Technical Information

Here you will find information on these topics:

The topics are clickable and lead you directly to the desired information.
    Trackability
  1. Conformity according to Medizinproduktegesetz (MPG)
  2. Occupational safety
  3. Information and directions for use of BIOS products
  4. Photo Gallery of Test results and important staff
  5. Test characteristics - Sensitivity and Specificity of assays of the Biognost® line
  6. Running Times, Longterm Tests
  7. Troubleshooting
 

 

Trackability

On the label of each Bios product the lot number is given. Also lot number(s) is (are) given on Bios delivery notes.

On ordering a kit, assembled from different components with different lots, you may receive on request an analysis certificate listing all these different lot numbers of the different kit components.

Lot numbers unequivocally relate to start of lot production, lots of various components included, other production conditions, QC data and storage data until delivery.

 

I. Conformity according to Medizinproduktegesetz (MPG)

Relation between product groups and Bios reagents. Relation between product groups and EDMS classification.

Download of conformity data for our autoantibody assays: Herunterladen

Download of conformity data for our bacteria assays: Herunterladen

Download of conformity data for our viruses assays: Herunterladen

Download of conformity data for our fungi, protozoae and parasites assays: Herunterladen

II. Occupational safety

All in vitro diagnostics available from Bios GmbH Labordiagnostik, München, are designed and manufactured in full compliance with Directive 98/79/EC on in vitro diagnostic medical devices. Our product lines Biognost®, Biosave®, Biosorb® and Diagnos® comprise liquid reagents containing sodium azide as a preservative, mostly in a concentration of 0.09%, and in a few products up to 0.1%. Sodium azide is rated as a “dangerous component”. Because the sodium azide level does not exceed 0.1% and our products do not contain any other “dangerous components”, our products are not classified as “dangerous product”.
In compliance with REACH regulation EC1907/2006, we put together a material safety data sheet (MSDS) on our products which we will supply on request, or which may be downloaded below. The information provided is based on the current regulatory state and current state of knowledge and makes no claim to be complete. Our MSDS describes our products with respect to the relevant safety regulations and does not represent a guarantee for any other product characteristics.
Bios GmbH Labordiagnostik excludes any liability for damages that may arise from handling of or contact with our products.

Download of the MSDS :    Herunterladen

 

III. Information and directions for use of BIOS products

A. Method Specific Instructions for Use (Short-version)

Our Instructions for Use have developed from uniform “precursors” and adapted as needed to changing regulatory requirements.
Because we supply laboratories throughout the world our Instructions for use are available in different languages. These instructions for Use describe how to prepare and perform each assay and how to evaluate the assay results. Although the Bios assays are all based on well-known and adequately established methods, we do suggest to perform each assay run in accordance with our Instructions for use. They are available in the following languages:

Language Identification code
German d
English e
Flemish/Dutch fl
French f
Greek g
Italian i
Polish pl
Portugues p
Slovene si
Spanish es
Hungarian u

On popular demand, our Bios short-version Instructions for Use are now available to our customers as downloads. In turn, our assay kits will now be delivered to you without the paper copy of the Instructions for Use. This means that you will no longer receive the tri-lingual version of our Instructions for Use that you used to find in each supplied assay kit. The online version is available as monolingual document only. Please let us know if this causes any problems for you.


LfdNr ArtNr Label d e fl f g i pl p si es u
  1 E0002ti Biognost® Detection of Antigens
by Direct and Indirect Immunfluorescence
x x   x x x x x   x x
  2 E0001ti Biognost® Detection of Antibodies
by Indirect Immunofluorescence
x x x x x x x x   x x
  3 A0001ti Biosave® Detection of Antibodies
by Latexagglutination
x x   x x x x x   x x
  4 A0002ti Biosave® Detection of Antigens
by Latexagglutination
x x   x x x o     x o
  5 S0001ti Biosorb® Absorbentsx x x x x x x x   x x
  6 D0001ti Diagnos® Antibody RID o o                 o

x = available; o = in revision; no entry = not available in language selected

 

B. Long-version Instructions for Use (parameter specific)

Here we provide the long-version Instructions for Use in English and German version as well as other useful data to our customers in a password protected data room.

=> Long-version Instructions for Use (parameter specific).

 

IV. Photo Gallery of Test results and important staff

=> Photo Gallery of Bios Flower Power and Bios personnel.

=> Photo Gallery of Test results: Fluorescence pattern and other picture of test results

V. Test characteristics - Sensitivity and Specificity of assays of the Biognost® line

What is the value of test results in a medical laboratory?

There is no difference between the importance of a negative and a positive result. Producers and distributors of assays for the medical laboratory can not take off  responsibility from appliers to determine selection concerning these assays for their own institute.

