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IntroAs a chronic Lyme patient myself I'm well aware of the devastating consequences when having undiagnosed Lyme disease for years.
Therefore I'm committed to trying to highlight, in my blogs, any wrong doing in the diagnoses and treatments of Lyme disease. In this case a unscientific Lyme/Borrelia home tick test, CarePlus, that could potentially give you a false security about the tick that bit you not having Lyme disease. This article was published frontpage on the website of the largest newspaper of the Netherlands and has now been translated in English. Why? Because the test will be for sale in America and Canada in the near future. And I really want to warn people about the test. But the best case scenario would be to have the test removed from all stores. |
If you can't make it, don't fake it: 'Home tick test provides false security'
I recently read an interview with the CEO of Tropicare and CarePlus, a company that offers home tick tests. The test is for sale for ten euros at shops such as Kruidvat, bol.com and Wehkamp, and CarePlus is now ready to take over North America.
The test enables you to test a tick for Borrelia - the bacterium that can cause Lyme – while relaxing on your own couch; it sounds fantastic and straightforward, but unfortunately, Lyme disease is not straightforward. There are hundreds of Borrelia strains and numerous types of cell shapes, which means that even with a blood test that costs thousands of euros, the disease cannot always be properly indicated. So how could a €10 home tick test be able to!?
Other filth
And aren't we forgetting something? The ever delightful co-infections for example? A tick might not carry the Borrelia bacterium, but it could still pass on dozens of other types of filth that can make you ill. CarePlus does not test for these and does not even warn about them.
Together with Lidewij, another Lyme patient, I started tracking down more information about the test and I was shocked by what I found. In this episode of Kassa, the test was cut to bits.
'The ticks that caused a red ring and moreover, that were in fact infected with the Borrelia bacterium according to research by RIVM, tested negative with the home test. Consequently, the sensitivity of the test, as calculated by RIVM, was 0%. These tests are consequently unreliable. Yet they are still available.'
At the end of 2014, CarePlus launched a new and, so they say, improved test. Its reliability was claimed to be 92.99%.
'False security'
Gert van Dijk, the president of the Dutch Association for Lyme patients, is of a different opinion. "The test provides a false sense of security. It convinces people that they are not infected and as a result, they do not pay attention to the symptoms anymore. There is no reason whatsoever to assume that the test is effective. It seems a waste of money to me."
I spent hours online searching for scientific studies that support the claim of 92.99% reliability and I could not find a single study. That is because there are not any.
In a direct conversation I had with the CEO of CarePlus, he admitted this. They do have a study that they conducted themselves, but they do not want this to be shared publicly. I eventually received it in my mailbox. The study is a joke and lacks any scientific basis. For instance, only 22 ticks had been examined. The CEO responded by saying: "I fully agree that the population is not optimal if you want to make meaningful scientific statements."
Critical questions
The Dutch Tick-Borne Diseases Foundation (STZ) recently wrote the following about the test: 'The tick test only provides a false sense of security. STZ believes that the sensitivity and specificity of the tick test has not been established in a scientifically sound manner.'
I subsequently sent an email to the Dutch national institute for public health and the environment (RIVM) and asked them whether they think the new test is effective and whether they acknowledge the 92.99% reliability. They replied as follows:
'At the time, CarePlus submitted a draft validation report of the new test to RIVM. We asked some critical questions and made suggestions for improvements. As far as RIVM is concerned, the validation was incomplete and the draft report did not demonstrate that the new test was indeed able to predict whether a person will get Lyme disease after a tick bite.Thereafter, CarePlus has not contacted RIVM nor indicated whether the comments and suggestions had been implemented. It is therefore not possible for us to indicate whether the new test is able to predict whether a person will develop Lyme after a tick bite.'
Smart thinking.
So how on earth is sale of this test allowed in the US? I discovered the answer in the interview with the CEO. Reading between the lines showed what the company already knows: the test will not pass the US health protection. But of course, they have found a solution for this.
It is not easy to enter the US market, you require approval from various authorities. For the tick test, CarePlus had to decide whether or not to register the product as a so-called medical device. This means that the test must meet specific safety, health, environmental and consumer protection requirements.The CEO decided against this. "Getting it certified by the FDA would require years of hard work and a lot of money," says the CEO. "We declare that this is not a medical device, because you do not test the person, you test the tick." Smart thinking.
Man up!
And that is how in the near future US stores will sell a test – that is already available in the Netherlands – that does not pan out and that has nothing to do with science, but that does profess to warn about a possible Lyme infection.
