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Erythrocyte Sedimentation Rate Journey Verifying A New Method For An Imperfect Test

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AJCP / Editorial

Erythrocyte Sedimentation Rate


Journey Verifying a New Method for an Imperfect Test
Jeannette Guarner, MD,1 Hannah K. Dolan, MT(ASCP),2 and Lisa Cole, MT(ASCP)2

From the 1Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA, and 2 Emory Healthcare, Atlanta, GA.

Am J Clin Pathol  October 2015;144:536-538

Downloaded from https://academic.oup.com/ajcp/article-abstract/144/4/536/1766140 by guest on 07 April 2019


DOI: 10.1309/AJCPQO81BGTKTVJJ

The rate of sedimentation of blood-formed elements in the method has to manipulate and pour blood into the
a predetermined amount of time, also known as the eryth- Westergren-Katz tube, the technique is considered to have
rocyte sedimentation rate (ESR), is used around the world a high biohazard risk. Thus, many companies have looked
by many clinicians in an effort to assess acute inflamma- into using methods that are better suited to modern clinical
tory response. ESR results have been incorporated into laboratories.
many practices and algorithms as a way to determine the One of the methods accelerates turnaround time to
presence of active inflammation.1-4 However, ESR is a less than 30 minutes by using the Boycott phenomenon.7
phenomenon that is not well understood since aggrega- For this method, the sample can be obtained directly (by
tion, precipitation, and packing of RBCs are facilitated by using the vacuum) or filled manually into shorter, rect-
many plasma proteins, including fibrinogen and immuno- angular, tapered tubes that are placed in an instrument
globulins, and affected by the amount and shape of RBCs.5 that maintains the temperature and holds them at an 18°
Because this phenomenon lacks specificity, clinical chem- angle to the vertical. The height of the RBCs is measured
ists and pathologists who direct clinical laboratories where using light transmission after the tube has been in place
ESR is measured believe it is a very imperfect test. In for 20 minutes, and a mathematical correction is applied
this editorial, we review how instrumentation in clinical to make the measurement comparable to the Westergren
laboratories has progressed to make it easier, faster, less ESR. Authors have found both favorable and unfavorable
hazardous, and more standardized to perform ESR, and comparisons of the shorter method to the standard refer-
we describe the challenges clinical laboratories encounter ence method.8,9 However, since we do not really know
when verifying fundamentally different technologies that what analytes are being measured with either technique,
measure the ESR phenomenon. why not use the method that offers advantages from the
The ESR testing method was developed by R. S. laboratory standpoint, including less manipulation of the
Fåhræus and A. V. A. Westergren. The original method specimen, smaller sample volume, and decreased turn-
was first described in 1921, and modifications of the around time?
original method have been selected as the reference stan- A second alternative sedimentation rate method that
dard by several agencies.6 In general, this method uses uses rheometry has also made it onto the market. Rheom-
blood that has been anticoagulated and diluted and then etry measures the flow and deformation of materials under
placed in the Westergren-Katz tube, which has to stand applied forces and can be determined on a microscale using
in a strictly vertical position in a rack for 1 hour at room optical techniques as the sample flows in a microcapillary.
temperature. The result is the measurement in millimeters When applying rheometry to determining the ESR, the
of the distance erythrocytes have fallen. This method is instrument uses anticoagulated blood that is sampled directly
manual and has many preanalytical and analytical factors from the tube from which it was drawn (usual tubes used
that can alter results. In addition, as the person performing for other purposes in the laboratory), and multiple optical

536 Am J Clin Pathol  2015;144:536-538 © American Society for Clinical Pathology


DOI: 10.1309/AJCPQO81BGTKTVJJ
AJCP / Editorial

140 laboratory values (WBC counts and C-reactive protein)


and clinical histories (rheumatologic/infectious disease or
120 malignancy). The review included those cases that would
have been within the normal range for one of the methods
Boycott Instrument

100
and elevated for the other. There were a total of 50 cases,
80
but review of the medical record was possible only in 45.
60 There were 25 female patients with discrepant results; in
36%, the method using rheometry could be considered to
40
correlate better according to the medical history. Of the 20
20 male patients, 55% were considered to correlate better with
the method using rheometry. The average difference was
0
20 mm in female patients and 16 mm in male patients, and

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0 20 40 60 80 100 120 140
there were six patients with a difference above 30 mm, with
Rheometry Instrument
one reaching 97 mm. Of these six patients, the method using
❚Figure 1❚ Comparison of 300 samples using the Boycott and rheometry was considered better in two patients. One patient
rheometry instruments. had a renal transplant and the WBC count was normal, and
the second had breast cancer with a normal WBC count
measurements are obtained as the blood flows in the micro- and C-reactive protein. The latter was the patient in whom
tube. The sedimentation curve obtained is transformed to the difference between the sedimentation rates was 97 mm.
comparable Westergren values. Several publications have In the other four patients, the sedimentation rate using the
presented good correlation of the results when comparing Boycott phenomenon was considered better; two patients
these instruments with the reference method.10-13 Advan- had active infections, one had a renal neoplasia, and the last
tages of instruments that use this technology include rapid patient had rheumatoid arthritis and scleroderma. In sum-
results, low imprecision, and performance that can be main- mary, although there are discordant cases when correlating
tained in blood stored for 24 hours. with other laboratory and clinical parameters, one method
The International Council for Standardization in Haema- does not seem to be better than the other.
tology recommends comparisons of new faster methods to We have had no clinical complaints after we imple-
the reference method.6 However, if your laboratory is already mented the ESR that uses rheometry. Technologists are
using one of the faster methods and you want to change to pleased with the new instruments since these are less labor
another method, the capability to compare to the reference intensive. However, the verification process was labor inten-
method will be limited. In the following, we describe the sur- sive, with comparison studies that needed a large amount of
prises encountered while verifying two rheometry instruments subjects and review of medical records of discrepant results,
to an instrument that uses the Boycott phenomenon: in addition to having to establish a new normal range for a
1. The precision studies for the low level had a coefficient specific population.
of variation (CV) between 25% and 28%, although the ESR In this era where health care systems are pressed for
results ranged from 2% to 5% in the rheometry instrument. better utilization, clinicians continue to use tests that were
The high level showed a CV that ranged between 11% and invented in the early 20th century and that measure phenom-
13%, with ESR values that ranged between 30% and 45%. ena that are obscure and have many variables, such as the
2. For the comparison, we used 300 patient samples that ESR. Verification of disparate methods for a phenomenon
ranged from a value of 1 to 130 with an intercept that was that is not due to one specific analyte can prove challenging
less than 1 and an almost perfect slope (1 and 1.08). How- and may require added clinical correlations in addition to the
ever, the dispersion was enormous ❚Figure 1❚. Taking the test usual verification steps.
as normal vs abnormal, 83% of samples were concordant
(28% in the normal range and 55% in the abnormal range)
and 17% discordant. References
3. We were able to verify the normal range for males
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© American Society for Clinical Pathology Am J Clin Pathol  2015;144:536-538 537


DOI: 10.1309/AJCPQO81BGTKTVJJ
Guarner et al / Verifying a New Method for ESR

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538 Am J Clin Pathol  2015;144:536-538 © American Society for Clinical Pathology


DOI: 10.1309/AJCPQO81BGTKTVJJ

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