Cytomegalovirus CMV IgG/IgM Combo Rapid Test Cassette(W/S/P)

【INTENDED USE】

The CMV IgG/IgM Rapid Test Kit is a lateral flow chromatographic immunoassay for the simultaneous detection of Cytomegalovirus (CMV) IgG and IgM antibodies in human whole blood, serum or plasma.

【PRINCIPLE】

CMV IgG/IgM test device has 3 pre-coated lines, “IgG” (CMV IgG Test Line), “IgM” (CMV IgM Test Line) and “C” (Control Line) on the surface of the membrane. All three lines in result window are not visible before applying any samples. The “Control Line” is used for procedural control. Control line should always appear if the test procedure is performed properly and the test reagents of control line are working. A purple “IgG” and “IgM” lines will be visible in the result window if there are enough IgG and/or IgM antibodies to CMV in the sample. If IgG and/or IgM antibodies to Cytomegalo viurs are not present in the sample, there is no color appearance in “IgG” and/or “IgM”.

【CONTENTS】

• Rapid Test.

• Buffer

• Disposable pipettes

• Instruction for use.

【STORAGE AND STABILITY】

• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.

• The test must remain in the sealed pouch until use.

• Keep away from direct sunlight, moisture and heat.

• Do not freeze.

• 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.

【PRECAUTIONS】

 Do not use after expiration date indicated on the package. Do not use the test if its foil pouchisdamaged. Do not reuse tests.

 This kit contains products of animal origin. Certified knowledge of the origin and/or sanitarystateofthe animals does not totally guarantee the absence of transmissible pathogenic agents. It istherefore,recommended that these products be treated as potentially infectious, and handled observingtheusualsafety precautions (do not ingest or inhale).

 Avoid cross-contamination of specimens by using a new specimen collection container foreachspecimen obtained.

 Read the entire procedure carefully prior to performing any tests.

 Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimensas if they contain infectious agents. Observe established precautions against microbiological hazardsthroughout the procedure and follow the standard procedures for proper disposal of specimens. Wearprotective clothing such as laboratory coats, disposable gloves and eye protection whenspecimensareassayed.

 Buffered Saline contains sodium azide which may react with lead or copper plumbingtoformpotentially explosive metal azides. When disposing of buffered saline or extracted samples, alwaysflush with copious quantities of water to prevent azide build up.

 Do not interchange or mix reagents from different lots.

 Humidity and temperature can adversely affect results.

 The used testing materials should be discarded in accordance with local, state and/orfederalregulations.

【SAMPLE COLLECTION AND STORAGE】

• The CMV IgG/IgM Test is intended for use with human whole blood, serumor plasma specimensonly.

• Only clear, non-hemolyzed specimens are recommended for use with this test. Serumor plasmashouldbeseparated as soon as possible to avoid hemolysis.

• Perform testing immediately after specimen collection. Do not leave specimens at roomtemperatureforprolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For longtermstorage, specimens should be kept below -20°C.

• Bring specimens to room temperature prior to testing. Frozen specimens must be completelythawedandmixed well prior to testing. Avoid repeated freezing and thawing of specimens.

• If specimens are to be shipped, pack them in compliance with all applicable regulationsfortransportation of etiological agents.

• Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.

【OPERATION】
Bring tests, specimens, buffer and/or controls to room temperature (15- 30°C) before use.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with
patient or control identification. For best results, the assay should be performed within one hour.

2. Using the provided disposable pipette, transfer 1 drop of whole blood, serum or plasma specimen to
the specimen well (S) of the cassette, then add 1 drop of buffer and start the timer. Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result window. As the test begins to work, color will migrate across the membrane. 3. Wait for the colored band(s) to appear. The result should be read within 15 minutes.

Do not interpret the result after 20 minutes.

【INTERPRETATION OF RESULTS】

Positive (+) :

IgG Positive: Both IgG test region (IgG) and control region appear color line.

IgM Positive: Both IgM test region (IgM) and control region appear color line.

IgG/IgM Positive: Both test region (IgG and IgM) and control region appear color line.

Negative (-) : Only one color line appears on the control region (C).

Invalid: No visible line at all, or there is a visible line only in the test region and not in the control region. Repeat with a new test kit.