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Products

Norovirus Test
Norovirus Feces Test Cassette

Catalog No.          Product Name               

ABT-IDT-B256       Norovirus Feces Test Cassette

INTENDED USE

ACCU-TELL® Rapid Norovirus Test Cassette (Feces) is a rapid chromatographic immunoassay for the qualitative detection of Norovirus in human feces specimens to aid in the diagnosis of Norovirus infection.


PERFORMANCE CHARACTERISTICS

Clinical Sensitivity, Specificity and Accuracy

The performance of ACCU-TELL® Rapid Norovirus Test Cassette (Feces) has been evaluated with 70 clinical specimens collected from children and young adults in comparison with RT-PCR method. The results show that the relative sensitivity of ACCU-TELL® Rapid Norovirus Test Cassette (Feces) is 95.65% and the relative specificity is 91.67%.

ACCU-TELL® Rapid Norovirus Test Cassette (Feces) vs. RT-PCR

Method

RT-PCR

Total Results

ACCU-TELL® Rapid Norovirus Test Cassette (Feces)

Results

Positive

Negative

Positive

44

2

46

Negative

2

22

24

Total Results

46

24

70

 Relative Sensitivity: 95.65% (95%CI:*85.16%-99.57%)        

Relative Specificity: 91.67% (95%CI:*73.00%-98.97%)

Relative Accuracy: 94.29% (95%CI:*86.01%-98.42%)

*Confidence Intervals

Precision

Intra-Assay

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

Inter-Assay

Between-run precision has been determined by 10 independent assays on the same four specimens: a negative, a low positive, a medium positive and a high positive. The specimens were correctly identified >99% of the time.

Cross-Reactivity

Cross reactivity with following organisms has been studied at 10 x 109organisms/ml. The following organisms were found negative when tested with ACCU-TELL® Rapid Norovirus Test Cassette (Feces).

Staphylococcus aureus

Neisseria gonorrhea

Acinetobacter spp

Pseudomonas aeruginosa

Group   B Streptococcus

Salmonella choleraesius

Enterococcus faecalis

Proteus vulgaris

Gardnerella vaginalis

Group C Streptococcus

Enterococcus faecium

Acinetobacter calcoaceticus

Klebsiella pneumoniae

Proteus mirabilis

E.coli

Branhamella catarrhalis

Candida albicans

Chlamydia trachomatis

Hemophilus influenzae

Neisseria meningitides

 

 

LIMITATIONS

  1. This test should be used for detection of Norovirus antigens in human stool only.

  2. ACCU-TELL® Rapid Norovirus Test Cassette (Feces) only indicates the presence of Norovirus antigen in the specimen and should not be used as the sole criteria for the diagnosis of Norovirus infection.

  3. Stool sample from infant under one year old can produce a false positive result.

  4. As with all diagnostic tests, result must be considered together with other clinical information available to the physician.

  5. 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 Norovirus infection.