SDMA- Stage Chronic Kidney Disease Kit

The Migibio SDMA Rapid Quantitative Test Kit measures symmetric dimethylarginine (SDMA) — a sensitive, muscle-mass-independent biomarker of glomerular filtration rate — for the early detection and staging of chronic kidney disease (CKD) in dogs and cats.

Product Specifications

Attribute	Value
Tests	10
Place of Origin	China
Storage	Room temperature
Shelf life	2 years

Intended Use

The SDMA test is a fluorescence immunoassay designed for use with an Immunofluorescence Analyzer for the quantitative determination of symmetric dimethylarginine (SDMA) in canine or feline serum or plasma. It is intended as an aid in the early detection and staging of chronic kidney disease (CKD).

For in vitro diagnostic use only. For professional use only.

Clinical Significance

Symmetric dimethylarginine (SDMA) is a sensitive renal biomarker that increases with as little as 25–40% loss of kidney function — much earlier than creatinine. Unlike creatinine, SDMA is minimally affected by muscle mass, making it especially valuable in young, geriatric, or cachectic patients.

Quantitative SDMA measurement enables early detection of chronic kidney disease (CKD), more accurate staging, and timely initiation of renoprotective therapy in both dogs and cats.

Test Principle

The test utilizes a quantitative fluorescence immunoassay technique. Fluorescent-labelled antibodies specifically bind SDMA present in the specimen. The fluorescence signal intensity reflects the amount of SDMA captured and is converted by the analyzer into a quantitative concentration value (µg/dL).

Specimen Collection and Preparation

The test is performed using serum or plasma. Separate serum or plasma (EDTA anticoagulant recommended) from blood within 3 hours of collection. If a specimen is severely hemolyzed, obtain and test a new specimen.

Perform the test immediately after specimen collection. If testing cannot be performed within 3 hours, store the specimen at 2 ~ 8℃ for up to 72 hours. For long-term storage, keep the specimen below -20℃ and avoid repeated freezing and thawing.

Test Procedure

Refer to the Immunofluorescence Analyzer Operation Manual for detailed instructions.

1. Bring all reagents and specimens to room temperature (18 ~ 28℃).
2. Insert the ID Chip into the analyzer and read the standard curve.
3. Pipette the prepared sample into the sample buffer and mix gently.
4. Pipette the mixed sample into the sample well (S) of the Test Device.
5. Run the Standard or Quick test mode on the analyzer and read the quantitative result.

Interpretation of Results

Results are reported quantitatively in µg/dL. The analyzer automatically calculates and displays the SDMA concentration. Each laboratory should establish a reference range representative of the population being evaluated. Persistently elevated SDMA values support a diagnosis of chronic kidney disease and inform IRIS staging and therapeutic decisions.

Warnings and Limitations

• This kit is for in vitro diagnostic use only.
• Do not use beyond the expiration date or if the pouch is damaged.
• Use a new pipette tip for each specimen.
• Factors such as technical error or interfering substances in the specimen may affect results.