Test characteristics which can be verified may help selecting a test system. When increase in quantity of tests performed no longer guarantees success, improvement of quality of single test result could be the alternative.

Documents published here represent data available in the published context from the date of upload. Since quality assurance is elemental part of our business, Bios constantly prepares new data for assay sensitivity and specificity. Thus updates of our published data may vary test characteristics. Visitors of Biosite® should stop by routinely.

And now, how to get to the data of interest?

First choose product group, e.g. bacteria, next choose the parameter of interest, e.g. Bordetella pertussis IgM. If you choose the sensitivity button (you find our Bios emblem on all these buttons) underlying document shows all actual (see publication date) sensitivity data characterizing our Biognost® Bordetella pertussis IgM assay. Want to see other data, please first close document by clicking on the “x” of this tab.

 

Parameter Sensitivity Specificity
Antibodies to basal membrane of the skin (ASA BM) Herunterladen Herunterladen
Antbodies to intercellular substance of the skin (ASA ICS) Herunterladen Herunterladen
IgG Antbodies to transitionel epithelium at paraneoplastic pemphigus Herunterladen Herunterladen
Anti-mitochondrial antibodies (AMA) Herunterladen Herunterladen
Anti-neutrophil cytoplasmic antibodies, cytoplasmic pattern (C-ANCA) Herunterladen Herunterladen
Anti-neutrophil cytoplasmic antibodies, perinuclear pattern (P-ANCA) Herunterladen Herunterladen
Anti-neutrophil cytoplasmic antibodies, atypical pattern (X-ANCA) Herunterladen Herunterladen
Anti-smooth muscle antibodies (ASMA) Herunterladen Herunterladen
IgA antibodies to endomysium (IgA EmA) Herunterladen Herunterladen
Antibodies to glomerular basal membrane (GBM) Herunterladen Herunterladen
Antibodies to islet cells of pancreas (ICA) Herunterladen Herunterladen
Antibodies to native double stranded DNA (nDNA) Herunterladen Herunterladen
Antibodies to adrenal cortex (AAA) Herunterladen Herunterladen
Antibodies to striated muscle antigens (SkmA) Herunterladen Herunterladen
Antibodies to ovary and testicle Herunterladen Herunterladen
Antibodies against pituitary gland Herunterladen Herunterladen
Parameter Sensitivity Specificity
Bartonella henselae IgG Herunterladen Herunterladen
Bartonella henselae IgM Herunterladen Herunterladen
Bartonella quintana IgG Herunterladen Herunterladen
Bartonella quintana IgM in revision Herunterladen
Bordetella parapertussis IgG Herunterladen Herunterladen
Bordetella parapertussis IgM Herunterladen Herunterladen
Bordetella pertussis IgG Herunterladen Herunterladen
Bordetella pertussis IgM Herunterladen Herunterladen
Bordetella pertussis IgA Herunterladen Herunterladen
Borrelia burgdorferi IgG Herunterladen Herunterladen
Borrelia burgdorferi IgM Herunterladen Herunterladen
Borrelia burgdorferi IgA Herunterladen Herunterladen
Coxiella burnetii Phase I IgG Herunterladen Herunterladen
Coxiella burnetii Phase I IgM Herunterladen Herunterladen
Coxiella burnetii Phase II IgG Herunterladen Herunterladen
Coxiella burnetii Phase II IgM Herunterladen Herunterladen
Haemophilus influenzae Typ B IgG Herunterladen Herunterladen
Haemophilus influenzae Typ B IgA Herunterladen Herunterladen
Helicobacter pylori IgG Herunterladen Herunterladen
Helicobacter pylori IgA Herunterladen Herunterladen
Legionella pneumophila SG 1-6 antibodies Herunterladen Herunterladen
Legionella pneumophila SG 1-6 IgM Herunterladen Herunterladen
Leptospira interrogans IgG Herunterladen Herunterladen
Leptospira interrogans IgM Herunterladen Herunterladen
Listeria monocytogenes Typ 1 IgG Herunterladen Herunterladen
Listeria monocytogenes Typ 1 IgM Herunterladen Herunterladen
Listeria monocytogenes Typ 4b IgG Herunterladen Herunterladen
Listeria monocytogenes Typ 4b IgM Herunterladen Herunterladen
Mycoplasma pneumoniae IgG Herunterladen Herunterladen
Mycoplasma pneumoniae IgM Herunterladen Herunterladen
