Accu-Tell® CMV IgG Rapid Test Cassette (Serum/Plasma)
Product Description
CATALOG
Product Name | Specimen | Catalog No. | Quantity per box | Certificate |
CMV IgG Cassette | Serum/Plasma | ABT-FT-B230 | 25T |
KEY POINTS
Detection for: IgG antibodies to Cytomegalovirus in human serum or plasma
Specimen volume: Serum or Plasma specimen: 10μL
Reading time: 15 minutes
Sensitivity: 99.1% (95%CI*: 96.6%~99.9%)
Specificity: 97.3% (95%CI*: 85.8%~99.9%)
Accuracy: 98.8 % (95%CI*: 96.5%~99.8%)
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 Rapid Test Cassette (Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG 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 as soon as possible. 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 drop of serum or plasma (Approx.10μL) and 2 drops of buffer (approx.80μL) 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 20 minutes.
PERFORMANCE CHARACTERISTICS
Sensitivity and Specificity
ACCU-TELL® CMV IgG Rapid Test Cassette (Serum/Plasma) was compared with leading commercial EIA CMV tests; the results show that ACCU-TELL® CMV IgG Rapid Test Cassette (Serum/Plasma) has a high sensitivity and specificity.
Method | CMV EIA (IgG) | Total Results | ||
ACCU-TELL® CMV IgG Rapid Test Cassette (Serum/Plasma) | Results | Positive | Negative | |
Positive | 210 | 1 | 211 | |
Negative | 2 | 36 | 38 | |
Total Results | 212 | 37 | 249 |
Sensitivity: 99.1% (95%CI*: 96.6%~99.9%)
Specificity: 97.3% (95%CI*: 85.8%~99.9%)
Accuracy: 98.8 % (95%CI*: 96.5%~99.8%)
*Confidence Interval
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 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 Rapid Test Cassette (Serum/Plasma) has been tested for HAV, HBV, HCV, HIV, RF, Syphilis, H.Pylori, Rubella, TOXO, HSV 1/2 positive specimens. The results showed no cross-reactivity.
Interfering Substances
ACCU-TELL® CMV IgG Rapid Test Cassette (Serum/Plasma) has been tested and no interference was observed in specimens containing 20mg/ml Human Albumin, 0.6mg/ml Bilirubin, 10mg/ml Hemoglobin and 5mg/ml Triglycerides.
The following compounds have also been tested using ACCU-TELL® CMV IgG Rapid Test Cassette (Serum/Plasma) and no interference was observed.
Acetaminophen: 20mg/dL Caffeine: 20mg/dL
Aspirin: 20mg/dL Gentisic Acid: 20mg/dL
Ethanol: 1% Creatine: 200mg/dL
Ascorbic Acid: 20mg/dL Uric acid: 20mg/ml
Oxalic acid: 60mg/dL
LIMITATIONS
1. ACCU-TELL® CMV IgG Rapid Test Cassette (Serum/Plasma) is for in vitro diagnostic use only. This test should be used for detection of IgG antibodies to CMV in serum or plasma specimens. Neither the quantitative value nor the rate of increase in the concentration of IgG antibodies to CMV can be determined by this qualitative test.
2. ACCU-TELL® CMV IgG Rapid Test Cassette (Serum/Plasma) will only indicate the presence of IgG antibodies to CMV in the specimen and should not be used as the sole criteria for the diagnosis of CMV infections.
3. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.
4. If the test result is negative and clinical symptoms persist, additional follow-up testing using other clinical methods is suggested. A negative result at any time does not preclude the possibility of CMV infection.
Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.
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