6 ms·

Roche CEO's says some Covid-19 antibody tests are a disaster

57 points by djsumdog 7y ago

subaru_shoe 7y ago
“Chief Executive Severin Schwan said on Wednesday as he prepares to launch the drugmaker’s own antibody test next month.” chevy calls fords new car garbage.
- omosubi 7y ago
  I came here to say this - how is this news?
- Renaud 7y ago
  But he still has a point. Pushing all manners of unreliable tests will makes matters worse for everyone. Any test will need a very high degree of reliability or you’ll end up with large numbers of people being quarantined for nothing or, worse, large numbers of people with the virus allowed to roam free as they believe they are not carrying it.
  - Spartan-S63 7y ago
    The other issue is that we don't know what concentration of antibodies is required for immunity. We know these things for other diseases, like influenza, chickenpox, etc. We have no point of reference, so we can only test for the presence of antibodies. I think antibody tests are still likely to be useful, especially in collecting data on the pervasiveness of the disease and getting information to find out what threshold immunity occurs at. The messaging around them is rife for misuse, though. Everyone is looking for a silver bullet, but all we can do right now is the long, slog of science to get to a place where it's truly safe to try to return to a semblance of normalcy.
  - Gibbon1 7y ago
    Worse is people thinking they are immune based on a false positive and then engaging risky behavior.
- refurb 7y ago
  Based on the false positive and false negative rates of some of the tests out there, he's not wrong. There were several tests rushed out the door. It's hard to make the right call when you can't trust the results of your test.
  - alexandercrohde 7y ago
    Uh great, then he should cite his own test's accuracy rates and the other tests' accuracy rates and let the data bear that out. Conveniently, he refuses to say how accurate his company's own tests are...
    - icarus_camp 7y ago
      Both my spouse and I had COVID. I say probably because we both showed the expected moderate symptoms and we both did the Roche swab test for COVID. I came back positive. My spouse, with the same symptoms and who sleeps beside me every night, came back negative. Doctor just shrugged his shoulders and said "Yeah, it seems like if you have mild or moderate symptoms, the tests are only about 60% accurate." and just worked on the assumption we both had COVID for his suggested response. Later on, we did a blood test at local university and we both came back with positive for the antibodies. So yeah Roche needs to address their own tire fire of a test at some point.
- ekianjo 7y ago
  That does not mean that chevy is always wrong about ford.
- TylerE 7y ago
  That's actually extraordinarily rare. Companies just say "ours is better". That doesn't get you sued in an expensive, drawn out libel case.
- Schweigi 7y ago
  Not in this case. My brother works for Roche and is involved in producing the tests. He told me that all tests, except the ones from Abbott, are very not accurate at this moment.
  - alexandercrohde 7y ago
    Meh, give us data or nothing. The secondhand (hearsay) of an anonymous internet identity is inadmissable in the court of my opinion.
    - Schweigi 7y ago
      Hearsay of an anonymous internet identity is the best you can get at this point in time. Once the tests are out in May there will be public available data.
jxramos 7y ago
Proportionality frequently seems to escape journalists, why be satisfied with reports being confined to the qualitative and non-quantified realm? Give us some background please. In this molecular diagnostics domain what are typical figures for sensitivity and specificity? FDA lays down requirements for such things right? Anyone know off-hand what percentages are required for a diagnostic testing product to be released? For these tests in question how far off from those marks are we exactly?
- DenisM 7y ago
  There is no "typical" I'm afraid. Whether a test is useful or not depends on error rates, priors, and application of the result. For example, consider this scenario: - Virus has R0 of 2.5 - the test for the current infection (i.e. not antibody) is cheap and abundant - the test has 20% false positives - the test has 20% false negatives - Application: test every single person and confine everyone who tested positive to their homes, releasing the rest. Repeat weekly. Take no other action. Result #1: 20% of the population are in isolation. 20% of your economy is stalled, rather than 100%. Result #2: 1 in 5 infected will go undetected. Still 4 out of 5 are isolated, reducing the number of infected out there by a factor of 5, therefore your R0 drops from 2.5 to 0.5 The number of infected people on the street gets cut in half every week. Epidemic fizzles out. So even low-precision tests are useful. What is useless is tests that do not have a reliable metric for false positive / negative. Which is what many of the AB tests are.
  - perl4ever 7y ago
    "Result #1: 20% of the population are in isolation. 20% of your economy is stalled, rather than 100%." This bugs me, because in this hypothetical, you're implying something as a point of comparison which is nothing like reality. 100% of the population is not in isolation - the only people who are in isolation are those who have had such severe symptoms they've been tested and it came back positive, or they're really obviously linked to such a person. And obviously 100% of the economy is not stalled; it may not be precisely clear what the impact is so far, but people are talking about single digit GDP percentage point declines. If you frame that as the worst economic news since the great recession, or put it in context with the job losses, it's pretty bad, but it clearly could be ten times worse and it's not. I get that maybe you meant it as just an example and specifics aren't important to your point about statistics, but I feel like I've read similar posts to yours that kind of get the nonsensical scenario out there, that we've shut down "100%" to where people kind of get used to it even though it's not reality.
joezydeco 7y ago
So do we have any data showing that the presence of antibodies equals immunity? What exactly is the test telling us as of today?
- williamstein 7y ago
  Antibody tests also help estimate how many people have been exposed to sar-cov-2, which helps in making more accurate epidemiological models...
mynegation 7y ago
So how statistically independent is the error between serological tests? If we make 5 tests on the same blood sample and go with 3 or more out of 5 rule, would that help with FP and TP?
gumby 7y ago
I agree, the people who want “the red tape eliminated — lives are at stake” are nuts. Garbage data is garbage data and getting it sooner doesn’t help. False negatives can cause someone contagious or sick to go out and infect others; false positives can cause unnecessary treatment and take up hospital resources that should have been spent on actual patients.
- viggity 7y ago
  From what I gather a false positive for an antigen rtPCR is essentially impossible. The primers are extremely specific and can't find something that isn't there. A false positive for an antibody test is unlikely to take up hospital resources. They admit people to the hospital for symptoms like dyspnea/hypoxia. Not because the patient tested positive on either the antibody or antigen test. The danger in a false positive for an antibody test IgG or IgM, means gives the patient a false sense of security that they've already gotten the virus and are thus immune in the short to medium future.
  - logicallee 7y ago
    >a false positive for an antigen rtPCR is essentially impossiblee. The primers are extremely specific and can't find something that isn't there. I read somewhere that among the reasons for a false positive would be cross-contamination among samples. Just because the primers find something in the sample, doesn't mean that that something isn't in fact merely a bit of cross-contamination from another, true positive, sample.
    - xscott 7y ago
      I was watching this video earlier tonight: https://youtu.be/Vat-PKdQ13A?t=30 https://youtu.be/Vat-PKdQ13A?t=30 That looked like some really sloppy lab technique, and I hope that's not how it is really done in practice. If real tests are done by hand like this, with distractions, open air, and no mask on the technicians, it's easy to imagine false positives.
  - tinus_hn 7y ago

