I. PRINCIPLE OF MEASUREMENT:

Diabetes Mellitus is a leading cause of kidney failure, blindness, and amputation in adults. It is also a major risk factor for heart disease, stroke, and birth defects, and shortens average life expectancy by up to 15 years. It is well known that in patients with diabetes, blood sugar levels affect the complications linked to the disease. Doctors recommend checking HbA1c to monitor the long-term care of people with diabetes. A1c reflects the average level of blood sugar over the previous 2–3 months. The higher the blood sugar levels, the higher the A1c. The in2it (II) System shows how good glucose control has been over a two to three month period.

II. INTENDED USE: 

HbA1c determination by in2it analyzer is based on boronate affinity chromatography. The system is intended for testing blood taken from a fingerstick or whole venous blood collected in EDTA and does not suffer interference in presence of HbS and HbD. ⁽⁴⁾ The in2it (II) System is a small, portable, fully automated Point-of-Care-Testing system for all healthcare situations.

The in2it (II) Analyzer and test is CLIA waived. For in vitro diagnostic use only. In2it (II) has been cleared by the FDA for use in the clinical laboratory

III.    EQUIPMENT AND MATERIALS:

IV.    SPECIMEN:  The in2it (II) test is performed on a fingerstick blood sample. Venous sample collected in EDTA can also be used.

V.     IMPLEMENTATION:

1.	When the Analyzer is ready to run a test, the cartridge symbol will flash. Press the button under the cartridge symbol to start a test.( See in2it (II) System A1C TEST Cartridges Instruction Manual for a list of cartridge symbol)
2.	The Analyzer door will open and it is now ready to accept a cartridge.
3.	Place a cartridge in the cartridge workstand with the blue blood port at the top.
4.	Prick the finger and squeeze to develop a good drop of blood.
5.	Hold the blood key by the round handle and touch the flat end to the edge of the blood drop. Blood will be drawn into the blood key. Take care not to get blood on the outside of the blood key.
6.	Immediately (within 10 seconds) push the blood key through the blue blood port until it clicks into place. You will feel two separate clicks. Twist the handle of the blood key until it snaps off. The blood key should be smooth with the surface of the test cartridge. Discard the handle.

VI.    INTERPRETATION OF RESULTS:

A test result above 7% means that the day-to-day glucose levels are above the recommended levels. The analyzer will report results between 4 and 14%. If the result is below 4% it will be reported as "Lo", and if it is above 14% it will be reported as "Hi".

VIII.   PRECAUTIONS AND WARNINGS  (SPECIAL CONSIDERATIONS):

IX.  STORAGE AND STABILITY:

a.   TEST CARTRIDGE:

1. Store the test cartridges in their original container. The test cartridges are stable until the expiration date printed on the box when stored at 36–46 °F (2–8 °C). Do not freeze. The test cartridges should be allowed to reach room temperature for at least two hours before use.
2. The test cartridges are stable for 30 days when stored at a room temperature of 59–77 °F (15–25 °C). When storing at room temperature, write the date that the test cartridges will expire on the side of the box to ensure that the test cartridges are not used beyond 30 days.

b.   SYSTEM CHECK CARTRIDGE:

1. The in2it System Check Cartridge must be stored away from sunlight.
2. Do not use after the expiration date printed on the outside of the System Check Cartridge box.
3. If the Cartridge is stored in the refrigerator, it must be left at room temperature for at least two hours before use.
4. Always store the in2it System Check Cartridge in its packaging. This will help to protect it from scratches which may affect the result.

X.  QUALITY CONTROL:

1. The in2it System Check Cartridge (SCC) checks that the instrument is working correctly. The SCC checks that the optical and operating systems of the analyzer.Liquid Quality Controls should be run
2. regularly to check that the test cartridges are working correctly.

XI.    QUALITY CONTROL FREQUENCY:

XII.  QUALITY CONTROL PROCEDURE: System Check Cartridge.

The SCC contains optical filters; it is reusable. The Analyzer reads the barcode on the SCC, reporting and storing the result with the letters "SCC". The SCC is optically calibrated to enable the Analyzer's optics and systems to be routinely checked.

