Accu-Tell^® CMV IgG/IgM Rapid Test Cassette (Serum/Plasma)

Product Description

CATALOG

KEY POINTS

Detection for: IgG/IgM antibodies to Cytomegalovirus in human serum or plasma

Specimen volume: Serum or Plasma specimen: 25μL

Reading time: 15 minutes

Sensitivity: 93.9% (95%CI*: 79.8%~99.3%)
Specificity: 99.5% (95%CI*: 97.4%~99.9%)

Accuracy: 98.8 % (95%CI*: 96.5%~99.7%)

INTRODUCTION

Cytomegalovirus is a herpes virus. It is a leading etiological agent for congenital abnormalities and complications among those who receive massive blood transfusions and immunosuppressive therapy. About half of pregnant women who contract a primary infection spread the disease to their fetus. Infection during pregnancy may cause mental retardation, blindness, and/or deafness of the fetus.

INTENDED USE

ACCU-TELL^® CMV IgG/IgM Rapid Test Cassette (Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to CMV in serum or plasma to aid in the diagnosis of CMV infection.

TEST PROCEDURE

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour. Best results will be obtained if the assay is performed within one hour.

2. Place the test cassette on a clean and level surface. Hold the dropper vertically and transfer 1 drops of serum or plasma (Approx.25μl) and 2 drops of buffer to the specimen well of the test cassette. Avoid trapping air bubbles in the specimen well. See the illustration below.

3. Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret results after 20minutes.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

A clinical evaluation was conducted comparing the results obtained using ACCU-TELL^® CMV IgG/IgM Rapid Test Cassette (Serum/Plasma) to CMV IgG/IgM ELISA Testing. The study included 412 IgG specimens and 248 IgM specimens, and about the IgG specimen both assays identified 212 negative and 200 positive results, about the IgM specimen both assays identified 216 negative and 32 positive results.

IgG Results

IgM Results

Precision

Intra-Assay

Within-run precision has been determined by using 10 replicates of three specimens: a negative, a low positive, and a high positive. The negative, low positive, and high positive values were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 10 independent assays on the same three specimens: a negative, a low positive, and a high positive. Three different lots of ACCU-TELL^® CMV IgG/IgM Rapid Test Cassette (Serum/Plasma) have been tested over a 3-day period using negative, low positive, and high positive specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity

ACCU-TELL^® CMV IgG/IgM Rapid Test Cassette (Serum/Plasma) has been tested for HBsAg, HBsAb, HbeAg, HBeAb, HBcAb, HCV, HIV, Syphilis, H. Pylori, HSV and Rubella positive specimens. The results showed no cross-reactivity.

Interfering Substances

The following potentially interfering substances were added to CMV negative and positive specimens.

Acetaminophen:           20mg/dl                                    Caffeine:                       20mg/dl

Hemoglobin:                      1g/dl                                    Oxalic acid:                   60mg/dl

Bilirubin:                            1g/dL                                    Uric acid:                      20mg/ml

Ascorbic Acid:              20mg/ml                                    Aspirin:                          20mg/dl 

Methanol:                           10%                                    Gentisic Acid:                 20mg/dl

Creatine:                      200mg/dl                                   Albumin:                             2g/dl

LIMITATIONS

1. The Assay Procedure and the Test Result Interpretation must be followed closely when testing the presence of antibodies to CMV in serum or plasma from individual subjects. Failure to follow the procedure may give inaccurate results.

2. ACCU-TELL^® CMV IgG/IgM Rapid Test Cassette (Serum/Plasma) is limited to the qualitative detection of the antibodies to CMV in human serum or plasma. The intensity of the test band does not linear correlation with the antibody titer in the specimen.

3. A negative result for an individual subject indicates absence of detectable CMV antibodies. However, a negative test result does not preclude the possibility of exposure to or infection with CMV.

4. A negative result can occur if the quantity of the CMV antibodies present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected

5. Some specimens containing unusually high titer of heterophile antibodies or rheumatoid factor may affect expected results.

6. The results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings.

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.