57 points by djsumdog 7y ago

“Chief Executive Severin Schwan said on Wednesday as he prepares to launch the drugmaker’s own antibody test next month.” chevy calls fords new car garbage.

omosubi 7y ago
I came here to say this - how is this news?
Renaud 7y ago
But he still has a point. Pushing all manners of unreliable tests will makes matters worse for everyone. Any test will need a very high degree of reliability or you’ll end up with large numbers of people being quarantined for nothing or, worse, large numbers of people with the virus allowed to roam free as they believe they are not carrying it.
- Spartan-S63 7y ago
  The other issue is that we don't know what concentration of antibodies is required for immunity. We know these things for other diseases, like influenza, chickenpox, etc. We have no point of reference, so we can only test for the presence of antibodies. I think antibody tests are still likely to be useful, especially in collecting data on the pervasiveness of the disease and getting information to find out what threshold immunity occurs at. The messaging around them is rife for misuse, though. Everyone is looking for a silver bullet, but all we can do right now is the long, slog of science to get to a place where it's truly safe to try to return to a semblance of normalcy.
- Gibbon1 7y ago
  Worse is people thinking they are immune based on a false positive and then engaging risky behavior.
refurb 7y ago
Based on the false positive and false negative rates of some of the tests out there, he's not wrong. There were several tests rushed out the door. It's hard to make the right call when you can't trust the results of your test.
- alexandercrohde 7y ago
  Uh great, then he should cite his own test's accuracy rates and the other tests' accuracy rates and let the data bear that out. Conveniently, he refuses to say how accurate his company's own tests are...
  - icarus_camp 7y ago
    Both my spouse and I had COVID. I say probably because we both showed the expected moderate symptoms and we both did the Roche swab test for COVID. I came back positive. My spouse, with the same symptoms and who sleeps beside me every night, came back negative. Doctor just shrugged his shoulders and said "Yeah, it seems like if you have mild or moderate symptoms, the tests are only about 60% accurate." and just worked on the assumption we both had COVID for his suggested response. Later on, we did a blood test at local university and we both came back with positive for the antibodies. So yeah Roche needs to address their own tire fire of a test at some point.
ekianjo 7y ago
That does not mean that chevy is always wrong about ford.
TylerE 7y ago
That's actually extraordinarily rare. Companies just say "ours is better". That doesn't get you sued in an expensive, drawn out libel case.
Schweigi 7y ago
Not in this case. My brother works for Roche and is involved in producing the tests. He told me that all tests, except the ones from Abbott, are very not accurate at this moment.
- alexandercrohde 7y ago
  Meh, give us data or nothing. The secondhand (hearsay) of an anonymous internet identity is inadmissable in the court of my opinion.
  - Schweigi 7y ago
    Hearsay of an anonymous internet identity is the best you can get at this point in time. Once the tests are out in May there will be public available data.

