Re: [Histonet] Histonet Digest, Vol 220, Issue 8

[Tony Henwood (SCHN) via Histonet]

Hello Jayalakshmy,

iPassport is our digital quality management system. It is a commercial product 
that allows us to collect data, record audits, document Corrective Actions, 
manage controlled documents (eg manuals), expiry data and verification of 
antibodies, staff competencies and training and equipment maintenance reports 
etc in order to aid us in meeting the ISO 15189 standard for laboratory 
accreditation.

The “History” screen is available on the Bond automated immunostainer.

This is our policy for quality assurance of out-dated antibodies, so the 
mechanics are our department’s procedure. I did not try to make it generic (too 
little time to edit ☺ ).


Tony Henwood JP, MSc, BAppSc, GradDipSysAnalys, CT(ASC), FFSc(RCPA) | Principal 
Scientist; Adjunct Fellow, School of Medicine, University of Western Sydney; 
Visiting Lecturer, School of Life Sciences, Faculty of Science, University of 
Technology Sydney | Histopathology
t: (02) 9845 3306 | e: 
tony.henw...@health.nsw.gov.au | w: 
www.schn.health.nsw.gov.au
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Cnr Hawkesbury Road and Hainsworth Street, Westmead, NSW Australia
Locked Bag 4001, Westmead 2145, NSW Australia
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From: jayalakshmy p.s [mailto:psjayalaks...@gmail.com]
Sent: Friday, 18 March 2022 12:45 AM
To: Tony Henwood (SCHN) 
Subject: Re: [Histonet] Histonet Digest, Vol 220, Issue 8

Hello Henwood,
Thank you for the reply to my post with elaborate explanation and appropriate 
references. We doubted about the validity of using after expiry date. We keep 
onslide controls for every case. So with your suggestion we are confident of 
using it looking at the control. We, in developing country has not much finance 
to replenish the reagents past expiry date frequently when it is sparingly used.
Sorry to say that I didnt understand the words ipassport & history screen. Can 
you elaborate a little more about these terms?
Thanks & Regards
Jayalakshmy


On Thu, Mar 17, 2022, 6:48 AM Tony Henwood (SCHN) 
mailto:tony.henw...@health.nsw.gov.au>> wrote:
Hi Jayalakshmy,

This our policy at the Kid's hospital in Sydney:

Validation of Expired Antibodies
Usually when a new concentrated antibody is received it will have an expiry 
date of around 2 years from receipt but usually we can continue to use 
antibodies well past this expiry date.

If the antibody continues to stain control sections appropriately, with no loss 
of sensitivity and no increase in non-specific staining then its use should be 
continued. If positive control samples are deemed unsatisfactory, even if the 
antibody is within the manufacturer’s printed expiration date, evaluation of 
the clinical specimen is aborted and the test deemed invalid. The quality of 
the primary antibody is therefore not based on an expiration date, but rather 
on its performance on a case-by-case basis with appropriate positive and 
negative control samples (1).

Several authors have investigated whether the shelf-life of diagnostic 
antibodies was longer than the expiry date on the label. They found them to 
work perfectly on routine histology sections (1-4). Monoclonal antibodies 
originally supplied as culture supernatants or as ascites (neat or diluted), of 
all isotypes, as well as all of the polyclonal antibodies, produced 
satisfactory staining irrespective of their age. Notable exceptions were 
ammonium-precipitated, IgM or conjugated antibodies.

The policy at CHW is, when an antibody has reached past its expiry date, its 
control is tested to ensure that there has been no loss of sensitivity in the 
test. This is now controlled through iPassport, where a task is attached to the 
antibody requesting validation of control when the antibody is expired. This 
can be easily done by using the History Screen and looking for use of this 
antibody within the last two weeks. If results of control are acceptable, 
another task is instigated for 6 months hence.

For antibody concentrates that are received without an expiry date, a 
verification is scheduled 12 months after receipt of the antibody.

If an antibody fails to perform to expectations then a Corrective Action 
Request is instigated in iPassport and appropriate investigation is instituted.

References:
1. Savage, E. C., & DeYoung, B. R. (2010). Antibody Expiration in the Context 
of Resource Limitation What Is the Evidence Basis?. American journal of 
clinical pathology, 134(1), 60-64.
2. Balaton, A. J., Drachenberg, C. B., Rucker, C., 

Re: [Histonet] Stability Guarantee vs Expiration date

[Terri Braud via Histonet]

Richard's suggestion is the most sensible suggestion that I've seen in a while, 
however, it means less money for reagent manufacturers, so I doubt we will ever 
see it come to pass. - Terri
--

Message: 2
Date: Thu, 17 Mar 2022 13:45:44 +
From: "Cartun, Richard" 

Well stated Tony, and thank for all this useful information.  I am hopeful that 
we can get expiration dates overturned here in the United States.  In the past, 
I have recommended a "Stability Guarantee" date to replace the "Expiration 
Date".  After that date passes it would be the responsibility of the performing 
laboratory to validate that the antibody is still working properly.  And, as 
you pointed out, this is easily accomplished with the positive control which is 
run in parallel.  Laboratories cannot no longer afford to discard expensive 
reagents, especially those that are not being produced any longer.  Also, with 
the current staffing crisis in Histology/IHC laboratories and supply-chain 
issues we need to simplify our work environment.

