SD A1cCare

The SD A1cCare is an optimized system applicable at the point of care testing field.

The SD A1cCare is a convenient small sized point of care instrument with optimized performance aided by no refrigeration and a long shelf life of the test panels.

TEST PROCEDURE

STEP 1

Insert a test panel

STEP 2

Take 5ul of blood sample and mix it with buffer solution

STEP 3

Apply mixed sample to the test panel

STEP 4

Check the result after 3 minutes

HIGH ACCURACY

You can trust SD A1cCare for enhanced precision and accuracy

SD A1cCare was tested in accordance with the Clinical and Laboratory Standards Institute (CLSI), and has successfully achieved NGSP and IFCC certifications

 

The purpose of NGSP is to provide internationally reliable and standardized HbA1c test results. Results may vary due to different laboratories, test methods and various quality controls. The NGSP aims to overcome such limitations of diabetes management and outcome analysis for patients with diabetes.

 

The International Federation of Clinical Chemistry Working Group (IFCC-WG) on HbA1c Standardization has developed reference methods for HbA1c analysis. They have established a laboratory network, which includes two reference methods, mass spectroscopy and capillary electrophoresis.

NO REFRIGERATION

PERFORMANCE

Accuracy: – R2 ≥ 0.98

Precision: CV < 3%

STORAGE CONDITION

RT: 1 30ºC (34 ~ 86ºF)

Shelf-life: 18 months

EVALUATION REPORT

Samples in the HbA1c ranges outlined in the NGSP method comparison procedures:

For the method comparison, 40 samples are analyzed by the manufacturer and by the SRL; one set of fresh samples may be split and used to evaluate several applications or methods, thus necessitating only one evaluation of 40 samples by the SRL.

Since method’s results were within the following NGSP criteria for Manufacturer Certification, SD Biosensor has successfully completed the NGSP Manufacturer certification.

  • Criteria for NGSP Manufacturer certification: 37/40 HbA1c result (single results) must be within ±7% of the NGSP SRL mean (mean of duplicate results).
  • Results of SD A1cCare: 38/40 HbA1c results (single results) were within ±7% of the NGSP SRL mean (mean of duplicate results).

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