How to report a hsv-2 false positive and supplemental test to the fda?

[Doctorssuck124]

Hello Terri,

I had a false positive IGG test at 1.1 through LabCorp with a positive supplemental test that they offer which is trash because my western blot results were negative for hsv-2. I have gotten cold sores for years so I know I have hsv-1 but I knew for a fact I have never been exposed to hsv-2 and this false positive supplemental test really pissed me off having my gyno thinking I have genital herpes when I don’t. HOW IS THIS LEGAL? Doctors are misdiagnosing patients because of quest and LabCorps inaccurate herpes tests. I would like to report this to the FDA if possible or I can email it to you and you report it if you want. Either way I want something done about this this is just infuriating that people are being misdiagnosed with a INCURABLE STD and LabCorp or quest are not referring these low positive hsv-2 igg tests for western blot instead using there stupid supplemental tests to profit for money. The FDA must do something about this to stop this. please let me know any information where I can report my supplemental false positive test for hsv-2 IGG. Thank you

Also please answer this question: do I get false positives for hsv-2 because I have a high index range for hsv-1 therefore causing a low positive for hsv-2? This has to be the only answer because I always tested negative for hsv-2 before I started getting cold sores in high school I am now 27. Please elaborate if this is the case the FDA should make quest and LabCorp disclose those to patients before they take there stupid IGG tests for herpes.

[Terri Warren]

There may well be some cross-reactivity because of your high HSV 1, yes.
The LabCorp supplemental test is terrible. I have now more than 40 patients who have had false-positive supplemental tests. I’m glad you are pissed off. If this happened to me, I would sue LabCorp. I’m just waiting for someone to do that. And report it to the FDA (although I already have, many, many times). In a paper just published online, the Quest test has a 57% false-positive rate, if I’m reading this correctly.
I can recommend a good lawyer who deals with herpes cases if you decide to pursue legal action. It is totally pissing me off.

Terri

[Random555]

Hello! I would also be interested if others are pursuing legal actions related to false positives and bad testing procedures. Cheers.

[Terri Warren]

I have not heard of it happening, no. But hope springs eternal!

Terri

[Doctorssuck124]

You Hello Terri, I cannot financially pursue legal action at the moment I just wanted some information on how to report it to the fda. This whole experience caused me a lot of emotional distress because now I know i can’t get tested for herpes Unless I get the western blot. How am I supposed to get tested in the future if I can’t rely on the commercially available igg tests for hsv-2? Getting the western blot was such a hassle. And my doctors had no idea what it was. What happens if I move out of the country how will i receive accurate herpes testing abroad? I don’t understand why the university of Washington is not advertising the western blot so doctors are aware of what’s going on with these igg tests and can order there patient a western blot. Why are doctors not aware about herpes false positives?
Question to your answer: I noticed that in your older posts back in 2016 you were telling people that you no longer believed cross reactivity with hsv-1 was causing false positives for hsv-2. But you are telling me that you do believe my high index value for hsv-1 is causing my hsv-2 false positive. What made you change your mind from 2016? Is there research on cross reactivity of hsv-1 causing false positives for hsv-2? If so can you send me the link. I just want to know why I used to test negative for hsv-2 on LabCorp and quest when my hsv-1 index value was low and now that my index value for hsv-1 is high 48.3 I always test 1.1 index for hsv-2 in LabCorp and quest igg tests and then doctors think I have genital herpes when I don’t. It’s very frustrating.

Question: why do some people with hsv-1 get false positives for hsv-2 on these igg tests but others don’t? I read in your older posts you also have hsv-1 cold sores have you ever had a false positive for hsv-2 due to cross reactivity from your hsv-1? This is all very confusing and doctors are not helpful at all. Why is LabCorp and quest not disclosing there false positive rates with there tests to patients?

[Terri Warren]

I have changed my thoughts about cross reactivity now, yes. I see quite a different picture in the past 3-4 years on this.
the western blot used to be used only for research purposes but with a push from patients, it became available to the public. Three virologists read each test – it is not mechanized which makes it unavailable for general use at this time.
The CDC is very clear about false positives in its STI treatment guidelines but most doc probably don’t read those, I’m afraid.
Good question about why LabCorp and Quest are not disclosing the possibility of false positives. It makes me so angry.

Terri

[Doctorssuck124]

Hello Terri, so then how am I supposed to go about herpes testing moving forward since I cannot rely on LabCorp or quests stupid igg tests? As a woman who gets chronic yeast infections a lot doctors always want to test you for stds when you have a itch down there. I don’t know what to tell doctors in the future if they ever want to test me for herpes again if I have any vaginal itch since they are so uninformed about false positives. Can you please let me know how to go about future herpes testing and doctors?

Also, why do some people with hsv-1 get false positives for hsv-2 but others don’t? I’v noticed also on these forums of some people who test in the 1.1-3.5 range getting negative supplementals from LabCorp and others getting positive supplementals like I did but are negative on the western blot. Why is this?

[Terri Warren]

This is just a reality for you. The IgG test is likely going to give you false positive results moving forward
If you get symptoms that concern you, that you worry might be herpes, you should be seen by a provider and have a swab test done of any concerning skin changes. For you, this is the way you will find out about a herpes infection. or by doing the western blot, which I know is expensive and inconvenient.

Some people have a protein in their blood that somehow trips the IgG test to give a false positive result. We don’t know what the protein is about and why some people have it and others don’t.

BTW a class action lawsuit about this supplemental test is being seriously considered now by a patient who is a lawyer. Will keep you all updated.

Terri

[Author]

Posts