REFERENCE VALUES Clause Samples

REFERENCE VALUES. The reference value for Plateletworks AA agonist tube was determined on samples collected from healthy volunteers. Each laboratory should establish their own reference range with their normal patient population.6 The data are as follows: AA 60-100% aggregation Plateletworks arachidonic acid aggregation was done on samples from volunteer donors. 134 samples were from individuals not taking aspirin and 265 were from individuals taking aspirin. The results are shown below. Normal (positive) = ≥60% Aggregation Abnormal (negative) = <60% Aggregation Overall Agreement 90.7% Positive Agreement 87.6% Negative Agreement 97.0% - Only fresh, human whole blood should be added to the Plateletworks tubes. Do not collect samples into blood collection tubes containing anticoagulant (i.e., sodium citrate, EDTA, or heparin) prior to addition to the Plateletworks tubes. - It is recognized that many drugs and compounds (prescription and non-prescription) may affect platelet aggregation. The most common of these is aspirin. Therefore, a complete medical history that includes a list of drugs taken for 7-10 days prior to testing should be obtained. - The validity of the Plateletworks assay is dependent on the accuracy of the platelet counts obtained. Multiple factors may potentially interfere with the accuracy of the platelet count when performed on an automated cell counter. Therefore, platelet counts obtained should be scrutinized in light of the patient’s clinical circumstance and previous platelet count results. Plateletworks results should always be interpreted in light of the clinical history and condition of the patient. - It may be beneficial for any abnormal baseline results to be further investigated using additional platelet testing methodology, such as platelet count, bleeding time, assessment of platelet morphology, and others. - Do not use Plateletworks tubes past their expiration date or those which have been improperly stored. - Plateletworks results may be affected by poor technique (e.g., improper blood sample volume, delayed test performance beyond recommended procedure, etc.).

REFERENCE VALUES. Reference range studies were established using 37 male and female adults with a total cholesterol of < 200 mg/dL. Alpha 12.6 - 46.6 Pre-Beta 0 - 57.1 Beta 21.7 - 67.7 Chylomicrons < 1.0 Any quantitation of Lp(a) must be added to pre-beta for an accurate total pre-beta. These values are intended as guidelines. Each laboratory should establish its own normal range study because of population differences in various regions.

REFERENCE VALUES. At birth, the majority of hemoglobin in the erythrocytes of the normal individual is fetal hemoglobin, HbF. Some of the major adult hemoglobin, HbA, and a small amount of HbA , are also

REFERENCE VALUES. The reference ranges presented were established with the Split Beta SPE System on 40 normal specimens using the SPIFE Nexus. These values are presented as a guideline. Albumin 47.3-62.7 Alpha1 1.8 - 4.3 Alpha2 7.3-14.4 Beta 13.5-19.7 Gamma 6.5-22.5 Each laboratory should perform its own normal range study. Variations of Expected Values5 Studies show that values are the same for both males and nonpregnant females (Some differences are seen in pregnant females at term and in women on oral contraceptives). Age has some effect on normal levels. Cord blood has decreased total protein, albumin, alpha2 and beta fractions, slightly increased alpha1 and normal or increased gamma fractions (largely of maternal origin). The gamma globulins drop rapidly until about three months of age, while the other fractions have reached adult levels by this time. Adult levels of the gamma globulins are not reached until 16 years of age. The albumin decreases and beta globulin increases after the age of 40.

REFERENCE VALUES. Lipoprotein cholesterol values vary according to age and sex26, and wide variations among different geographical locations and races have been reported6.. Therefore, it is essential that each laboratory establish its own expected range for its particular population. A total of 54 patients with normal total cholesterol (total cholesterol ≤ 200 mg/dL) were tested using the QuickGel Cholesterol system. These patients have not been differentiated by age, race or sex. These values should only serve as guidelines. HDL (%) 11.8 - 45.0 Lp(a)-C% 0.0 - 12.2 VLDL (%) 0.0 - 20.3 LDL (%) 47.6 - 77.5 Each laboratory should establish its own range for age, sex and race. The QuickGel Cholesterol system separates the major lipoprotein classes. The alpha band which migrates the farthest toward the anode corresponds to HDL. The next band, pre-beta, corresponds to VLDL. If a band appears between alpha and pre-beta, it is the Lp(a)-C band and should be added to the LDL quantitation when reporting the total LDL value.27 It does not appear in every sample at measurable concentrations. The slowest moving beta band corresponds approximately to LDL. Chylomicrons, if present, remain at the origin. H ▇▇▇▇▇ densitometers will automatically calculate and print the relative percent and the absolute values for each band when the specimen total cholesterol is entered. Refer to the Operator’s Manual provided with the instrument. Figure 1: A scan of a QuickGel Cholesterol pattern.

REFERENCE VALUES. The effective range of the c-ACT test is from 70 to 850 seconds. Blood samples collected from 18 normal females and 22 normal males, ranging in age from 30 to 50 years, were tested with the c-ACT test. The normal range (mean + 2 SD) was from 76 to 195 for noncitrated blood samples. These ranges should be used as a guideline only. Operators should establish their own normal ranges, based on their own population of normal individuals. The c-ACT results are similar to the ACT in the linear range of the ACT (1 to 6 U/mL heparin). Individual clotting responses to heparin depend on several factors and can vary considerably. In general, as heparin concentration is increased in the presence of Antithrombin, c-ACT clotting times will be progressively prolonged. Actual heparin levels and those predicted from the ACT and c-ACT tests can differ substantially by patient and by sample over the course of a cardiac procedure due to changes in concentrations of clotting factors and Antithrombin caused by hemodilution. During coronary bypass surgery the c-ACT clotting time appears to be less affected by hemodilution and the lowered temperature of a patient’s blood than the ACT.

REFERENCE VALUES. The reference range presented was established with the SPIFE Split Beta SPE and the QuickGel Split Beta SPE Systems on 48 normal specimens using the SPIFE 3000 Analyzer. These values are presented as a guideline. Protein Fraction X_ ± 2 S.D. Albumin 47.6 - 61.9 Alpha1 1.4 - 4.6 Alpha2 7.3 - 13.9 Beta 10.9 - 19.1 Gamma 9.5 - 24.8 Each laboratory should perform its own normal range study. Variations of Expected Values5 Studies show that values are the same for both males and nonpregnant females. (Some differences are seen in pregnant females at term and in women on oral contraceptives.) Age has some effect on normal levels. Cord blood has decreased total protein, albumin, alpha2, and beta fractions, slightly increased alpha1, and normal or increased gamma fractions (largely of maternal origin). The gamma globulins drop rapidly until about three months of age, while the other fractions have reached adult levels by this time. Adult levels of the gamma globulins are not reached until 16 years of age. The albumin decreases and beta globulin increases after the age of 40.

REFERENCE VALUES. At birth, the majority of hemoglobin in the erythrocytes of the normal individual is fetal hemoglobin, HbF. Some of the major adult hemoglobin, HbA, and a small amount of HbA2 are also present. At the end of the first year of life and through adulthood, the major hemoglobin present is HbA with up to 3.7% HbA2 and less than 2% HbF.3 A study of 47 normal adult specimens was done using the SPIFE system with the following results: HbA - 97.1% - 99.1% HbA2 - 0.9% - 2.9% These values should only serve as guidelines. Each laboratory should establish its own range.

REFERENCE VALUES. Protein S antigen values are usually expressed in relative percentages compared to a pooled normal plasma standard.