCV RNA by TMA which is supposedly the most sensitive test out there. So, I may follow with it in few weeks.
So, while I am hopeful that don't have the virus. I worry about testing positive for antibodies, even though "low reactive 1.76."  My blood tests were  ok in October when I donated blood so, why would I suddenly test positive?

[copyman]

I like your doctors thinking. Test with the most sensitive test to put this thing to rest.
Even though your are negative with the <43 test the fact remains  your boyfriend is positive. As rare as it is there could have been some type of exposure, i.e. sharing razors, toothbrush, sex (really rare).

The best test out there is the Labcorp NGI HCV Ultraqual measuring down to    < 2

best of luck

[hrsepwrguy]

Hepatitis C: Part I. Routine Serologic Testing and Diagnosis

Diagnostic Tests

SEROLOGIC ASSAYS

The diagnosis of HCV infection can be made by detecting either anti-HCV or HCV RNA. Detection of anti-HCV is recommended for routine testing of asymptomatic persons and should include use of both enzyme immunoassay (EIA) and supplemental or confirmatory testing with an additional, more specific assay. Use of supplemental antibody testing (i.e., RIBA) for all positive anti-HCV results of EIA is preferred, particularly in settings where clinical services are not provided directly.
Supplemental anti-HCV testing confirms the presence of anti-HCV (i.e., eliminates false-positive antibody results), which indicates past or current infection, and can be performed on the same serum sample collected for the EIA (i.e., routine serology). Confirmation or exclusion of HCV infection in a person with indeterminate anti-HCV supplemental test results should be made on the basis of further laboratory testing, which might include repeating the anti-HCV test in two or more months or testing for HCV RNA and determining the ALT level.

http://www.aafp.org/afp/1999/0101/p79.html

The riba test will only tell you whether your EIA test is a false positive or if you contracted HCV and cleared the virus through your own immune system, it is a more specific HCV antibody test, you already have a <43 not detected HCV RNA by PCR and as I pointed out, with Quest it actually tests down to 7.1 or 10 IU/ml depending on genotype.

TMA test linear range is 5 - 7500 IU/ml

HCV RNA by PCR (RT-PCR) linear range is <43 - 69,000,000 IU/ml for quantification and 7.1 or 10 - 69,000,000 IU/ml for detection, so by using a TMA test you gain a whole 2 to 5 IU/ml for detection purposes, in which you already have a negative test result.

[em787]

I went ahead and got HCV PCR by TMA test just to be sure. The results as follow
HCV RNA, QN TMA <5 ( 5 IU/ml)
HCV RNA, QN , TMA < 0.70 (< 0.70 log IU/ml)

It does not say undetected though

antibody is still reactive 1.72

does this mean I don't have it, or have very little presence in my blood?

thanks,

[hrsepwrguy]

"does this mean I don't have it"

Yes, congrats

Have a great day

[em787]

thanks to everyone for all the responses and support, special thanks to  hrsepwrguy :)