Roche #05213312160 - CoaguChek Accutrend Cholesterol Test Strips, 25/vial

Roche #05213312160 - CoaguChek Accutrend Cholesterol Test Strips, 25/vial
CIA1067030
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Product Description

Roche Part #05213312160 - CoaguChek Accutrend Cholesterol Test Strips, 25/vial

Cholesterol is a substance which is naturally produced by the liver and is found in many foods. When the blood cholesterol level in the body reaches a certain point, it can build up in the arteries. This may lead to an increased risk of heart disease or stroke. The Accutrend Cholesterol test is an easy-to-use test for home use that lets you measure the level of total cholesterol in your blood in minutes. Total cholesterol testing helps detect those persons that may be at risk for coronary heart disease. The Accutrend Cholesterol test strip, used as directed with an Accutrend Plus or Accu-Chek InstantPlus meter, will accurately measure your total cholesterol level. The strip changes color as it reacts to total cholesterol in a drop of blood and the meter measures this color change. Your total blood cholesterol is then displayed on the display screen.

05213312160 Test strips for the quantitative determination of total cholesterol in capillary whole blood. For use by health care professionals and for home use by people with diabetes for cholesterol screening. For use with Accutrend Plus and Accu-Chek InstantPlus meters. Before using these test strips read this package insert and the Users Manual carefully.

Strip Storage and Handling

  • Tightly re-cap the container immediately after removing a test strip. Exposure to light and moisture may discolor the test strips which may lead to an incorrect result.
  • Do not cut or alter the test strips in any way. This will lead to an incorrect test result or an error code.
  • Store strips at 36 F (2 C) to 86 F (30 C). Do not freeze.

What Does My Result Mean?

The National Cholesterol Education Program recommends that repeated measurements of cholesterol be done to find out your baseline (beginning) value. At least 2 or 3 tests should be performed over a period of several weeks. The average of these values will determine your baseline cholesterol level. See your physician for more information on your baseline value.1 The total cholesterol results and suggested actions below are for adults 20 years and older.

Performance Characteristics

The data shown represents typical performance results for the Accu-Chek InstantPlus and Accutrend Plus meters.

Precision: Overall and within-run precision was very good at all levels. Overall precision was collected on multiple meters, strip containers, and control bottles over multiple days. The testing yielded the following results:

Accuracy

Trained Technician Study

Studies were conducted by trained technicians at six professional sites, where patient results were compared to a serum Abell-Kendall reference. These studies, where N = 490 different patients, yielded the following accuracy data: y = 1.057x - 14.9 r = 0.920 At 200 mg/dL, bias was -2.3 % with a total error of 15 %. At 240 mg/dL, bias was -0.2 % with a total error of 13 %.

Consumer Study

Studies were conducted by untrained patients at six professional sites, where patient results were compared to a serum Abell-Kendall reference. These studies, where N = 490 different patients, yielded the following accuracy data: y = 1.023x - 11.8 r = 0.881 At 200 mg/dL, bias was -4.4 % with a total error of 19 %. At 240 mg/dL, bias was -1.8 % with a total error of 18 %.

Unusual Test Results

If your total blood cholesterol value seems unusually high or low there may be a problem with your test procedure, test strip or meter.

The following can cause unusually high or low results:

  • Test strip was not stored in container with cap tightly sealed.
  • Test strip was used after expiration date.
  • Test strip was stored in extreme temperatures.
  • Proper maintenance and handling procedures for the Accutrend Plus or Accu-Chek InstantPlus meter have not been followed.
  • The blood drop was too small.