Number: 2142

Title: VIDAS reagents, background noise and substrate errors

CONCERNED COUNTRIES: All
This INFO applies to: BOTH CLINICAL AND INDUSTRY

Catalog Profile: BD, BD3, BQ

Reference N°/ VIDAS Reagents Name : All
Lot/Serial: All
Expiry date: NA

Issue Date : June 3, 2014

Section A: Details

Dear colleagues,

Substrate errors on VIDAS® reagents remain a major concern in your everyday support activities.
In order to provide you with latest information available, please find here an updated version of the
INFO 1105: "Substrate Errors on VIDAS® reagents", originally published October, the 24th of 2011.

1. Product Description

These information are applicable to all VIDAS® strips.

2. Context

The VIDAS® substrate is one of the most sensitive reagent of the VIDAS® strip.
This makes the substrate background noise reading a very good indicator of strip quality and kit aging.

You may remind that for all VIDAS® parameters, the minimum background value authorized is 11 RFU, while the
maximum background value authorized is parameter dependent.
See list attached:

VIDAS
substrate_highest background limit_05_2014.pdf

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 At the beginning of each run, the VIDAS® instrument will check each strip for background noise to be within its
authorized range (minimum/maximum value).
This feature will ensure the product quality is controlled prior every run and until the total consumption or the
expiration of the kit. As a result, product quality is checked to be compliant with manufacturer specifications.

3. Substrate evolution and impacts on results

We recently performed a study with values gathered on several customers sites.

We have highlighted that:

• the substrate signal is closely linked to reagents storage conditions and reagents handling: bad practices will
cause faster substrate aging
• if the substrate aging is faster than expected, it will impact the accuracy in the low part of the calibration
curve, hence impact accuracy in low RFV values.

Depending if the customer respects strictly what is indicated in Instructions For Use (IFU) or not, we can have a very
different substrate evolution, as showed below:
Substrate Background Reading

Reading
Substrate Background Reading

BackgroundReading
SubstrateBackground
Substrate

Time Time
(each part corresponds to a different box of reagents) (each part corresponds to a different box of reagents)

Fig 1. A customer who store its reagent properly and Fig 2. A customer who withdrew the whole kit from
followed IFU ("[…] only remove the required reagents the fridge, each time he needed to run an assay, and
from the refrigerator […]") did not strictly follow instructions (e.g. let reagents on
the bench)
- We can see that, for each box, the substrate value is
slightly increasing during time - In this case the substrate value increases faster during
- The mean substrate value stays within its acceptance time
values - The mean value is higher
- Scattering is within its tolerable range (no dispersion) - Scattering is much more degraded and there is high
dispersion with a lot of "flyers"
- There is a higher variation in lower RFV values, which
may lead to a higher dispersion in low signal result

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 4. At which step VIDAS® substrate quality can be impacted ?

1. At bioMérieux facilities level ?

As part of Quality Control SOP, we are able to ensure the substrate value is compliant when VIDAS® reagents are
released.
As per detailed in our corporate procedure1, bioMérieux pays a real attention to shipping conditions to subsidiaries
or distributors' facilities, especially by respecting the temperature conditions described in the list of thermo-sensitive
products (LLDC# 000022).
This shipment procedure is duly controlled to ensure only properly transported products will reach your place.

Probability to have a damageable impact on substrate very unlikely

2. At local facilities level ?

Upon reception from bioMérieux general warehouse, it is subsidiaries or distributors responsibility1 to ensure
products are stored, handled and shipped to customer appropriately.
According to local transportation contract, each local bioMérieux representative must ensure transportation
conditions are suitable and maintained1.

Probability to have a damageable impact on substrate possible

3. At customer's level ?
Upon reception from the local subsidiary or distributor, it is the customer responsibility to ensure products are stored
and handled appropriately, according to IFU (see example below for VIDAS® TSH)

Probability to have a damageable impact on substrate likely

The warm up time may not be mandatory,

e.g. emergency assays or some Industry parameters,
please refer to package insert.

1
. Procedure LLDC#000008 " SUPPLY CHAIN CORPORATE GUIDELINE Focus on Customer Satisfaction”

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 5. Conclusion and substrate errors management

We advise you to remind your customers that all operational procedures, working procedures, environment
conditions, and maintenance procedures must be strictly applied.
These points, detailed in the VIDAS®, mini VIDAS® and VIDAS® 3 user manuals, in each VIDAS® reagents instructions
for use, are specified to ensure their systems work in compliance with manufacturer specifications and
performances.
Only informed people from subsidiaries and distributors, in touch with our customers, can educate and train them on
the proper reagents handling.
Our studies demonstrates that, if all these points are respected, the substrate RFU value never exceeds 250 RFU at
customer's site. As a consequence, please find below the way to deal with substrate errors:

If you have any additional question or doubt concerning this INFO in general, please do not hesitate to contact the
GCS through general email box :
gcs_immunomarcy@biomerieux.com

Section B: Contact Information

+ 1 919 620 33 99 + 33 4 78 87 20 80 @ gcs_immunomarcy@biomerieux.com gcs.biomerieux.fr

℡ www

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