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.
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 July 2020, 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)
Evtie Biognost® Echovirus Screen IgG assay
2. Section V. Test charcteristics
Sensitivity and Specifity data of the following tests were actualized:
IgG and IgM antibodies to Echovirus
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.....
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 (email@example.com). We will be pleased to answer your questions and provide any guidance you may require.
Bios certainly does not work climate neutral.
Because we do not own but only lease our laboratory and office space, we have only little influence on such big issues like how we keep our rooms warm and where we obtain our electricity from (e.g. heat pump, photovoltaics). Too little to achieve a climate neutral status.
But we do make an effort where we can. For example, we sponsor wildflower strips. And from 2020 on we will change over to green electricity. Furthermore, also in 2020, we will acquire C02 certificates, enough that we may consider ourselves a climate neutral operating business.
In this context there is something else worth mentioning: Bios will not send immediate confirmation for each incoming order. This would be a waste of resources that we can avoid because we deliver without delay.
We dispatch the ordered goods every Monday and Wednesday. All orders received by noon on either of these days are dispatched on the same day. In other words, orders received on a Wednesday afternoon are dispatched on the following Monday. If this happens to be a public holiday, goods are dispatched on the next “dispatch day”, that is the following Wednesday.
You will hear from us only in case we cannot fully or only partly fulfill your order in the short-term. For both Bios and our customers, this means less administrative burden and less wasted materials and energy.
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.