Bios GmbH Labordiagnostik is a “pharmaceutical business”
Bios has been around for many years before the currently still applicable EU regulations for In-Vitro-Diagnostic Devices (EU IVDR) became effective in 2002. Before that, the IVD were regulated in Germany by the directives laid down in the Deutsche Arzneimittelgesetz (AMG). Until the EU IVDR was introduced, only Japan, USA and Germany had IVD regulations in place. No such regulations existed anywhere else in the world.
We at Bios considered the AMG as pleasantly precise with clear guidelines to follow in the production and distribution of IVD.
Therefore, when the EU IVDR came into effect, the legal requirements for Bios seemed if anything less restrictive than under the previously applicable AMG regulations. Nevertheless we registered us with all our trade goods ((traded products)) with the DIMDI (German Institute for Medical Documentation and Information) and we labeled all our goods in the national language of the respective EU country. The latter was a really useful requirement of the EU IVDR. Basically though we maintained the organization of our production and distribution, and especially our quality management as set up under the AMG regulations, notwithstanding the fact that we continually optimize our processes, ecological balance score, and stock-keeping. Earlier, parallel to the EU IVDR, there were also the EU Medical Products Law (MPG) and the TÜV (Technical Inspection Authority) Rheinland, a state-accredited Notified Body in accordance with the then current EU MPG. Unfortunately this official regulatory certifier did not notice that one of their customers, a French manufacturer of medical devices, was illegally using a highly dangerous industrial silicone for the production of breast implants (this is an in-vivo product!). Despite the large number of seriously affected woman, the TÜV Rheinland got away without too much trouble and throughout Europe without any legally imposed punishment.
As a consequence of this serious slip-up in regulatory control, we were blessed among other things with new revised EU regulations for In-Vitro-Diagnostic Devices (EU IVDR 2017/746) which are scheduled to come into effect in May 2022. We do not know whether TÜV Rheinland will be again a state-accredited Notified Body for the new Medical Products Law. For in-vitro diagnostic devices, however, it has been accredited again. It is hard to believe. For the whole of Europe there are currently still no more than a total of four accredited Notified Bodies published in NANDO (New Approach Notified and Designated Organisations). Three of those are based in Germany (besides the TÜV Rheinland, the DEKRA, and the TÜV Süd), and one in the Netherlands. For the whole of Europe. None in France, Spain, Italy, Poland or in any of the other European countries. How is that supposed to work? We consider it unlikely that, e.g., a Greek manufacturer of in-vitro diagnostic devices will be able to pay the German prices for registering his products with a German Notified Body. What did the EU, what did the individual EU countries do since 2017 to implement the transition to the new IVDR? Aren’t all European countries participating in the transition to the new IVD regulations? There is not much time left for getting things into place.
Bios is based in Munich and has tried for a considerable time to register with the TÜV Süd. For the time being this seems not possible. However, you can make an advance booking for being registered when possible. Possibly there may be charges for any such advance bookings. We still hesitate to make the advance booking. At least we managed to register for a TÜV seminar to be held in Leipzig coming September. Then at last we should see how the matter would be expected to progress.
The Unique Device Identification (UDI) for our products is coming along very nicely – our only comfort in our endeavours towards compliance with the new EU regulations for In-Vitro Diagnostic Devices. We already also registered with the new European data base EUDAMED although we don’t quite see the purpose of this data bank just yet. Our current feeling is that we may not be on time to meet all the requirements of the new EU IVDR 2017/746 by April next year. Luckily, however, there will be transitional arrangements until May 2025 for goods that have been on the Market for more than 3 years already. All our products comply with these requirements. And until May 2025, shall we say, we somehow or other will manage to comply with the new regulations.
And in fact we are and will remain - also in the times ahead of us - a pharmaceutical business.
We keep your Biosite® up to date
We implemented in Biosite® the section "News". Whatever is actually changed or added in our webite (within "Technical Data", regulation etc.) we publish here synchronously. Without searching around for relevant news on your end, you just can look into this rubric and find what you do not need or have been waiting for.
In the month of May 2021, we made the following additions/changes in section "Technical Information".