Richard

Richard W. Cartun, MS, PhD
Director, Histology & The Martin M. Berman, MD
  Immunopathology/Morphologic Proteomics Laboratory
Assistant Director, Anatomic Pathology
Department of Pathology & Laboratory Medicine
Hartford Hospital
80 Seymour Street
Hartford, CT  06102
(860) 972-1596 Office
(860) 545-2204 (Fax)



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Re: [Histonet] Histonet Digest, Vol 220, Issue 8

[Cartun, Richard via Histonet]

Well stated Tony, and thank for all this useful information.  I am hopeful that 
we can get expiration dates overturned here in the United States.  In the past, 
I have recommended a "Stability Guarantee" date to replace the "Expiration 
Date".  After that date passes it would be the responsibility of the performing 
laboratory to validate that the antibody is still working properly.  And, as 
you pointed out, this is easily accomplished with the positive control which is 
run in parallel.  Laboratories cannot no longer afford to discard expensive 
reagents, especially those that are not being produced any longer.  Also, with 
the current staffing crisis in Histology/IHC laboratories and supply-chain 
issues we need to simplify our work environment.

Richard

Richard W. Cartun, MS, PhD
Director, Histology & The Martin M. Berman, MD
  Immunopathology/Morphologic Proteomics Laboratory
Assistant Director, Anatomic Pathology
Department of Pathology & Laboratory Medicine
Hartford Hospital
80 Seymour Street
Hartford, CT  06102
(860) 972-1596 Office
(860) 545-2204 (Fax)



-Original Message-
From: Tony Henwood (SCHN) via Histonet 
[mailto:histonet@lists.utsouthwestern.edu]
Sent: Wednesday, March 16, 2022 9:18 PM
To: jayalakshmy p.s
Cc: 'histonet@lists.utsouthwestern.edu'
Subject: Re: [Histonet] Histonet Digest, Vol 220, Issue 8

EXTERNAL email from Outside HHC! Do NOT open attachments or click links from 
unknown senders.

Hi Jayalakshmy,

This our policy at the Kid's hospital in Sydney:

Validation of Expired Antibodies
Usually when a new concentrated antibody is received it will have an expiry 
date of around 2 years from receipt but usually we can continue to use 
antibodies well past this expiry date.

If the antibody continues to stain control sections appropriately, with no loss 
of sensitivity and no increase in non-specific staining then its use should be 
continued. If positive control samples are deemed unsatisfactory, even if the 
antibody is within the manufacturer’s printed expiration date, evaluation of 
the clinical specimen is aborted and the test deemed invalid. The quality of 
the primary antibody is therefore not based on an expiration date, but rather 
on its performance on a case-by-case basis with appropriate positive and 
negative control samples (1).

Several authors have investigated whether the shelf-life of diagnostic 
antibodies was longer than the expiry date on the label. They found them to 
work perfectly on routine histology sections (1-4). Monoclonal antibodies 
originally supplied as culture supernatants or as ascites (neat or diluted), of 
all isotypes, as well as all of the polyclonal antibodies, produced 
satisfactory staining irrespective of their age. Notable exceptions were 
ammonium-precipitated, IgM or conjugated antibodies.

The policy at CHW is, when an antibody has reached past its expiry date, its 
control is tested to ensure that there has been no loss of sensitivity in the 
test. This is now controlled through iPassport, where a task is attached to the 
antibody requesting validation of control when the antibody is expired. This 
can be easily done by using the History Screen and looking for use of this 
antibody within the last two weeks. If results of control are acceptable, 
another task is instigated for 6 months hence.

For antibody concentrates that are received without an expiry date, a 
verification is scheduled 12 months after receipt of the antibody.

If an antibody fails to perform to expectations than a Corrective Action 
Request is instigated in iPassport and appropriate investigation is instituted.

References:
1. Savage, E. C., & DeYoung, B. R. (2010). Antibody Expiration in the Context 
of Resource Limitation What Is the Evidence Basis?. American journal of 
clinical pathology, 134(1), 60-64.
2. Balaton, A. J., Drachenberg, C. B., Rucker, C., Vaury, P., & Papadimitriou, 
J. C. (1999). Satisfactory performance of primary antibodies beyond 
manufacturers' recommended expiration dates. Applied Immunohistochemistry & 
Molecular Morphology, 7(3), 221.
3. Argentieri, M. C., Pilla, D., Vanzati, A., Lonardi, S., Facchetti, F., 
Doglioni, C., & Cattoretti, G. (2013). Antibodies are forever: a study using 
12-26‐year‐old expired antibodies. Histopathology, 63(6), 869-876.
4. Drachenberg, C. B., Papadimitriou, J. C., Balaton, A. J., & Vaury, P. 
(2001). The total test approach to standardization of immunohistochemistry. 
Archives of pathology & laboratory medicine, 125(4), 471-471.


Regards

Tony Henwood JP, MSc, BAppSc, GradDipSysAnalys, CT(ASC), FFSc(RCPA)
Principal Scientist, the Children’s Hospital at Westmead
Adjunct Fellow, School of Medicine, University of Western Sydney
Tel: 612 9845 3306
Fax: 612 9845 3318
Pathology Department
the children's hospital at westmead
Cnr Hawkesbury Road and Hainsworth Street, Westmead
Locked Bag 4001, Westmead NSW 2145, AUSTRALIA



-Original Message-
From: jayalakshmy p.s via Histonet