jxramos 7y ago

Proportionality frequently seems to escape journalists, why be satisfied with reports being confined to the qualitative and non-quantified realm? Give us some background please. In this molecular diagnostics domain what are typical figures for sensitivity and specificity? FDA lays down requirements for such things right? Anyone know off-hand what percentages are required for a diagnostic testing product to be released? For these tests in question how far off from those marks are we exactly?

DenisM 7y ago
There is no "typical" I'm afraid. Whether a test is useful or not depends on error rates, priors, and application of the result. For example, consider this scenario: - Virus has R0 of 2.5 - the test for the current infection (i.e. not antibody) is cheap and abundant - the test has 20% false positives - the test has 20% false negatives - Application: test every single person and confine everyone who tested positive to their homes, releasing the rest. Repeat weekly. Take no other action. Result #1: 20% of the population are in isolation. 20% of your economy is stalled, rather than 100%. Result #2: 1 in 5 infected will go undetected. Still 4 out of 5 are isolated, reducing the number of infected out there by a factor of 5, therefore your R0 drops from 2.5 to 0.5 The number of infected people on the street gets cut in half every week. Epidemic fizzles out. So even low-precision tests are useful. What is useless is tests that do not have a reliable metric for false positive / negative. Which is what many of the AB tests are.
- perl4ever 7y ago
  "Result #1: 20% of the population are in isolation. 20% of your economy is stalled, rather than 100%." This bugs me, because in this hypothetical, you're implying something as a point of comparison which is nothing like reality. 100% of the population is not in isolation - the only people who are in isolation are those who have had such severe symptoms they've been tested and it came back positive, or they're really obviously linked to such a person. And obviously 100% of the economy is not stalled; it may not be precisely clear what the impact is so far, but people are talking about single digit GDP percentage point declines. If you frame that as the worst economic news since the great recession, or put it in context with the job losses, it's pretty bad, but it clearly could be ten times worse and it's not. I get that maybe you meant it as just an example and specifics aren't important to your point about statistics, but I feel like I've read similar posts to yours that kind of get the nonsensical scenario out there, that we've shut down "100%" to where people kind of get used to it even though it's not reality.

joezydeco 7y ago

So do we have any data showing that the presence of antibodies equals immunity? What exactly is the test telling us as of today?

williamstein 7y ago
Antibody tests also help estimate how many people have been exposed to sar-cov-2, which helps in making more accurate epidemiological models...

mynegation 7y ago

So how statistically independent is the error between serological tests? If we make 5 tests on the same blood sample and go with 3 or more out of 5 rule, would that help with FP and TP?

gumby 7y ago

I agree, the people who want “the red tape eliminated — lives are at stake” are nuts. Garbage data is garbage data and getting it sooner doesn’t help. False negatives can cause someone contagious or sick to go out and infect others; false positives can cause unnecessary treatment and take up hospital resources that should have been spent on actual patients.

viggity 7y ago
From what I gather a false positive for an antigen rtPCR is essentially impossible. The primers are extremely specific and can't find something that isn't there. A false positive for an antibody test is unlikely to take up hospital resources. They admit people to the hospital for symptoms like dyspnea/hypoxia. Not because the patient tested positive on either the antibody or antigen test. The danger in a false positive for an antibody test IgG or IgM, means gives the patient a false sense of security that they've already gotten the virus and are thus immune in the short to medium future.
- logicallee 7y ago
  >a false positive for an antigen rtPCR is essentially impossiblee. The primers are extremely specific and can't find something that isn't there. I read somewhere that among the reasons for a false positive would be cross-contamination among samples. Just because the primers find something in the sample, doesn't mean that that something isn't in fact merely a bit of cross-contamination from another, true positive, sample.
  - xscott 7y ago
    I was watching this video earlier tonight: https://youtu.be/Vat-PKdQ13A?t=30 https://youtu.be/Vat-PKdQ13A?t=30 That looked like some really sloppy lab technique, and I hope that's not how it is really done in practice. If real tests are done by hand like this, with distractions, open air, and no mask on the technicians, it's easy to imagine false positives.
- tinus_hn 7y ago