Dear Ms. Lucas:
Unfortunately, there is no specific CLIA standard that addresses the quantity
of positive/negative specimens that should be tested during the procedure
validation process. As stated in the regulation excerpt shown below (section
2), it is up to each laboratory to establish its own ‘performance
specifications’ for procedures that ate developed ‘in-house’, as nearly all IHC
procedures are.
42 CFR 493.1253 Standard: Establishment and verification of performance
specifications.
(a) Applicability. Laboratories are not required to verify or establish
performance specifications for any test system used by the laboratory before
April 24, 2003.
(b)
(1) Verification of performance specifications. Each laboratory that introduces
an unmodified, FDA-cleared or approved test system must do the following before
reporting patient test results:
(i) Demonstrate that it can obtain performance specifications comparable to
those established by the manufacturer for the following performance
characteristics:
(A) Accuracy.
(B) Precision.
(C) Reportable range of test results for the test system.
(ii) Verify that the manufacturer's reference intervals (normal values) are
appropriate for the laboratory's patient population.
(2) Establishment of performance specifications. Each laboratory that modifies
an FDA-cleared or approved test system, or introduces a test system not subject
to FDAclearance or approval (including methods developed in-house and
standardized methods such as text book procedures), or uses a test system in
which performance specifications are not provided by the manufacturer must,
before reporting patienttest results, establish for each test system the
performance specifications for the following performance characteristics, as
applicable:
(i) Accuracy.
(ii) Precision.
(iii) Analytical sensitivity.
(iv) Analytical specificity to include interfering substances.
(v) Reportable range of test results for the test system.
(vi) Reference intervals (normal values).
(vii) Any other performance characteristic required for test performance.
(3) Determination of calibration and control procedures. The laboratory must
determine the test system's calibration procedures and control procedures based
upon the performance specifications verified or established under paragraph
(b)(1) or (b)(2) of this section.
I hope you find this feedback useful. I’ve prepared a document that outlines
how a laboratory can comply with the standards and would be happy to share it
with you; simply send me a message and I will respond accordingly.
Best Wishes,
Joe Myers, M.S., CT/QIHC(ASCP)
--
Message: 2
Date: Tue, 2 Jun 2020 09:25:03 -0700
From: "Paula"
To:
Subject: [Histonet] IHC validations
Hello,
I see 10 positive and 10 negative cases for CAP guidelines, but what about for
CLIA? What is their guideline to validate an IHC antibody?
Thanks in advance,
Paula
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