EU 2017/746 changes EU IVD markets.
And, as reported before, this change is to the worse of traditional IVD producers like Bios GmbH Labordiagnostik. Bios lost trust in it´s EU markets.
So we are sad to say, we will terminate Bios by the end of April 2024. This means, like our production before, our IVD market supply ends in April 2024.
München, 28.02.2024
Kraut Rüben Bommel
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Our sales of positive controls are rising and rising ...
... and thus the disparity between this turnover and the sales of all our other IFA test components (especially slides). As this market trend seems to continue unabatedly, we at Bios need to rethink our business concept. EU 2017/746 makes it easier for our customers (end users) to switch to self-manufactured reagents (LDTs) and makes future market access in the EU more expensive for us and all other existing IVD manufacturers.
München, 19.01.2024
Bommel Kraut Rüben
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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 February 2024, we made the following additions/changes in section "Technical Information".
Section III. Informations and directions for use of Bios® products
B. Parameter specific Instructions for use (Long versions)
HH6tie Biognost® Human Herpes Virus Antibody Assay
Section V. Test characteristics
Sensitivity and Specifity data of the following tests were actualized:
Antibodies to Human Virus 6 Antigens
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.....
12.02.2024
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How to bring our goods safely to our customers these days.
From TNT/FedEx co-workers as well as from TNT website publications, contradictory information is received concerning possible transportation problems (delay, loss) due to prolonged strike of TNT workers in Germany.
Nevertheless. Of all our shipments sent out with TNT/FedEx since beginning of June just one did not reach destination. And this only happened, because laboratory personal refused to pick up their shipment in local TNT/FedEx premises.
But. TNT workers strike in Germany now is said to be continued until July 15th at least and also, that even further prolongation of this strike is possible. Obviously, no motivation to service customer´s need is left over in TNT’s personal. Bios started looking for alternatives:
I. Next door to Bios, we have an old fashioned „Deutsche Post“. They ship „per express“ all over Europe. Their service: we are informed about possible strike activities in some country prior to sending shipments out. Time needed by „Deutsche Post“ to deliver “per express” is 24 hours regularly and max. 48 hours.
This service is the same you/we pay for when shipping with TNT/FedEx.
Sending your orders out with Deutsche Post would be a quick and well-defined alternative. And Bios will be happy to carry the shipments next door in person.
II. We start talking to UPS.
UPS is willing to take Bios as new customer, but start shipping with UPS may be possible only some time (?) later. But midterm this could be the best alternative for the intermediate or for the future.
III. Customer organizes transportation with shipper of his/her choice.
Bios really would appreciate this. We have no problem with this option at all. But, please note, that in the past we saw problems with this solution, since transportation pricing in Germany is (much) higher than in most other EU countries and German workers of the shipper of your choice may refuse to work on your order, because pricing is defined by shipper´s pricing in your country. You have to make sure, your shipper takes this aspect into consideration when accepting your order. Also pick up times may be a problem: Bios only starts at 9 a.m. and leaves at 6 p.m. except Friday, when we leave at 5 p. m..
Please think about our alternatives. We should stay in contact on this topic. And to bring your orders to your premises next week, we suggest to use “Deutsche Post” next Monday.
München, July 1st 2022
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For our customers:
We like to draw your attention to the paragraphs below that are currently of special importance in the General Terms and Conditions of Bios GmbH Labordiagnostik.
§ 1 General provisions
Quotes, shipping and other services by Bios GmbH are provided exclusively on the basis of these terms and conditions of delivery and payment. Bios GmbH herewith objects to any other terms and conditions of business taken by the buyer as basis for a purchase order.
§ 6 Shipping, risk assumption, indemnity insurance
Place of fulfillment is the registered office of Bios GmbH in Munich. Shipping of goods is taking place at the consignee’s request, expense, and risk. If shipping is delayed on the buyer’s request or due to the buyer’s default, goods are stored on the buyer’s expense and risk. In such an event the ready for dispatch notice is equivalent to actual shipping. When goods are being shipped, risks are passing over to the buyer as soon as we have turned over the goods to the post office, delivery service or shipping carrier, not later however, when the goods are leaving our business premises, for example using our or a customer’s own means of transportation.
If damages occur during transit, Bios GmbH is not obligated to initiate on the customer’s behalf any claims for damages against the shipping carrier. However, the buyer is entitled to assignment of a potential claim for damages against the shipping carrier by Bios GmbH. Goods are not insured by Bios. Customers who would like to take out additional insurance beyond the scope of the legal guarantee are advised to take appropriate action in a timely manner.
