The β2MG Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic
immunoassay for the quantitative detection of β2MG in whole blood or serum or plasma
to aid in the diagnosis of renal function.
【SUMMARY】
β2 microglobulin also known as B2M is a relatively small molecular weight protein with a
molecular weight of 11.8 kD. It is present in all nucleated cells except red blood cells and
placental trophoblasts, especially in lymphocytes and monocytes, and plays an important
role in its immune response effect. The ability of tumor cells to synthesize β2-MG is also
very strong. It binds to the heavy chain as a light chain of HLA with a non-covalent bond.
Due to its small molecular weight, it can pass through the glomerular filtration membrane.
The filtered β2-MG is almost completely reabsorbed in the proximal tubules, and the
absorption rate is 99.92%. The reabsorbed β2-MG is completely degraded in the renal
tubules. [1]
β2-MG measurement is a sensitive indicator for the diagnosis of proximal convoluted
tubule injury. Blood β2-MG is elevated and urinary β2-MG is normal, mainly due to
decreased glomerular filtration function, which is common in acute nephritis and renal
failure. Blood β2-MG is normal and urinary β2-MG is elevated, mainly due to the obvious
impairment of renal tubular reabsorption function, which is found in congenital proximal
convoluted tubule function, fanconi syndrome, and renal transplant rejection. In addition,
there is a certain value in the diagnosis of tumors. [2]
β2-MG can also be used for the diagnosis and treatment monitoring of kidney
transplantation, diabetic nephropathy, gout kidney and some malignant tumors.
【PRINCIPLE】
The Novatrend Plus β2MG Test Cassette detects β2MG based on Fluorescence
Immunoassay. The sample moves through the strip from sample pad to absorbent pad. If
the test sample contains β2MG, it attaches to the β2MG antibody which is conjugated
with fluorescent microspheres. Then the complex will be captured by the capture
antibody coated on the nitrocellulose membrane (Test line).The concentration of β2MG in
the sample correlates linearly with the fluorescence signal intensity captured on the T line.
According to the fluorescence intensity of the test and product standard curve, the
concentration of β2MG in the sample can be calculated by Analyzer to show β2MG
concentration in specimen.
【REAGENTS】
The test cassette contains anti-β2MG antibody coated particles and anti-β2MG antibody
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 β2MG Test Cassette is only operational in the Novatrend Plus
Analyzer. And tests should be applied by professionally trained staff working in
certified laboratories at some remove from the patient and clinic at which the
sample(s) is taken by qualified medical personnel.
【STORAGE AND STABILITY】
1. The test 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 test from contamination.
5. 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】
Sample Taking
Collect the specimen according to standard procedures.
Do not leave specimens at room temperature for prolonged periods. Serum and
plasma specimens may be stored at 2-8°C for up to 3 days, for long term storage,
specimens should be kept below -20°C. Whole blood may be stored at 2-8°C up to 2
days and do not freeze.
Bring specimens to room temperature prior to testing. Frozen specimens must be
completely thawed and mixed well prior to testing. Avoid repeated freezing and
thawing of specimens.
EDTA, Heparin sodium, can be used as the anticoagulant tube for collecting the blood
specimen.
【MATERIALS】
Materials provided
• Test Cassettes
• Specimen Collection Tubes with buffer
• ID Card
• Package Insert
Materials required but not provided
• Timer
• Centrifuge
• Specimen Collection Containers
• Novatrend Plus Fluorescence Immunoassay Analyzer
• Pipette
【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 in room temperature.
Allow the test cassette, 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. Remove the ID card and insert it into the Analyzer port.
3. Pipette 10μl of specimen into the buffer tube, and then mix thoroughly.
4. Pipette 75μl diluted sample into the sample well. 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: After 10 minutes of adding sample,Insert the test cassette into
the Analyzer and click "New test" immediately,The Analyzer will automatically give
the test result after a few seconds.
“Standard test” mode: Insert the test cassette into the Analyzer immediately after
adding specimen, click "New test" at the same time, The Analyzer will automatically
countdown 10 minutes. After the countdown, the Analyzer will give the result at once.