1. Section III. Informations and directions for use of Bios® products
B. Long-versions Instructions for Use(parameter specific)
Ebtie Biognost® Epstein Barr Virus antibodies assay
ASMAtie Biognost® SMA assay
2. Section V. Test charcteristics
Sensitivity and Specifity data of the following tests were actualized:
IgG, IgM and IgA antibodies to Epstein Barr Virus Capsid Antigen
IgG antibodies to Epstein Barr Virus Early Antigen "diffuse"
IgG antibodies to Epstein Barr Virus Early Antigen "restricted"
Antibodies to smooth muscle (SMA)
Cave: small changes in test inserts (without changing of the version number of the insert), adding sensitivity- or specificity data without resulting change in these two test characteristics etc. take place currently without any indication in this rubric.
And if you find major changes - no matter where on Biosite® - without publication in this rubric, please feel free to let us know. We might have forgotten.....
COVID-19: Not everyone who is tested positive can infect others.
Why do we hear so little about this issue? After all only those who are infectious should be invariably caught and sent into quarantine. In the current situation of steeply rising numbers of corona cases the pandemic could lose much of its scare if health authorities would focus on the criterion “probably infectious/highly likely not infectious”. The criteria for differentiating between those two states should be defined and regularly optimized as we gain more information from the steadily growing number of test results. To facilitate this important subdivision of positive Corona test results it may well be the better test concept if everyone who wanted to was allowed to be tested as often as desired, even in the absence of appropriate symptoms. However, the question is whether the responsible authorities would be able to cope with the additional work involved in classifying those who tested positive. Laboratory staff is already chronically stretched to the limit with the current work load. This is an unsatisfactory but currently unchangeable situation. Therefore, if the test concept described above does not provide us with the additional information about the infectious state of those tested positive we currently find the concept to test only those who show COVID-19-typical symptoms more convincing.
Kraut and Rüben
Testing, testing, testing
This was the official line in corona times for quite a long time. Now the conviction that in order to control the virus it would be best to test every one of our roughly 80 million inhabitants, preferably on a daily basis, is crumbling. This is probably not so much due to realizing that testing people who show no signs or symptoms may not provide conclusive results, but rather the fact that the mere number of tests would by far exceed the total of all available laboratory capacities. Also, as the embarrassing mishap in Bavaria has revealed recently, the logistics chain of sample acquisition from the test persons and distribution to the test laboratories is totally inadequate.
Now Hamburg’s proposal became accepted. Travelers entering the country will not be tested immediately at the border but 4 – 5 days after arrival. And meanwhile there is some hope that even when “Corona” is concerned, tests will only be done if justified on the basis of a qualified tentative diagnosis.
It seems to us that it was not a highly specialized virologist but rather a clinical pathologist (specialist in laboratory medicine) who was so persuasive in pushing these adjustments to testing policy. Chapeau.
End of August 2020
We are amazed.
In the member states of the European Union (EU),) the IVD Guidelines are still applicable for established in-vitro diagnostics (IVD). For newly released IVDs, however, a new IVD EU Regulation has been in force already for over a year. Under the new Regulation, substantially stricter requirements have to be met before a laboratory test may be CE labeled and released onto the market.
To the best of our knowledge, the “new” coronavirus, the SARS2 virus or how ever one wants to call it, that has been occupying us for the past 6 months, was first isolated towards the end of last year at the earliest. Then for a while it was more or less “forgotten” and was described in this country as a “far distant phenomenon”. Then, around February this year it suddenly was an omnipresent and highly dangerous contagion worldwide.
Since April this year the detection of the new coronavirus and detection of antibodies to this virus has become the most important means to maintain control over the spread of the virus. Principally, this is a reasonable approach. Accordingly, beginning around that time, manufacturers from within the EU as well as from various countries in Asia and North America have been offering us such tests for distribution by Bios. In this context, we are wondering how can it be that so many companies, some of them never heard of before, from many parts of the world, managed to get hold of the authentic antigen in the short time that was available for test development.
Furthermore, we are also wondering how these companies could possibly manage to fulfill all the requirements of the IVD Regulation in such a short time. To obtain product accreditation under the new Regulation, it is mandatory for IVD manufacturers to involve one of the few appointed Notified Bodies. In our experience, it takes substantially longer to develop a serological test for infectious diseases up to market introduction. We at Bios develop the specific requirements for our tests in collaboration with laboratories that have asked us to develop a specific test. For validating a new laboratory test before releasing it onto mankind, those who do not run their own research laboratory or university hospital facilities depend for test development on accepted reference collections from external sources and they need test samples characterized by qualified laboratories from a large number of different patients. How is it possible that all those numerous current providers of laboratory tests for detection of corona were able to get hold of the newly characterized corona virus antigen as well as the many characterized patient samples worldwide already before April/May this year? We are simply amazed.