Munich, June 2022
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Important to know: The shelf life stated on our IVDs only applies if the Bios storage and handling instructions are strictly followed.
At Bios our products are stored at the temperatures specified on the product label. Importantly, to prevent any permanent changes in the molecular water structure of our reagents that as, we take care that the cooling range in our refrigerators never falls below the critical temperature of 4°C as this could unpredictably reduce shelf life. Shipping procedures for products requiring cooling are optimized to minimize exposure to room temperature. During transit our well insulated transport boxes protect the products against dangerous temperature fluctuations up or down during hot summer as well as cold winter days.
We make sure that scheduled transit times are not exceeded and we let our customers know in case any such delay has occurred. However, here ends our responsibility for the quality and performance of our products in the customer’s laboratory. With the arrival of the product in the customer’s laboratory the customer takes over responsibility for the product. If a user, after we provided technical guidance, is still unable to work reliably and successfully with our product we refuse to continue supplying our products.
How can our customers ensure in their own laboratory that they make best use of the long storage life of our products which we have proven in long term test series?
First, keep yourself up-to-date with our method- and parameter-specific instructions for use (m- or pGI): https://www.bios-world.com/e/techinfo.php III. Information and directions for use of BIOS products
When receiving a parcel from Bios with refrigerated goods customers can readily recognize this on the blue “cold chain” sticker on the outside of the transport box:
Bios parcels labelled with this sticker should be unpacked immediately and the goods transferred to the appropriate storage in accordance with the temperature range specified on the product label.
Products specified for refrigerated storage must not be frozen under any circumstances - least of all repeatedly. Freezing would destroy not only the activity of substrate slides but also especially the activity of conjugate and control preparations. The level of activity loss largely depends on the extent of temperature stress with time. Sub-dividing reagents (such as cutting up substrate slides, transferring conjugate or positive control reagents as conveniently handled volumes into small plastic vials) may lead to reduced activity or even a complete loss of product activity. Instead, after arrival in the customer’s laboratory, IVDs must be promptly and without delay placed into storage at the specified temperature range and continuously maintained at that range. Users should regularly check to assure that correct storage conditions are actually maintained. If there is a breakdown of a fridge or a shift in the controlled temperature range, users are advised to either discard the affected products or perform a “lot performance validation”. Only if the titers of the Bios positive controls are 100% reproduced those lots may still be used.
When using the refrigerated reagents for the designated tests at room temperature, time periods at room temperature should be clearly defined and strictly followed. However, even when following these strict handling procedures, once the conjugate or control vial is opened the guaranteed shelf life specified on the label of each product lot is no longer applicable.
Even when customers carefully follow the handling instructions for Bios reagents there is no guaranty that the desired results will be obtained:
- If tests work out poorly or not at all in the customer’s laboratory when Bios reagents (IVD) are mixed with other reagents, Bios will be unable to help.
If customers do not solely use Bios reagents in their tests, any exchange of a test component, such as introducing a component from another manufacturer or from another reagent lot, may result in malfunction of the test as a whole. Similarly, reagents produced in the customer’s own laboratory may lead to problems.
Customers are free to order single test components from Bios which enables free combination of components. However, if there is a problem with test performance it is the responsibility of the customer to clear up whether sole use of Bios reagents can solve the problem. Bios cannot assume any warranty for reagent combinations chosen by the customer.
- Use of our products for other than the intended purposes forfeits product warranty
If customers use the Bios test combinations (test kits) or single Bios reagents in different ways than described in the Bios directions for use, Bios will not take any responsibility for the obtained results even though all reagents or whole test kits may have been sourced from Bios.
Our products are designed and suitable for the respectively indicated applications in a routine diagnostic function but not for use in research projects or other differing purposes. An exception is the use of our test systems for training of medical technicians. In such cases, however, Bios would like to establish close cooperation with the teaching staff involved and also would define the requirements for the qualification level of the teachers.
- It is hardly possible for us to define everything that possibly may reduce or terminate the shelf life of our IVD products – actually of any IVDs. Instead we urge customers to strictly follow our instructions how to handle our goods when they arrive at their premises and how to use our products in their laboratory as specified in the directions for use. In case there are any uncertainties or questions you may have, we invite you to contact us on bios@bios-world.com. In this way we are happy to listen to you and we will try our best to responsibly resolve your queries.
Munich, January 2022
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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
November 2020
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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.
Kraut 15.1.2019
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