Quantitative Flourescence Immunoassay Test cassette for Lung Cancer Treatment Monitoring

Cyfra21-1(CA211) Test Cassette (Serum/Plasma) is intended for in vitro quantitative determination of cytokeratin 19 in serum or plasma. Measurement of cytokeratin 19 is used as an aid in monitoring disease progression during the course of disease and treatment in lung cancer patients.

【SUMMARY】

Cytokeratin 19 fragment antigen (CYFRA 21–1) is an epitope of a polypeptide that is released following cell death ¹.Cytokeratin 19 has an isoelectric pH of 5.2 and a molecular weight of 40 kDa and is present in intermediate fifilaments of the cytoskeletal structure of normal epithelium and in malignant epithelium ².

In malignant epidermal tumors, activated proteinases accelerate cell degeneration and cause the release of soluble CYFRA 21–1 to tissues and body flfluids. CYFRA 21–1 has been reported to be the most sensitive tumor marker for nonsmall cell lung cancer (NSCLC) and appears to correlate with the development of disease ^3–5.Increased CYFRA 211 levels have also been described in non-malignant diseases (i.e.pneumonia, sepsis)⁶ and renal dysfunction⁷. Therefore evaluation of renal function (i.e. by measuring serum creatinine levels) should be considered in cases of high CYFRA 211 levels that are not consistent with the diagnostic and clinical characteristics of the patient.

【PRINCIPLE】

The Cyfra21-1 Test Cassette (Serum/Plasma) detects Cyfra21-1 based on Fluorescence Immunoassay. During testing,The sample moves through the strip from sample pad to absorbent pad. the specimen which contain Cyfra21-1 conjugated with fluorescence particles in the label pad of test cassette. Then the mixture migrates upward on the membrane chromatographically by capillary action and reacts with the Cyfra21-1 antibody in test line region of NC membrane. The concentration of Cyfra21-1 in the specimen correlates with the fluorescence signal intensity captured on the test line, which can be scanned by Fluorescence Immunoassay Analyzer. The testing result of Cyfra21-1 will display on the Fluorescence Immunoassay Analyzer screen.

【REAGENTS】

The test contains Cyfra21-1 antibody coated with cellulose nitrate membrane as the capture reagent and recombinant Cyfra21-1 antibody which conjugated with fluorescence particles as the detection reagent.

【PRECAUTIONS】

• For professional in vitro diagnostic use only.
• 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.
• 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).
• Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
• 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.
• Do not interchange or mix reagents from different lots.
• Humidity and temperature can adversely affect results.
• Used testing materials should be discarded in accordance with local regulations.
• Read the entire procedure carefully prior to any testing.
• The Cyfra21-1 Test Cassette is only operational in the FIA 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】

• The test should be stored at 4-30 °C until the expiry date printed on the sealed pouch.
• The test must remain in the sealed pouch until use.
• Do not freeze.
• Care should be taken to protect the components of the test 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】

• Specimen Collection

Collect the specimens according to standard procedures.

EDTA K2, Citrate sodium and Potassium Oxalate can be used as the anticoagulant for collecting the plasma specimens.

A clean tube without anticoagulants can be used to collect serum specimens.

• Specimen Storage and Shipping

Serum and plasma specimens may be stored at 2-8 °C for up to 7 days, and -20 °C for long term. Frozen specimens should be thawed and mixed before testing. Specimens should not be frozen and thawed repeatedly.

If specimens are to be shipped, these should be packed in compliance with local regulations covering the transportation of etiological agents.

• Preparation

Before performing the test, please balance the sample to room temperature (15-30 °C). Frozen specimens must be completely thawed and mixed well prior to testing.

【MATERIALS】

Materials Provided

• Test Cassettes • Specimen Dilution Vial with buffer

• ID Card • Package Insert

Materials Required But Not Provided

• Timer • Centrifuge • Fiatest^TM Fluorescence Immunoassay Analyzer

• Pipettes • Specimen collection containers

【DIRECTIONS FOR USE】

Refer to Fluorescence Immunoassay Analyzer Operation Manual for the complete instructions on use of the Test. The test should be in room temperature.

Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.

• Turn on the Analyzer power. Then according to the need, select “Standard test” or “Quick test” mode.
• Remove the ID card and insert it into the Analyzer port.
• Pipette 75μl of serum or plasma into the buffer tube,mix the specimen and the buffer well.
• Pipette 75μl of diluted specimen into the sample well. Start the timer at the same time.
• There are two test modes for Fluorescence Immunoassay Analyzer, Standard Test mode and Quick Test mode. Please refer to the user manual of Fluorescence Immunoassay Analyzer for details.

“Quick test” mode: Insert the test cassette into the Analyzer at 15 minutes after sample application, click “QUICK TEST”, fill the test information 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 sample application, click “STANDARD TEST”, fill the test information and click "NEW TEST" at the same time, the Analyzer will automatically counting down 15 minutes. After the countdown, the Analyzer will give the result at once.

【INTERPRETATION OF RESULTS】

Results read by Fluorescence Immunoassay Analyzer.

The test result of Cyfra21-1 is calculated by Analyzer and reported as the numerical value with unit ng/mL.

The detection range of Cyfra21-1 Test Cassette is 0.1-200ng/mL.

Reference range:<3.3ng/mL.