New customers from countries outside the EU.
You are welcome. Lately we see growing interest and here are our basics for starting such cooperation.
- Start communication in writing (traditional mail, e-mail) and transmit your full address.
- Give basic information concerning your company (how old is your company, which markets do you supply etc. ) which enables Bios to get a realistic assessment.
- How did you come across Bios? If possible, name institutions and/or individuals bringing your attention to Bios. Did you cooperate with Bios before and if yes how?
- Which Bios products are you interested in?
- Shortly describe your actual product portfolio.
- What is your school/university education (scientific, commercial)
- Are you willing to come for a 2 – 3 days training in Bios prior to start business with us?
- Kindly note that first three orders of new customers from outside the EU must be prepaid.
This is how you will always keep up to date without wasting time!
Since the middle of January every page of our Biosite® is issued with a note showing the date of the last contents change on this page. This information enables users to promptly recognize where any changes relevant to them may have occurred. Especially any important changes on the technical pages are now more readily identifiable by users in the client’s laboratory.
Bios is changing to a new culture medium for growing protozoa
As we already let you know in our previous newsletter, we experienced poor growth rates in our amoeba cultures since the beginning of autumn last year. We began looking for the possible cause and comprehensively consulted several experts and suppliers. And we are pleased to report that we were successful. It is still too early to say that we now finally understand how to assure continuing supplies of our customers with amoeba-coated slides (Art. no. 50-1006). However, so far we were at least able to fulfill all incoming orders for amoeba slides – although partly with some delays. We have now changed the culture medium in which we grow the amoeba.
Unfortunately, our traditional supplier for culture media was of little help in solving our problem. Therefore as far as possible, we would like to make ourselves independent from this supplier. We are now planning to develop also new culture media for growing Crithidia, Lamblia, Leishmania, and Trypanosoma. While these changes will require some time we are determined to see them through in a systematic manner. Should the new growth conditions result in any changes of substrate appearance or activity we will inform you via our newsletter but also let you know individually.
Rüben, January 2020
Sample material for antibody detection with the immunofluorescence assay
Both serum and plasma are suitable sample materials for the immunofluorescence test. The recommended screening dilutions for serum/plasma samples you will find in our parameter-specific Instructions for Use. If, for example, a starting dilution of 1:4 is recommended, a plasma sample would be already diluted 4-fold. Nevertheless, assays with plasma samples can be unreliable due to interferences from the clotting system or from red blood cell lysis. The proteins involved may bind to the antigens attached on the test slide and thus prevent binding of the antibody under investigation. The outcome would be a false negative test result. Milky or reddish plasma samples, just like similarly affected serum samples, should first be purified. Clear plasma may be directly used for preparing serial dilutions.
Generally, liquor may also be used in these assays. If interested, please feel free to contact us (firstname.lastname@example.org). We will be pleased to answer your questions and provide any guidance you may require.
You can rely on topicality of Bios' website.
Only the actual versions of our test inserts (both method and parameter specific) are published on the Biosite®. The same is true for specificity as well as sensitivity data characterizing our test systems.
For us in Bios this is obvious. But it seems not to be the case in all internet publications.
How to organize your fridge better. Or, you will no more have to throw away expired lots.
Bios designs and develops its own data base surrounding together with teachers from Frauen Computer Schule, München (women´s IT hard and software school). Sometimes we add on a new feature seeming to be helpful not just for us but also for our customers completely on our own: idea and implementation.
Today we proudly present date of label printing on each label of each Bios product you purchase from now on. Please see examples below.
What does this mean for you? With 2 or 3 orders you get the same lot. With the new label printing date you can make sure the FiFo (first in, first out) rule is implemented. In other words: with this label printing date you can make sure you first use the oldest items of one and the same lot.
Kraut und Rüben 25.6.2019
You never saw Giardia lamblia thus wonderful on Biosite®.
So follow the path: Biosite® www.bios-world.com/e/techinfo.php
Various technical innovations result in crisp new pictures of our fluorescence patterns. So our old pictures are moved out and replaced stepwise by the new pictures.
We publish typical IFA fluorescence patters as an aid in IFA result interpretation when you are sitting at the microscope. And to some extent also just for fun.
Exchange of pictures of our complete IFA program from the old ones to the new ones will take time. We publish new fluorescence patterns after our internal testing activities and spare time.
But if you need one or the other pattern urgently, please let us know. Your wish will get preferential treatment.