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

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

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Accu-Tell® CMV IgM Rapid Test Cassette (Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgM antibodies to CMV in serum or plasma to aid in the diagnosis of CMV infection.
Product Description

Product Description

CATALOG

Product NameSpecimenCatalog No.Quantity per boxCertificate
CMV IgM CassetteSerum/PlasmaABT-FT-B211          25T


KEY POINTS

Detection for: Cytomegalovirus in human serum or plasma

Specimen volume: Serum or Plasma specimen: 10μL

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 IgM Rapid Test Cassette (Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of 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 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 draw the serum/plasma up to the Fill Line as shown in illustration below(approximately 10 μL) 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.

CMV IgM(SP) 1.jpg

 

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL® CMV IgM Rapid Test Cassette (Serum/Plasma) was compared with leading commercial EIA CMV tests; the results show that ACCU-TELL® CMV IgM Rapid Test Cassette (Serum/Plasma) has a high sensitivity and specificity.

MethodCMV EIA (IgM)Total Results
ACCU-TELL® CMV IgM Rapid TestCassetteResultsPositiveNegative
Positive31132
Negative2214216
Total Results33215248

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%)

*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 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 IgM 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

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

Ascoribic acid:      20mg/ml                                                     Hemoglobin:1000mg/dl          

Gentistic acid:       20mg/dl                                                      Oxalic acid:      60mg/dl                  

Bilirubin:           1000mg/dl                                                      Uric acid:         20mg/ml

Acetoaminophen:20mg/dl                                                       Aspirin:             20mg/dl             

Methanol:                   10%                                                        Creatine:        200mg/dl               

Albumin:         2000mg/dl                                                        Caffeine:          20mg/dl

None of the substances at the concentration tested interfered in the assay.

 

LIMITATIONS

1. ACCU-TELL® CMV IgM Rapid Test Cassette (Serum/Plasma) is for in vitro diagnostic use only. This test should be used for detection of IgM antibodies to CMV in serum or plasma specimens. Neither the quantitative value nor the rate of increase in the concentration of IgM antibodies to CMV can be determined by this qualitative test.

2. ACCU-TELL® CMV IgM Rapid Test Cassette (Serum/Plasma) will only indicate the presence of IgM 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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