ACT-Trol™

Analytical Control Systems, Inc

Analytical Control Systems, Inc.

info@analyticalcontrols.com

Phone ACS

317-841-0458

Fax ACS

317-841-3186

Mail ACS

Analytical Control Systems, Inc.

9058 Technology Drive

Fishers, IN 46038

Many of Analytical Control Systems, Inc. products are covered by US and foreign patents or patents pending.

Activated Clotting Time Controls
ACT-Trol™

ACS introduces a new set of controls for ACT instruments: ACS's Patented Whole Blood Clotting Time Control Set.

One of the most important factors in the management of patients who have been subjected to surgical intervention, dialysis and other highly disruptive procedures is the control of hemostasis. An important test used to assess hemostasis is the whole blood clotting time or the ACT test (Activated Clotting Time). This test can be performed near the patient without waiting for laboratory personnel to come, draw the sample, and return to the laboratory to run the required tests. However, because the ACT test is very different in nature and in use from traditional plasma tests, unique problems can arise.

A valuable aid to the coagulation user in any testing situation is the use of a quality control material. To the ACT test user, this is even more important. Availability of such a material enables the user to determine whether the instrument is functioning properly, whether one's technique is consistent from test to test and whether everyone using the instrument is doing so in a consistent manner. Judicious use of a quality control material will eliminate the need for repeating the test and will give the user more confidence in the result. However, in order for quality assurance to provide the best possible aid, a good control must be used. This quality control must be stable enough to survive shipping, storage and testing time; it must have consistent testing times; it must be sensitive enough to pick up system errors; it must be similar enough to normal samples so that the user's testing habits can be monitored; it must be available for bulk purchases with a single lot number; and, it must be cost efficient.

ACS's ACT-Trol™ provides all these advantages and more. It's animal based matrix (designed to perform like fresh human samples) combines the advantage of being free from human pathogens with all of the above mentioned stability and performance characteristics. ACS's philosophy towards customer service helps increase the usefulness of this product. For instance, controls from the same lot can be set aside when a customer commits to purchase a year's supply of ACS's ACT-Trol™ controls. With this one year's purchase comes a free technical assistance program, In-Service™, where a customer can request that an ACS representative come and help train personnel. In addition, ACS offers In-Sure™, its quality assurance program, also free of charge, when a customer commits to purchase a year's supply of ACS's ACT-Trol™ controls.

Quality Control Features

Stability

ACS's ACT-Trol™ demonstrates superior stability characteristics.

Most quality control materials are supplied as lyophilized powders. Because ACS has extensive experience in the manufacture and lyophilization of stable proteins and enzymes, the customer benefits from stable coagulation products. The stability of the reconstituted ACT-Trol™ is measured in hours, not minutes, the unreconstituted room temperature stability is seven days and refrigerated shelf life is up to 3 years.

Quality Control Features

Consistency

A year's supply of the same lot number of ACT-Trol™ Sets may be purchased, increasing its already high consistency even more.

Level I of the ACT-Trol™ has normal times for kaolin, celite and glass activators and certain specialty reagents. Level II has mildly prolonged times for kaolin, celite and glass activators and certain specialty reagents. Level III is set at extremely prolonged times on kaolin, celite and glass activators and certain specialty reagents. All of these controls show remarkable consistency, even on different instrument brands. The data for multiple customers (with different training levels in quality control technique) are shown below.

Typical Customer Test Results

Level I Consistency

Customers report results that demonstrate ACS's ACT-Trol™ is one of the most stable and consistent controls available.

Sample #	Hemochron† Results	Sample #	Hemochron Results
1	119 seconds	7	133 seconds
2	134 seconds	8	135 seconds
3	148 seconds	9	131 seconds
4	129 seconds	10	120 seconds
5	140 seconds	11	150 seconds
6	123 seconds	12	108 seconds

Data 12

Mean 130.8 seconds

SD 12.1

CV 9.3%

Table 12. Level I ACT-Trol™ was used at ACS location 2C-3 by nursing personnel for four years. Table 10 shows typical quality control results. Tests were performed on the Hemochron Instrument.

Sample #	HemoTec‡ Results	Sample #	HemoTec Results
1	84 seconds	10	109 seconds
2	88 seconds	11	87 seconds
3	94 seconds	12	77 seconds
4	90 seconds	13	100 seconds
5	89 seconds	14	96 seconds
6	74 seconds	15	96 seconds
7	99 seconds	16	104 seconds
8	97 seconds	17	96 seconds
9	93 seconds	18	106 seconds

Data: 18

Mean 93.3 seconds

SD 9.3

CV 9.9%

Table 13. Level I ACT-Trols™ were run at ACS location 7A-2 by point-of-care personnel. Table 11 shows typical results (for HR cartridges). Tests were performed on the HemoTec Instrument.

