Results - SPEC114220010015

DOE-SPEC-1142-2001

repeated. If a test is abnormal or borderline, then two duplicate repeat BeLPTs will be

requested. Usually these tests will be performed in two different laboratories or in one

laboratory utilizing two different sera. If at least two of the three BeLPTs are abnormal the

patient is deemed beryllium sensitized. Since the criteria for a single abnormal BeLPT is

based on an approximate false positive probability of 0.001, the chance of calling a person a

"sensitized responder" is very small (less than one in ten thousand). A person may be a

"sensitized responder" and not have CBD.

9.1.

The BeLPT shall be reported as unacceptable if any of the following criteria are NOT

met.

9.1.1. Background counts should be within the acceptable level for the counting

instrument (determined during the machine calibrations step performed as part

of the quality control procedures).

9.1.2. The control well counts should be at least 2 times higher than the background

counts (as a qualitative measure).

9.1.3. Mitogen-stimulated wells should clearly demonstrate lymphocyte proliferation

[standardized Ln(SI) greater than 3.0].

9.1.4. The internal variability for control wells or beryllium stimulated wells is

acceptable. The standard deviation of natural log transformed count data for

control wells should be less than 0.95, and for the Be treated wells it should be

less than 1.5 when 12 control wells are used and 4 beryllium stimulated wells

are used for each treatment group. These values are guidelines that are most

useful when there is no evidence for a beryllium response.

9.1.5. At least half of the standardized Ln(SI)s are greater than -3 (i.e., no strong

evidence of cell killing).

9.2.

A BeLPT shall be reported as an abnormal test if both of the following criteria are

met. (Appendix C contains three examples of the summary results illustrating a

normal test, an abnormal test, and a borderline test that requires further evaluation.)

9.2.1. The standardized maximum Ln(SI) is greater than 3.l.

9.2.2. At least two standardized Ln(SI)s are greater than 2.5 indicating a positive

response to beryllium.

9.2.3. A large positive value of the standardized maximum SI indicates a "biological

positive" test, i.e., it indicates by how many standard deviations this metric

exceeds the typical maximum response for normal individuals in that serum.

Two or more large standardized Ln(SI)s indicate a "statistically positive" test.

For the BAL-LPT, only 9.2.2. needs to be satisfied for an abnormal test.