The HbA1c Test Cassette (Whole Blood) is based on Fluorescence immunoassay for
the quantitative detection of HbA1c in whole blood.The measure of HbA1c is
recommended as a marker of long-term metabolic control in persons with diabetes
mellitus. This test can be used as an aid in the diagnosis of diabetes and as an aid in
identifying patients who may be at risk for developing diabetes.
【SUMMARY】
The human erythrocyte is freely permeable to glucose. Within each erythrocyte a slow,
continuous, non-enzymatic process between hemoglobin A and various sugars takes
place. The product formed is known as glycated hemoglobin, or glycohemoglobin1 .
The chronic elevated blood sugar level of persons with diabetes mellitus will over time
cause damage to the small vessels of the body. This damage develops slowly over
years and is known to cause late complications. Good metabolic control, i.e. lowering
the HbA1c concentration, has proven to delay the onset and slow the progression of
diabeteslate complications2,3,4 .
It is concluded that measurements of HbA1c can be used to diagnose diabetes
mellitus. When in agreement with national regulations, Novatrend Plus HbA1c Test can be
used as an aid in the diagnosis of diabetes and as an aid in identifying patients who
may be at risk for developing diabete.
【PRINCIPLE】
The HbA1c Test Cassette (Whole Blood) detects HbA1c based on Fluorescence
Immunoassay. The sample moves through the strip from sample pad to absorbent
pad. HbA1c in the sample, attaches to the HbA1c antibody which is conjugated with
fluorescent microspheres. Then captured by hemoglobin(Hb) antibody coated on the
nitrocellulose membrane.The concentration of HbA1c in the sample correlates linearly
with the fluorescence signal intensity. According to the two fluorescence intensity,
Novatrend Plus Fluorescence Immunoassay Analyzer could calculate the value of HbA1c
percentage in the sample.
【REAGENTS】
The test includes HbA1c antibody coated fluorphores, Rabbit IgG coated fluorphoers,
Hb antibody and Goat anti Rabbit IgG coated on the membrane.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only.
2. Do not use after the expiration date indicated on the package. Do not use the test
if the foil pouch is damaged. Do not reuse.
3. This test contains products of animal origin. Certified knowledge of the origin
and/or sanitary state of the animals does not completely guarantee the absence of
transmissible pathogenic agents. It is therefore recommended that these products
be treated as potentially infectious, and handled observing usual safety
precautions (e.g., do not ingest or inhale).
4. Avoid cross-contamination of specimens by using a new specimen collection
container for each specimen obtained.
5. Do not eat, drink or smoke in the area where the specimens and tests are handled.
Handle all specimens as if they contain infectious agents. Observe established
precautions against microbiological hazards throughout the procedure and follow
standard procedures for proper disposal of specimens. Wear protective clothing
such as laboratory coats, disposable gloves and eye protection when specimens
are assayed.
6. Do not interchange or mix reagents from different lots.
7. Humidity and temperature can adversely affect results.
8. Used testing materials should be discarded in accordance with local regulations.
9. Read the entire procedure carefully prior to any testing.
10.The Novatrend Plus HbA1c Test Cassette should only be used with the Novatrend Plus
Analyzer by approved medical professionals.
【STORAGE AND STABILITY】
1. The kit should be stored at 4-30°C until the expiry date printed on the sealed
pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Care should be taken to protect the components of the kit from contamination. Do
not use if there is evidence of microbial contamination or precipitation. Biological
contamination of dispensing equipment, containers or reagents can lead to false
results.
【SPECIMEN COLLECTION AND PREPARATION】
Preparation
1. Before performing the test, please make sure that all components are brought to
room temperature(15-30℃). Cold buffer solution or moisture condensation on the
membrane can lead to invalid test results.
2. Take a tube with buffer solution out of the kit. Document patients name or ID on it.
Open the screw cap.
Blood Sample Taking
1. Collect the specimen according to standard procedures.
2. Do not leave specimens at room temperature for prolonged periods. Whole blood
collected by venipuncture should be stored at 2-8°C if the test is to be run within
half-day of collection. Do not freeze whole blood specimens. Whole blood collected
by finger stick should be tested immediately.
3. Bring specimens to room temperature prior to testing.
4. EDTA K2, Heparin sodium, Citrate sodium and Potassium Oxalate can be used as
the anticoagulant for collecting the specimen.
Sample Dilution / Sample Stability
1. The specimen (10ul of whole blood) can be added directly with the micro pipette
into the buffer.
2. Close the tube and shake the sample by hand vigorously for approximately 10
seconds to mix the sample and dilution buffer.
3. Let the diluted sample rest for approximately 1 minute.
4. It is best to test the diluted sample immediately.
【MATERIALS】
Materials Provided
• Test Cassettes • Specimen Collection Tubes with Dilution Buffer
• ID Card
• Package Insert
Materials Required But Not Provided
•Timer • FIATESTTM Fluorescence Immunoassay Analyzer
• Pipette • Specimen Collection Containers
【DIRECTIONS FOR USE】
Refer to Novatrend Plus Fluorescence Immunoassay Analyzer Operation Manual for the
complete instructions on use of the Test. The test should be conducted in room
temperature.
Allow the test, specimen, buffer and/or controls to reach room temperature
(15-30°C) prior to testing.
1. Turn on the Analyzer power. Then according to the need, select “Standard test”
or “Quick test” mode.
2. Take out the ID card and insert it into the Analyzer port.
3. Whole blood: Transfer 10 μL whole blood into the buffer tube with pipette; mix
the specimen and the buffer throughly.
4. Add diluted specimen with a Pipette: Pipette 75μl diluted specimen into the
sample well of the test cassette. Start the timer at the same time.
5. There are two test modes for Novatrend Plus Fluorescence Immunoassay Analyzer,
Standard Test mode and Quick Test mode. Please refer to the user manual of
Novatrend Plus Fluorescence Immunoassay Analyzer for details.
“Quick test” mode: Insert the test cassette into the Analyzer at 10 minutes after
sample application and click "Test", the Analyzer will automatically give the test
result after a few seconds.
“Standard test” mode: Insert the test cassette into the Analyzer immediately after
sample application, click "New test" at the same time, the Analyzer will
automatically counting down 10 minutes. After the countdown, the Analyzer will
give the result at once.