Sample #	HemoTec Results	Sample #	HemoTec Results
1	78 seconds	9	77 seconds
2	71 seconds	10	86 seconds
3	72 seconds	11	87 seconds
4	78 seconds	12	77 seconds
5	76 seconds	13	79 seconds
6	79 seconds	14	81 seconds
7	81 seconds	15	80 seconds
8	91 seconds

Data 15

Mean 79.63

SD 4.8

CV 6.0%

Table 14. Level I ACT-Trols™ were run at ACS location 8 by point-of-care personnel. This table shows typical results (for LR cartridges). Tests were performed on the HemoTec Instrument.

Typical Customer Test Results

Level II Consistency

Level II of ACT-Trol™ performs with the same level of accuracy and consistency as Level I. Customers repeatedly find that both levels perform to the same high standards.

Sample #	Hemochron Results	Sample #	Hemochron Results
1	223 seconds	8	209 seconds
2	219 seconds	9	198 seconds
3	205 seconds	10	208 seconds
4	227 seconds	11	184 seconds
5	199 seconds	12	206 seconds
6	214 seconds	13	180 seconds
7	209 seconds

Data 13

Mean 206.6 seconds

SD 13.9

CV 6.7%

Table 15. Level II ACT-Trol™ was used at ACS location 2C-3 for four years by nursing personnel. Table 13 shows typical quality control results. Tests were performed on the Hemochron Instrument.

Sample #	HemoTec Results	Sample #	HemoTec Results
1	422 seconds	10	459 seconds
2	383 seconds	11	400 seconds
3	436 seconds	12	370 seconds
4	409 seconds	13	459 seconds
5	455 seconds	14	448 seconds
6	463 seconds	15	455 seconds
7	440 seconds	16	467 seconds
8	463 seconds	17	427 seconds
9	497 seconds	18	433 seconds

Data 18

Mean 438.1 seconds

SD 32.1

CV 7.3%

Table 16. Level II ACT-Trols™ were run at ACS location 7A-2 by point-of-care personnel. Table 14 shows typical results (for HR cartridges). Tests were performed on the HemoTec Instrument.

Sample #	HemoTec Results	Sample #	HemoTec Results
1	324 seconds	9	317 seconds
2	303 seconds	10	347 seconds
3	315 seconds	11	341 seconds
4	309 seconds	12	333 seconds
5	303 seconds	13	329 seconds
6	297 seconds	14	333 seconds
7	318 seconds	15	309 seconds
8	354 seconds

Data 15

Mean 322.1

SD 17.1

CV 5.3%

Table 17. Level II ACT-Trols™ were run at ACS location 8 by point-of-care personnel. This table shows typical results (for LR cartridges). Tests were performed on the HemoTec‡ Instrument.

Typical Customer Results

Level III Consistency

Level III of ACT-Trol™ is remarkably consistent especially considering its extremely prolonged times. Level III HemoTec configured controls are set at about 500 hundred seconds. Level III for the Hemochron (set in the 300s) is shown below.

Sample #	Hemochron† Results	Sample #	Hemochron† Results
1	320	9	324
2	309	10	310
3	314	11	318
4	297	12	299
5	310	13	307
6	307	14	323
7	308	15	313
8	299

Data 15

Mean 310.53

SD 8.4

CV 2.7%

Table 18. Level III ACT-Trol™ was used at ACS location 0 by quality control personnel. Table 16 shows typical quality control results. Tests were performed on the Hemochron Instrument.

The data above was generated by running Hemochron's CA 510/FTCA 510 type of assay tubes. Although the range is slightly different because of the different activator, there is little difference in consistency and stability between Hemochron assay tube types. The same Level III control as above when run on P214/P215 type of tubes for the Hemochron gave results as follows:

Data 15

Mean 287.53

SD 13.2

CV 4.6%

Data for CA 510/FTCA 510 type of tubes for the Hemochron is very consistent.

ACT-Trol™ when performed on the P214/P215 assay tubes has a slightly different range but is just as tight in its range.

† Hemochron is a registered trademark of International Technidyne Corporation.

‡ HemoTec is a registered trademark of Medtronic HemoTec Inc.

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