[Histonet] Histonet Digest, Vol 220, Issue 8

Thu Mar 17 08:45:44 CDT 2022

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 at lists.utsouthwestern.edu]
Sent: Wednesday, March 16, 2022 9:18 PM
To: jayalakshmy p.s
Cc: 'histonet at 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 [mailto:histonet at lists.utsouthwestern.edu]
Sent: Thursday, 10 March 2022 1:27 PM
To: histonet at lists.utsouthwestern.edu
Subject: Re: [Histonet] Histonet Digest, Vol 220, Issue 8

Hello all, I would like to know whether Immunohistochemistry markers can be used after its expiry date(atleast in resource poor countries). If yes, for how much period of time and what is the criteria to look for?
Thanks and regards
Jayalakshmy

On Wed, Mar 9, 2022, 11:30 PM <histonet-request at lists.utsouthwestern.edu>
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> Date: Tue, 8 Mar 2022 12:17:13 -0600
> Subject: Re: [Histonet] Post message to Histonet Please post to
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> From: Greg Dobbin <greg.dobbin at gmail.com>
> To: Nancy.Schmitt at mercyhealth.com, histonet at lists.utsouthwestern.edu
> Cc:
> Bcc:
> Date: Tue, 8 Mar 2022 16:00:14 -0400
> Subject: Re: [Histonet] formalin in OR
> Hi Nancy,
> All routine specimens in our hospital are placed in formalin in the OR.
> Breast lumps and mastectomy specimens are sent up fresh so that they arrive
> STAT (to minimize cold ischemic times) and lymph nodes for lymphoma
> protocol are also sent up fresh. [*they actually send sentinel nodes up
> fresh too- it was just less confusing*]
>
> Diagnostic Imaging will place routine needle core biopsies directly in
> formalin (e.g needle cores of breast, prostate, non-lympoma lymph nodes and
> other misc. tissue masses). Lymph node cores for lymphoma protocol and
> renal cores are sent to the lab fresh, in a container on saline soaked
> Telfa pads.
>
> Endoscopy places all of their specimens directly in formalin. The derm
> clinic will place all routine skins directly into formalin but specimens
> destined for immunofluoresence are sent up to the lab fresh in a container
> on saline soaked Telfa pads. EBUS specimens are split between Cytology and
> Histology...the histo specimens go directly into formalin.
>
> Greg
>
> --
> *Greg Dobbin*
> 1205 Pleasant Grove Rd
> RR#2 York,
> PE      C0A 1P0
>
>
> *Everything in moderation...even moderation itself**!*
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> Date: Tue, 8 Mar 2022 14:19:11 -0600
> Subject: [Histonet] posting
> Please post:
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> Job open - Salt Lake City, UT - Pathology Lab Manager
> Relocation, sign on bonus available.
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> Please contact Chenoa Hardwick at chenoa at pathologywatch.com 972-351-0774
>
> *Chenoa Hardwick*
>
> VP of Laboratory Services
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> email: chenoa at pathologywatch.com <michael at pathologywatch.com>
>
> mobile: +1 972.351.0774
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> From: John Garratt <john.garratt at ciqc.ca>
> To: Nancy Schmitt <Nancy.Schmitt at mercyhealth.com>, "
> histonet at lists.utsouthwestern.edu" <histonet at lists.utsouthwestern.edu>
> Cc:
> Bcc:
> Date: Wed, 09 Mar 2022 01:28:25 +0000
> Subject: Re: [Histonet] formalin in OR
> I would not normally promote a product but I have seen the TissueSafe and
> SealSafe (Milestone) in use at a couple of hospitals for formalin
> management in the OR and in the lab and was most impressed.
>
> John
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> Sent from ProtonMail for iOS
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> On Tue, Mar 8, 2022 at 9:54 AM, Nancy Schmitt via Histonet <
> histonet at lists.utsouthwestern.edu> wrote:
>
> > Hello-
> > I would appreciate input on how you are getting formalin on to the
> specimens:
> >
> > * Is it done in OR
> > * Are specimens brough to pathology and add formalin there
> > * If so - does lab or OR add the formalin
> > * Other?
> > Are you Joint Commission?
> > Thank you!
> > Nancy Schmitt MLT, HT(ASCP)
> > Pathology Support Services
> > Dubuque, IA
> >
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