1. Action: If the result is within the range printed on the SCC box. Use meter for patient testing.
2. Remedial Action: If the result is out of range, do the following:
   1. Check the date on the box to ensure that the SCC is not being used beyond its expiration date.
   2. Check the SCC for any dirt, scratches, or other damage.
   3. If the plastic surfaces or the barcode are damaged, replace the SCC with a new one.
   4. If the SCC does not appear damaged, clean both the inside and outside clear plastic surfaces of the SCC with a soft, lint-free cloth.
   5. Rerun the SCC.
   6. If the result is still out of range do not use the equipment for patient testing. Collect a venous EDTA sample and send the patient test to St. Peter’s Hospital Laboratory for testing. Immediately contact Point-of-Care-Testing Coordinator, extension # 2965 or call the lab extension # 2803.

XIII.   QUALITY CONTROL PROCEDURE : Liquid control

NOTE: If the reconstituted controls have been stored at 2–8 °C (36–46 °F), allow them to reach room temperature before use. Before using the reconstituted control, gently swirl the bottle several times to ensure complete mixing.

1. Action: If the result is within the range for the control. The cartridge lot may be used for patient testing.
2. Remedial Action: If the result is out of range notify Point-of-Care-Testing Coordinator. Do not use the equipment until cleared by St. Peter’s Hospital  POCT department.

XIV. GENERAL MAINTENANCE:

If the in2it (II) Analyzer becomes dirty, clean the outside carefully with a clean damp cloth. If necessary, a mild detergent or disinfectant may be used such as a 5% hypochlorite, bleach solution or isopropyl alcohol. Do not use stronger products such as acetone. Do not pour or spray cleaning fluid directly onto the Analyzer. These chemicals are corrosive and harmful by ingestion, inhalation and contact through the skin and should only be used in well ventilated areas.

XV.  EQUIPMENT AND PERFORMANCE EVALUATION:

The in2it (II) Analyzer has been designed for a long and fault-free life. The Analyzer may be used with confidence for as long as the System Check Cartridge and Quality Control materials give acceptable results.

The appearance of error conditions may be a sign of wear on the Analyzer and may indicate that the Analyzer has reached the end of its useful life. The Analyzer must then be disposed of in line with local regulations concerning the disposal of electrical and electronic waste items.

XVI.  LIMITS OF THE TEST:

Do not use any part of the test components beyond the marked expiration date. Store the test according to the instructions on the box. Always wear gloves when handling blood samples.

XVII.  INTERFERENCE: VHF (Very High Frequency) Warning Statement WARNING: When using the in2it (II) Analyzer, do not operate any FM emitting equipment within 3 feet.

XVIII.  ALTERNATIVE PROCEDURE: Collect blood sample in EDTA (Purple top tube) and send sample to ST. Peter’s Hospital Laboratory for testing

XIX.  SAFETY PRECAUTIONS:

1. Always wear single use disposable gloves when handling other people’s blood.
2. Do not use the test cartridges past the expiration date.
3. Store the test according to the instructions on the box.
4. After finishing the test, all items must be disposed of carefully.

XX.   PRODUCT SAFETY INFORMATION:

Cartridges contains:

1. Sample Solution: R22, S35–36 Harmful Contains Sodium Azide.
2. Wash Solution: R22, S35–36 Harmful Contains Sodium Azide.
3. Elution Solution: R22, S35–36 Harmful Contains Sodium Azide. R22 Harmful if swallowed. S35 this material and its container must be disposed of in a safe way. S36 Wear suitable protective clothing.

XX1.    TROUBLE SHOOTING: For Error Code Messages see operational manual. Notify Point-of-Care-Testing coordinator of operational problems.

XXII.   DOCUMENTATION: Place the print out from the in2it printer on the Log Sheet. Record the result in Meditech. The Meditech Mnemonic for the test is:  CLI HGBA1C.

XXIII.  SPH SITES PERFORMING:

SPMG Lab. All personnel performing this test must be enrolled in St. Peter’s Hospital competency Program

XIV.    REFERENCES:

1. BIO-RAD in2it (II) System Analyzer Operation Manual, June 2007 L81000000 201433V Rev01, BIO-Rad Laboratories Deeside, CH5 2NU, UK
2. BIO-RAD in2it (II) System Accessories June 2007 L8 1000500 201452R Rev01, BIO-Rad Laboratories Deeside, CH5 2NU, UK
3. BIO-RAD in2it (II) System A_1C Test Cartridges Instruction Manual L81000800 201434T Rev 01, BIO-Rad Laboratories Deeside, CH5 2NU, UK
4. Assessment of the in2it™ Point of Care (POC) System for HbA1C 7-11 June- Innsbruck Congress Center- Innsbruck Austria

Approved by: Laboratory Medical Director                         Date: 8/9/09

(See: Procedure on file in POCT office)