Method of analyzing medical specimens with improved length of analytical run determination

• US 5,633,166 A
• Filed: 01/19/1995
• Issued: 05/27/1997
• Est. Priority Date: 01/19/1995
• Status: Expired due to Fees

• Current Assignee: Bio-Rad Laboratories Incorporated
• Original Assignee: MDS Health Group Limited
• Inventors: Mountain, Paul, Westgard, James O.
• Primary Examiner(s): Hutzell, Paula K.
• Assistant Examiner(s): FREED, RACHEL
• Application Number:
  US08/374,917
• Time in Patent Office: 859 Days
• Field of Search: 436/8, 436/12-16, 436/19
• US Class Current: 436/8
• CPC Class Codes: G01N 33/50 Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/102499 Blood gas standard or control
• CPC Class Codes: Y10T 436/103332 Bilirubin or uric acid standard or control
• CPC Class Codes: Y10T 436/104165 Lipid, cholesterol, or triglyceride standard or control
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control
• CPC Class Codes: Y10T 436/105831 Protein or peptide standard or control [e.g., hemoglobin, etc.]
• CPC Class Codes: Y10T 436/106664 Blood serum or blood plasma standard or control
• CPC Class Codes: Y10T 436/109163 Inorganic standards or controls

Abstract

In high volume laboratory analysis of patient medical specimens, control materials are inserted at periodical intervals (e.g. once per eight hours) and analyzed. If the results of the analysis deviate from the mean according to statistical rules, the run of analyses prior to the insertion of control materials has in the past been rejected, often causing a substantial loss of results because the control materials were not inserted sufficiently frequently. According to the invention the patient mean of a test is determined, and when the mean deviates from the predetermined mean by more than a selected amount, this determination is used, not to reject the run, but rather to trigger insertion and analysis of control materials. If the analysis of control materials shows that the run is in control, the analyses made prior thereto are reported and the run is resumed. If the control material analysis shows that the run is out of control, then the prior analyses are rejected.

Claims

1. A method of controlling analyzing patient medical specimens in an analytical run, each specimen having a selected characteristic and a number representative of said characteristic, said method comprising:

(a) analyzing, on an analyzer, a plurality of said patient medical specimens to obtain, for each specimen, the number representative of said selected characteristic of said specimen;

(b) determining a size shift to be detected in said number, said size shift being a target value shift;

(c) determining a mean from at least some of said numbers;

(d) determining a size shift to be detected in said mean in order to detect said target value shift, said size sift in said mean being a preselected amount;

(e) determining whether said mean shifts by said preselected amount;

(f) providing a control material containing said selected characteristic and being of known properties;

(g) determining expected control values for said control material when said control material is analyzed on said analyzer;

(h) ending said analytical run if said mean shifts by said preselected amount, by inserting said control material into said analyzer, and analyzing said control material therein;

(i) determining, from the analysis of said control material, whether said selected characteristic of said control material deviates from said expected control values by more than said predetermined amount; and

(j) determining, when said control material is analyzed on said analyzer and when such analysis indicates that the selected characteristic of said control material deviates from said expected control values by more than a predetermined amount, that said analyzer is incapable of detecting said target value.

2. A method according to claim 1 wherein said target value shift is a medically important shift, and wherein said analyzer may be subject to an inaccuracy and an imprecision and wherein the step of determining a size shift further comprises, using as said preselected amount the size shift in said mean which it is necessary to detect when said analyzer is exhibiting said inaccuracy and said imprecision, in order to thereby reliably detect said medically important shift.

3. A method according to claim 2 wherein said selected characteristic in said patient medical specimens has a variability (S_p) and said selected characteristic in said patient medical specimens when analyzed by said analyzer has a variability (s_p), and wherein said method further includes the step of determining the ratio s_p /s_a, and wherein step (c) further comprises choosing the number of said medical specimens used to obtain said mean whereby when said ratio there is a desired probability of determining whether said mean has shifted by more than said preselected amount.

4. A method according to claim 3 wherein said predetermined amount is Δ

SE_crit and is determined by the relationship Δ

SE_crit =[(TE_PT -bias)/s_meas ]-z, where;

TE_PT is said medically important shift, bias is a measure of said inaccuracy, s_meas is a measure of said imprecision, and z is a value indicative of a permitted defect rate.

5. A method according to claim 3 wherein said desired probability is at least 90%.

6. A method according to claim 1 further comprising the steps of reporting, if said selected characteristic of said control material does not deviate from said expected control values by more than said predetermined amount, the analyses of patient medical specimens analyzed in said analyzer prior to the analysis of said control material and resuming analysis of patient medical specimens by said analyzer, but not reporting, if said selected characteristic of said control material deviates from said expected control values by more than said predetermined amount, at least some of the analyses of patient medical specimens performed prior to the analysis of said control material.

7. A method according to claim 6 wherein said selected characteristic is the presence of a selected substance in said specimen.

8. A method according to claim 7 wherein said number represents the concentration of said selected substance in said specimen.

9. A method according to claim 7 wherein said substance is selected from the group comprising acid phosphatase, albumin, alkaline phosphatase, ALT (alanine transaminase), amalase, AST (aspartate transaminase), bilirubin, urea, calcium, cholesterol, creatine kinase, chloride, carbon dioxide, creatinine, iron, GGT (gamma glutamyl transferase), glucose, HDL (high density lipid)--cholesterol, lithium, lipase, potassium, LD (lactate dehydrogenase), magnesium, sodium, phosphate, triglyceride, total protein, urate, digoxin, ferritin, folate, free T4 (free thyroxine), FSH (follitropin hormone), hCG (human chorionic gonadotropin), IgE (immunoglobulin E), LH (lutropin hormone), prolactin, salicylate, total T4 (total thyroxine), TSH (thyrotropin stimulating hormone), total T3 (total triiodothyroxine), vitamin B12, WBC (white blood cells), RBC (red blood cells), platelets, MCV (mean cell volume), HCT (hematocrit), Hb (hemoglobin), PT/INR (prothrombin time/INR), and APTT (activated partial thromboplastin time).