SERUM STARTER SAMPLING PROCEDURE

Method Reagent Blank Reagent Dynamic

End Point - Fixed Time

Kinetic - I.R. Single + S.S. R1 R1 + Tr + S ⇒Ts ⇒ L End Point - Fixed Time

Kinetic - I.R. Double + S.S. R1 + Tr + R2 + Tr R1 + Tr + R2 + Tr + S + Ts ⇒ L End Point - Fixed Time

Kinetic - I.R. Double + S.S. R1 + R2 + Tr R1 + R2 + Tr + S + Ts ⇒ L S.S. = Serum Starter, Tr = Delay Time for R1 and R2, Ts = Serum Incubation Time, L = Reading The way the Reagent Blank and the Reaction’s Dynamics are used is tabulated below:

End Point Reagent blank. Final reaction datum detection (at the end of programmed time for

incubation and reading) and concentration’s value computation.

Fixed Time Reagent’s reading check. Data detection during programmed reading time, absorbance

delta determination (∆A) and concentration’s value computation.

Kinetic Reagent’s reading check. Data detection during programmed reading time,

determination of the absorbance delta per minute (∆A/min.), processing of the linear regression and computation of the concentration's value.

Initial Rate Reagent’s reading check. Data detection during programmed reading time,

determination of the absorbance delta per minute (∆A/min.), processing of the linear regression and computation of the concentration’s value.

Sample Blank (A) Reagents’ reading only for check (R1+R2); first phase (sample blank) with reagent 1

and sample (data detection at the end of incubation time 1), second phase (analysis) adding reagent 2 (data detection at the end of incubation time 2), absorbance delta determination (∆A) between first and second phase and concentration’s value computation.

Sample Blank (A-b) Blank Reagent (R1+R2); first phase (sample blank) with reagent 1 and sample (data

detection at the end of incubation time 1), second phase (analysis) adding reagent 2 (data detection at the end of incubation time 2), absorbance delta determination (∆A) between first and second phase and concentration’s value computation.

Sample Blank (B) Reagent’s reading only for check with R2 (Working Reagent); first phase (sample

blank) with reagent 1 and sample (data detection at the end of incubation time 1), second phase (analysis) with reagent 2 and sample (data detection at the end of incubation time 2), absorbance delta determination (∆A) between first and second phase and concentration’s value computation.

Sample Blank (B-b) Blank Reagent with R2 (Working Reagent); first phase (sample blank) with reagent

1 and sample (data detection at the end of incubation time 1), second phase (analysis) with reagent 2 and sample (data detection at the end of incubation time 2), absorbance delta determination (∆A) between first and second phase and concentration’s value computation.

Only Read * (End-Point)

Reagent blank. Final reaction data detection (at the end of programmed time for reading) and concentration’s value computation.

End Point 2 points

Reagent’s reading check. Data detection during programmed reaction time (first datum in incubation time and the last datum in reading time), absorbance delta determination (∆A) and concentration’s value computation.

End Point Absolute

Without Blank Reagent (reading only with reference to H2O). Final reaction data

detection (at the end of programmed time for reading) and concentration’s value computation. However the Blank is read to verify the reagent.

* During Only Read (End-Point) analyses, the analyzer uses the reactive just to prepare the reagent blank. The analysis’ procedure requires then to sample at least 300 µl from the final solution in the sample cups and pour it into the cuvettes for the reading phase. Only single reagent use is allowed.

For the End Point, Kinetic, Fixed Time, Initial-Rate and End-Point 2 Point methods it is possible to use single and double reagent methodologies. The Only read method uses only a single reagent, and the Sample Blank (A) & (B) methods require exclusively double reagent methodologies.

1.3. ANALYSIS PROGRAMMING

The analyzer can store virtually endless analysis codes (with parameters). There are two different codes’ lists: a "global" (All Tests) list where all programmed codes are stored, and an "on-line reagents tray" (Current Tray) list, where only the codes for the analyses that have their reagent in the tray are stored. Patients, standards and controls can be programmed and performed only for the on-line list.

