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BioChek Why use the BioChek system ?


Which result is correct ? • The following 2 blockdiagrams show the results on 1 set of samples tested in 2 different laboratories. • The results are different. • Which result is correct ???


Which result is correct ? • The BioChek reference control (R4) will show which results is correct.


Why use the BioChek system • • • •

Reliable results Ease of use Service Other users


Reliable results Aids for quality control • Dessicant with color indicator • certificate of analysis(=COA) • optional additional control with known titervalue (prediluted)


QC of obtained results • Check quality of plates (color of dessicant) • check if negative and positive control are within specified range • check if value of BioChek reference control is in range and comparable with value on COA


Reliable results Dessicant with color indicator • Each plate is packed individually. A pouch containing dessicant is included. • In the case moisture leaks through pouch, the dessicant will absorb the moisture • when the dessicant is saturated, it wil turn from blue to bright pink color


Dessicant colors Possible colors of the dissicant in the BioChek kit ( this is the small package inside the plate package)

PLATES OK

Blue or Purple fresh kit

------------------------------------------------------------------------------------------------Plate quality possibly compromised

Pink:


Certificate of analysis Information provided on the COA: • Batch no + expiry date • batch no’s of all components • results at QC on the: negative-, positive and reference control


BioChek Crabethstraat 38-C, 2801 AN Gouda. Holland.

Tel: +31 182 582 592

Fax: +31 182 599 360

_____________________________________________________________________

Certificate of Analysis _____________________________________________________________________

Newcastle Disease Virus Antibody Test Kit Code: CK116 Lot No. FS3812 Expiry Date: 31st August 2003 ____________________________________________________________________ Kit Component Coated Plates Negative Control Positive Control Conjugate Reagent Substrate Buffer Reagent

Lot No. CH1610 CH1562 CH1621 CH1620 CH1554

Kit Component Substrate Tablets Stop Solution Sample Diluent Reagent Wash Buffer Powder

Lot No. CH1582 CH1576 CH1500 CH1474

_____________________________________________________________________ Quality Control Results

Mean Negative Control OD = 0.168 Mean Positive Control OD = 0.572 BioChek External Reference Control [RF04]

Antibody titre = 10726 (range 7500 – 12500)

Laboratory Temperature: 22oC

Date of test: 03.09.02

The above result was generated by performing the test in a temperature-controlled laboratory. If the temperature is below 22oC, lower OD values will be obtained. If the temperature is above 22oC, higher OD values will be obtained. Values obtained for test samples will be relative to the control values and the test will still be valid, provided, the mean negative control OD is below 0.3 and the difference between the mean negative control OD and the mean positive control OD is greater than 0.15 units.

_____________________________________________________________________ Material Safety Information The virus content of this product has been inactivated with β-propiolactone. __________________________________________________________________________________

The above information is correct and forms part of the Biochek Quality Assurance for NDV ELISA kit code CK116. Released by Q.A. – 03.09.02 ______________________ John Martin Quality Assurance.


Reliable results Reference control R4 • Prediluted sample with known titer range • same sample for IBD,IBV,NDV,REO,ART &AE • this will assure reproducability of quantitative results


Reference control ranges Test

Titer range

NDV IBV IBD REO AE ART

7500 - 12500 5000 - 9000 5500 - 9500 6500 - 10500 7000 - 11000 3750 - 6250

Above titer range is independent of: laboratory, kit batch, technician etc


Reliable results example • NDV assay performed in South Africa • NDV lot no: FS 3812


Highlight of certificate of analysis NDV FS 3812 Quality Control Results Mean Negative Control OD = 0.168

Mean Positive Control OD = 0.572

BioChek External Reference Control [RF04] Laboratory Temperature:

22 oC

Antibody titre10726 (range 7500 – 12500) Date of test:

03.09.02


Reliable results Example • RF04 result from field was: 10 051 • RF04 results on C.O.A. was: 10 726 • the range within which the field results should fall was: 7500 - 12 500 Conlusion: kit performed correctly and the results are valid


Reliable results Example The conclusion that the results are valid could not have been made when only based on the results of the negative and positive controls. This is the case for any ELISA kit giving quantitative results!


Reliable results control tracking The BioChek software has a report plotting the values of R4 on the Y-axis against the Batch number on the X-axis. Lab manager can easily check how good the lab is operating (see next slide)


Ease of use • Visual setup of software. No need for extensive training • software in many languages • comprehensive reporting system • same test procedure most kits


Service • • • • •

Regular visit’s to users training on laboratory technique training on application of obtained results training on interpretation of results Training can be done at our facility in Holland or locally at the customers site


BioChek service On site training


BioChek users • Customers in Europe, South America, USA, Middle East, Far East, Africa. • When asked most customers use BioChek because of excellent service and ease of use of the software. • Customers continue to use BioChek for the same reasons + the quality of the results


BioChek Users • We are very proud having among our large customer base the following customers; • Aviagen, Intervet, Cargill, Rainbow farms, Lohmann, CVL, and many other users. • Growth of BioChek in 2002 was 35% compared tot 2001


WHY BIOCHEK