HbA1c Direct 20 Infinite (Without Calibrator)

HbA1c Direct 20  Infinite (Without Calibrator)

Product Details:

  • Smell Other
  • Shelf Life 18 Months
  • Other Names Biochemistry reagent
  • Shape other
  • Physical Form Liquid
  • Appearance Powder & Liquid
  • Taste Other
  • Supply Ability : 10000 Kit Per Day
8820 INR/Kit
X

Price And Quantity

  • 1 Kit
  • 8820 INR/Kit

Product Specifications

  • Other
  • Reagents
  • Biochemistry reagent
  • 100
  • Liquid
  • other
  • Powder & Liquid
  • Biochemistry reagent
  • 18 Months
  • Biochemistry reagent
  • Other
  • ACC555
  • Other

Trade Information

  • EXW ABPL
  • Cash Against Delivery (CAD), Cash in Advance (CID), Cheque, Letter of Credit (L/C), Letter of Credit at Sight (Sight L/C)
  • 10000 Kit Per Day
  • 2 Days
  • Yes
  • packaging : Empity
  • Asia, Australia, Central America, North America, South America, Eastern Europe, Western Europe, Middle East, Africa
  • All India
  • certification : iso

Product Description

INTRODUCTION
  • A reagent kit for direct quantitative determination of hemoglobin A1c (HbA1c) in whole blood
  • A ready-to-use, two liquid reagent system
  • The assay which is linear up to 16% (NGSP)
PRINCIPLE

Infinite HbA1c assay is based on antigen-antibody interaction to directly determine the HbA1 c concentration in whole blood. Total hemoglobin & HbA1c have the same unspecific absorption rate to latex particles. When mouse anti human HbA1c monoclonal antibody is added, latex-HbA1c-mouse anti human HbA1c antibody complex is formed. Agglutination is formed when goat anti-mouse IgG polyclonal antibody interacts with monoclonal antibody. The amount of agglutination is proportional to the concentration of HbA1c in the specimen and is measured photometrically.

SHELF LIFE

Stable till expiry date indicated on the label when stored at 2 degree C - 8 degree C.

OPEN VIAL REAGENT STABILITY

  • R1: 4 weeks at 2 degree- 8 degree C after opening
  • R2: 4 weeks at 2 degree - 8 degree C after opening
  • Protect the reagent from light and contamination. Do not freeze the reagent 
To ensure adequate quality control, it is recommended that the laboratory should use a normal and an abnormal commercial reference control material. It should be realized that the use of quality control material checks both reagent and the instrument functions together. The value of these controls should fall within the specified limits. If control values fall outside the specified limits, each of the below criteria

Should be cross-checked and corrected:
  • Proper instrument function  wavelength setting, light source and temperature control.
  • Cleanliness of probes and cuvettes.
  • Bacterial contamination of wash water used by the instrument.
  • Expiry date of the reagent kit.
SPECIMEN COLLECTION & PRESERVATION

Collect sample using standard sampling tube. Whole blood with EDTA is the specimen of choice. HbA1c in whole blood collected with EDTA is stable for one week at 2 degree - 8 degree C.
To determine HbA1c, a hemolysate must be prepared for each sample a follows:
  • Dispense 0.5m1 Haemolysis reagent into
  • appropriately labeled tube.
  • Add 10p1 of well mixed whole blood.
  • Mix well and allow to stand for 5 minutes or until complete lysis is evident.
PROCEDURE FOR SEMI-AUTOMATED ANALYZERS
  • Reaction Type: End Point
  • Reaction direction: Increasing
  • Wavelength: 650 nm
  • Flow Cell temperature: 37 degree C
  • Zero Setting with: Reagent Blank
  • Sample Volume: 10 NI
  • Reagent 1 (R1) volume: 360 NI
  • Reagent 2 (R2) volume: 120 pl
  • Linearity: 16%
Labile intermediates (Schiff base) and Hemoglobin variants (HbA2, HbC & HbS) do not interfere with this assay. Elevated levels of HbF may lead to underestimation of HbA1c. Results may be inconsistent in patients with conditions of opiate addiction, lead poisoning, alcoholism & large dose of aspirin ingestion.

EXPECTED VALUES

According to NGSP:
  • Non-diabetic: Less than 6%
  • Good Control: Less than 7%
  • Poor Control: More than 7%

Reproducibility was determined using two levels of sample as shown below:

 

Within Run

Between Run

Sample

Mean
%

SD%

%CV

Mean
%

SD%

%CV

Low

5.48

(3.98

1.43

5.48

0.152

2.77

High

10.48

16.7

1.72

10.28

0.275

2.68


CALIBRATION

For calibration it is recommended to use 4 x 0.5 ml HbA1c calibrator from Accurex.
Generate 5 point non-linear calibration curve (Use saline as first calibrator with concentration ). Other commercially available HbA1c calibrators have not been tested with the assay and may not be supported by Accurex HbA1c. Refer to Accurex HbA1c calibrator kit package insert for a description of assignment procedures and instruction.
CALIBRATION FREQUENCY

Re-calibration is recommended:
  • Whenever the reagent lot is changed.
  • As per the requirement of quality control procedures.
QUALITY Control

Each batch of Accurex HbA1c is assayed with multiple quality control material prior to release.

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