CarePlus: if you can't make it, don't fake it! It is all right, you are not the only ones who are unable to develop a useful test. But at least be honest. Man up, admit it and take the tick test off the market asap. This is not about torn toenails, but about a potentially life-changing disease.
Writer: Berdien Renes ( @BerdienRenes)
Publiced: Telegraaf Website
I recently read an interview with the CEO of Tropicare and CarePlus, a company that offers home tick tests. The test is for sale for ten euros at shops such as Kruidvat, bol.com and Wehkamp, and CarePlus is now ready to take over North America.
The test enables you to test a tick for Borrelia - the bacterium that can cause Lyme – while relaxing on your own couch; it sounds fantastic and straightforward, but unfortunately, Lyme disease is not straightforward. There are hundreds of Borrelia strains and numerous types of cell shapes, which means that even with a blood test that costs thousands of euros, the disease cannot always be properly indicated. So how could a €10 home tick test be able to!?
Other filth
And aren't we forgetting something? The ever delightful co-infections for example? A tick might not carry the Borrelia bacterium, but it could still pass on dozens of other types of filth that can make you ill. CarePlus does not test for these and does not even warn about them.
Together with Lidewij, another Lyme patient, I started tracking down more information about the test and I was shocked by what I found. In this episode of Kassa, the test was cut to bits.
'The ticks that caused a red ring and moreover, that were in fact infected with the Borrelia bacterium according to research by RIVM, tested negative with the home test. Consequently, the sensitivity of the test, as calculated by RIVM, was 0%. These tests are consequently unreliable. Yet they are still available.'
At the end of 2014, CarePlus launched a new and, so they say, improved test. Its reliability was claimed to be 92.99%.
'False security'
Gert van Dijk, the president of the Dutch Association for Lyme patients, is of a different opinion. "The test provides a false sense of security. It convinces people that they are not infected and as a result, they do not pay attention to the symptoms anymore. There is no reason whatsoever to assume that the test is effective. It seems a waste of money to me."
I spent hours online searching for scientific studies that support the claim of 92.99% reliability and I could not find a single study. That is because there are not any.
In a direct conversation I had with the CEO of CarePlus, he admitted this. They do have a study that they conducted themselves, but they do not want this to be shared publicly. I eventually received it in my mailbox. The study is a joke and lacks any scientific basis. For instance, only 22 ticks had been examined. The CEO responded by saying: "I fully agree that the population is not optimal if you want to make meaningful scientific statements."
Critical questions
The Dutch Tick-Borne Diseases Foundation (STZ) recently wrote the following about the test: 'The tick test only provides a false sense of security. STZ believes that the sensitivity and specificity of the tick test has not been established in a scientifically sound manner.'
I subsequently sent an email to the Dutch national institute for public health and the environment (RIVM) and asked them whether they think the new test is effective and whether they acknowledge the 92.99% reliability. They replied as follows:
'At the time, CarePlus submitted a draft validation report of the new test to RIVM. We asked some critical questions and made suggestions for improvements. As far as RIVM is concerned, the validation was incomplete and the draft report did not demonstrate that the new test was indeed able to predict whether a person will get Lyme disease after a tick bite.Thereafter, CarePlus has not contacted RIVM nor indicated whether the comments and suggestions had been implemented. It is therefore not possible for us to indicate whether the new test is able to predict whether a person will develop Lyme after a tick bite.'
Smart thinking.
So how on earth is sale of this test allowed in the US? I discovered the answer in the interview with the CEO. Reading between the lines showed what the company already knows: the test will not pass the US health protection. But of course, they have found a solution for this.
It is not easy to enter the US market, you require approval from various authorities. For the tick test, CarePlus had to decide whether or not to register the product as a so-called medical device. This means that the test must meet specific safety, health, environmental and consumer protection requirements.The CEO decided against this. "Getting it certified by the FDA would require years of hard work and a lot of money," says the CEO. "We declare that this is not a medical device, because you do not test the person, you test the tick." Smart thinking.
Man up!
And that is how in the near future US stores will sell a test – that is already available in the Netherlands – that does not pan out and that has nothing to do with science, but that does profess to warn about a possible Lyme infection.
CarePlus: if you can't make it, don't fake it! It is all right, you are not the only ones who are unable to develop a useful test. But at least be honest. Man up, admit it and take the tick test off the market asap. This is not about torn toenails, but about a potentially life-changing disease.
Writer: Berdien Renes ( @BerdienRenes)
Publiced: Telegraaf Website
