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BETACHEK Diabetes Test

Home Screening Test

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The BETACHEK Diabetes Test is a new screening test which enables the user to determine whether or not they have diabetes. This is the first diabetes test for home-use. It is simple to use and only takes 60 seconds.

 

Product

Product Code

QA

Pack Size

BETACHEK Diabetes Fasting Glucose Test

CB64/908

2 test strips

BETACHEK Glucose Visual Test

CB64/900

50 test strips

 

The Betachek Diabetes Test is intended to detect abnormal blood glucose levels which can be a sign of diabetes.

 

3 Simple Steps to Screen for Diabetes at Home

Step 1: Prick finger and apply blood to BETACHEK stick

Step 2: Wipe blood off finger over BETACHEK test area

Step 3: Read results in just 60 second

Principles of the Test: The reaction is based on the glucose oxidase/peroxidase reaction which along with chromogen indicators and non-reactive agents is contained in the reagent pads.

Chemical Composition: Each BETACHEK test strip contains: glucose oxidase 0.09%, peroxidase 0.19%, TMB 1.2%, DCP 0.35%

Specificity and Sensitivity: The test strips react specifically with D-glucose and do not react with other sugars that may be present in the blood. Glucose concentrations as low as 0.5mmol/l can be measured.

Accuracy and Precision: An independent clinical survey1 comparing BETACHEK (visually interpreted) to a reference method gave a R2=0.977. Precision studies at four different levels of glucose using lithium heparin capillary whole blood gave errors of <5% for all levels.

Calibration: BETACHEK is calibrated to whole blood. The calibration is traceable to a method of higher metrological order.

Measurement Range: The measurement range is 0.5-55mmol/l (9-991mg/dL)

Intended Use: BETACHEK Test Strips are intended for self-testing of blood glucose.

Contents of the Pack: 2 tests, 2 single-use lancets

Storage and Handling: Store BETACHEK strips in their original container in a cool dry place at 4-300C (39-860F). Do not freeze. Keep away from heat and direct sunlight. Avoid excess humidity. Do not use test strips past expiry date. Do not bend, cut or alter the test strips in any way. Use the test strips immediately after it is removed from the container, replace the container cap immeidately and close it tightly. Use the test strips only between 18 & 350C (64 & 950F).

Precautions and Limitations: Use only fresh capillary whole blood from a fingerstick. Do not use serum or plasma. Do not use venous blood. Results differ from capillary to venous blood. Venous blood tests are done via the laboratory. The test strips are for single use only. Do not touch the test area as it contains chemicals. Wash hands after accidental contact. Dispose of used test strips in an appropriate container. The glucose test may be affected by:

  • Highly lipaemic blood samples (containing abnormally high lipid contcentrations)
  • Extreme haematocrit values (at high haematocrit values i.e.>55% and glucose values above 11mmol/l, the value obtaine may be 15% too low. At extremely low haematocrit values, i.e. <35%, readings obtained may be up to 10% too high.

Errors: If a result you have obtained is unexpected, you should perform the test again to be sure. In many cases, incorrect technique can be the cause. Common errors include:

  • Expiry Date: check strips are in date
  • Incorrect timing: leaving the blood on too long will increase the result and wiping the blood too early will decrease the result
  • Inadequate blood: too little blood will give an incorrect result. A drop sufficient to cover the pad to all corners is rerquired
  • Moisture damage: the reagent pads are extremely absorbent. If the cap is accidently left off, for even just a short time, the test strips will be damaged by moisture
  • Contamination: do not handle the test pads as moisture, dirt and oil from the fingers will damage them. Dirty fingers carry traces of glucose from food and will distort the result. Therefore it is necessary to perform the entire process with cleanliness

 

Reference

1. Evaluation of a new visual reagent blood glucose test strip. Prince of Wales Hospital, Randwick. C. de Blieck, S. Colagiuri, R. Colagiuri.

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