Mycoplasma pneumoniae IgA Herunterladen Herunterladen
Rickettsia conorii IgG in revision in revision
Rickettsia conorii IgM in revision in revision
Yersinia enterocolitica IgG Herunterladen Herunterladen
Yersinia enterocolitica IgA Herunterladen Herunterladen
Parameter Sensitivity Specificity
Candida albicans IgG Herunterladen Herunterladen
Candida albicans IgM Herunterladen Herunterladen
Candida albicans IgA Herunterladen Herunterladen
Echinococcus granulosus antibodies Herunterladen Herunterladen
Entamoeba histolytica IgG Herunterladen Herunterladen
Entamoeba histolytica IgM in revision in revision
Giardia lamblia IgG Herunterladen Herunterladen
Giardia lamblia IgM Herunterladen Herunterladen
Leishmania donovani IgG Herunterladen Herunterladen
Leishmania donovani IgM Herunterladen Herunterladen
Trichinella spiralis antibodies Herunterladen Herunterladen
Trypanosoma cruzi IgG*
*substrate T. bennetti and T. lewisi
Herunterladen Herunterladen
Trypanosoma cruzi IgM*
*substrate T. bennetti and T. lewisi
Herunterladen Herunterladen
Parameter Sensitivity Specificity
Adenovirus IgG Herunterladen Herunterladen
Adenovirus IgM Herunterladen Herunterladen
Adenovirus IgA Herunterladen Herunterladen
Coxsackievirus A9 IgG Herunterladen Herunterladen
Coxsackievirus A9 IgM Herunterladen Herunterladen
Coxsackievirus A24 IgG Herunterladen Herunterladen
Coxsackievirus A24 IgM in revision Herunterladen
Coxsackievirus B 1-6 IgG Herunterladen Herunterladen
Coxsackievirus B 1-6 IgM Herunterladen Herunterladen
EBV VCA IgG Herunterladen Herunterladen
EBV VCA IgM Herunterladen Herunterladen
EBV VCA IgA Herunterladen Herunterladen
EBNA Herunterladen Herunterladen
EBV EA diffus IgG Herunterladen Herunterladen
EBV EA restricted IgG Herunterladen Herunterladen
Echovirus IgG Herunterladen Herunterladen
Echovirus IgM in revision Herunterladen
HHV6 IgG Herunterladen Herunterladen
HHV6 IgM Herunterladen Herunterladen
HSV 1 IgG Herunterladen Herunterladen
HSV 1 IgM Herunterladen Herunterladen
HSV 2 IgG Herunterladen Herunterladen
HSV 2 IgM Herunterladen Herunterladen
Influenza Virus A IgG Herunterladen Herunterladen
Influenza Virus A IgM Herunterladen Herunterladen
Influenza Virus B IgG Herunterladen Herunterladen
Influenza Virus B IgM Herunterladen Herunterladen
Masernvirus IgG Herunterladen Herunterladen
Masernvirus IgM Herunterladen Herunterladen
Mumpsvirus IgG Herunterladen Herunterladen
Mumpsvirus IgM Herunterladen Herunterladen
Parainfluenzavirus Type 1 IgG Herunterladen Herunterladen
Parainfluenzavirus Type 1 IgM Herunterladen Herunterladen
Parainfluenzavirus Type 1 IgA Herunterladen Herunterladen
Parainfluenzavirus Type 2 IgG Herunterladen Herunterladen
Parainfluenzavirus Type 2 IgM Herunterladen Herunterladen
Parainfluenzavirus Type 3 IgG Herunterladen Herunterladen
Parainfluenzavirus Type 3 IgM Herunterladen Herunterladen
Parvovirus B19 IgG Herunterladen Herunterladen
Parvovirus B19 IgM Herunterladen Herunterladen
RSV IgG Herunterladen Herunterladen
RSV IgM Herunterladen Herunterladen
RSV IgA Herunterladen Herunterladen
Varizella Zoster Virus IgG Herunterladen Herunterladen
Varizella Zoster Virus IgM Herunterladen Herunterladen
Varizella Zoster Virus IgA Herunterladen Herunterladen

 

VI. Running Times, Longterm Tests

Longterm tests are quality controls, which are run within the running time (interval X), at the end of the running time (interval Y) and after the deterioration date (interval Z) of a lot. Successful LTs may be defined as successful quality controls for the remaining stock of a lot at the end of the running time, which thus converts into a new lot.

Here you'll find our => Long-time data.

 

VII. Troubleshooting

.under construction 21.12.2017

Lokalisation of errors: Herunterladen

Simple Consideration of errors: Herunterladen

Error No 1: Wells are empty: Herunterladen

Last modification: 15.1.2020

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Bios GmbH Labordiagnostik Hofmannstr. 7, D-81379 München Phone
0049/89/8988950
Fax
0049/89/89889540
bios@bios-world.com www.bios-world.com