Figure 6 Figure 7

The analysis programming page can be accessed from the main menu (Tests) or from the specific icon that gives direct access (see Chapter A, paragraph 3., icon n°1 in the Function Icons Bar) (Fig. 6).

To set out new analyses it is necessary first to create the code (this function is enabled only in the All Tests) and then to assign the parameters, the standards and the controls (these are enabled also in the Current Tray). To perform any test it is necessary to move its code from the All Tests to the Current Tray by using the command Modify Current Tray (Function Icons Bar, icon n°2). Once the Current Tray is created, it will be possible to assign a position to each reagent bottle.

1.3.1. CREATING A NEW CODE

Open the analysis programming page and select New Code. Enter the test’s code and select the Test Type among the options showed by clicking on the button"u". The test type, defines whether the programmed test is a Clinical Chemistry, an I.S.E. (if enabled, refer to Chapter L) or a relation test (mathematical computation, refer to paragraph 1.3.2. Relation tests). Use the button Save to memorize the test, or press Cancel to exit and abort programming. Any code can be deleted with Clear Code or modified with Rename. Once a code is set, it is possible to program the analytical parameters (see paragraph 1.3.3. and the following).

1.3.2. RELATION TESTS

Figure 8

Once the code has been created for the relation test (as shown in Fig. 8), it is possible to program its general parameters and the related mathematical function. In the analyses list click on the code (the check symbol will be displayed), then select Parameters.

Figure 9

In the parameters window (fig. 9) enter the following information: Name: complete test name

1st Unit: measurement unit. Clicking on the 2nd Unit it is possible to enter a secondary unit, with its conversion factor (the analyzer will multiply the 1st unit by the given factor).

Supplementary Factor: The result of the mathematical function will be multiplied also by this value. This is simply an additional calculation offered by the analyzer.

Normal Range: insert the min. and max. values of the normal range for male, female and child.

Decimals: it is possible to choose the number of decimals after the point. Leaving the "Automatic" option the analyzer will follow this principle (floating point):

for values like 0.XXX three decimals for values up to 9.XX two decimals for values up to 99.X one decimal for values over 100 no decimals To enter the mathematical function select Function

Fig. 10.a

Fig. 10.b

A window divided in two parts will be displayed: one for the calculator and one for the analyses list (current tray), Fig. 10. The mathematical function can be composed of simple values and operations or can recall sample results acquired by the analyzer (serum and urine) on other tests (complex function). To enter a simple mathematical function avail yourself of the calculator. To enter a complex function, select the code of the test to be inserted into the function. A small field will appear, where it is possible to select between serum or urine results for that test. Then complete the function with the needed operations. To create more complex functions (involving more than one test’s result) it is advisable to use the parenthesis as for all normal mathematical functions. Ex. For the creatinine clearance with urine/24h = 900ml [(urine CRE x urine ml 24/h)/(serum CRE x 1440)] the formula would be: ( [CRE&U] * 900) / ([CRE&S] * 1440).

The button Test Function (Fig. 10.b) is used for checking the relation test result from the analyzer, based on values given to the tests involved in the function. This option is useful for verifying the correct use of values and parenthesis in the formula.

The other options (Figure 9) available are: Save: saves and exits from the window. Print: prints parameters.

Cancel: exits without saving.

Note. The relation tests can be inserted into the available analyses’ list for the current tray, even if they have no determined reagent position (refer to paragraph 1.7. Modify Current Tray). The result for a relation test can be returned only if both the test itself and all the other analyses involved in the function are present in the current reagent tray.

1.3.3. PRIMARY ANALYTICAL PARAMETERS

From the page All Tests or Current Tray select the desired test code, then move mouse cursor over Parameters and click to confirm.

In the displayed page, the analytical parameters for the chosen test are shown: they are divided into Primary Parameters, Secondary Parameters and Check Parameters. By clicking on the > or < buttons it will be possible to go to the next or previous test parameters.

The first screen shows Primary Parameters, to display the other screens click on the corresponding tags.