Accu-Tell^® Adenovirus Cassette (Feces)

Product Description

CATALOG

KEY POINTS

Detection for: Adenovirus in human feces specimens；

Reading time: 10 minutes；

Relative Sensitivity: >99.9%；

Relative Specificity: 99.5%；

Relative Accuracy: 99.6%.

INTRODUCTION

Acute diarrheal disease in young children is a major cause of morbidity worldwide and is a leading cause of mortality in developing countries. Research has shown that enteric adenoviruses, primarily Ad40 and Ad41, are a leading cause of diarrhea in many of these children, second only to the rotaviruses. These viral pathogens have been isolated throughout the world, and can cause diarrhea in children year round. Infections are most frequently seen in children less than two years of age, but have been found in patients of all ages. Further studies indicate that adenoviruses are associated with 4-15% of all hospitalized cases of viral gastroenteritis.

INTENDED USE

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

TEST PROCEDURE

Allow the test, specimen, buffer, and/or controls to reach room temperature (15-30°C) prior to testing.

1.   To collect fecal specimens:

Collect sufficient quantity of feces (1-2 mL or 1-2  g) in a clean, dry specimen collection container to obtain enough virus particles. Best results will be obtained if the assay is performed within 6 hours after collection. Specimen collected may be stored for 3 days at 2-8°C if not tested within 6 hours. For long term storage, specimens should be kept below  -20°C.

2.   To process fecal specimens:

·  For Solid Specimens:

Unscrew the cap of the specimen collection tube， then randomly stab the specimen collection applicator into the fecal specimen in at least 3 different sites to collect approximately 50 mg of feces (equivalent to 1/4 of a pea). Do not scoop the fecal specimen.

·  For Liquid Specimens:

Hold the dropper vertically, aspirate fecal specimens, and then transfer 2 drops (approximately 50 µL) into the specimen collection tube containing the extraction buffer.

Tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer.

3.      Bring the pouch to room temperature before opening it. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.

4.      Hold the specimen collection tube upright and unscrew the tip of the specimen collection tube. Invert the specimen collection tube and transfer 2 full drops of the extracted specimen (approximately 80 mL) to the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration above.

5.      Read the results at 10 minutes after dispensing the specimen. Do not read results after 20 minutes.

Note: If the specimen does not migrate (presence of particles), centrifuge the diluted sample contained in the extraction buffer vial. Collect 80 µL of supernatant, dispense into the specimen well (S). Start the timer and continue from step 5 onwards in the above instructions for use.

PERFORMANCE CHARACTERISTICS

Clinical Sensitivity, Specificity and Accuracy

The performance of ACCU-TELL^® Adenovirus Cassette (Feces) has been evaluated with 244 clinical specimens collected from children and young adults in comparison with latex agglutination method. The results show that the relative sensitivity of ACCU-TELL® Adenovirus Cassette (Feces) is >99.9% and the relative specificity is 99.5%.

Adenovirus Rapid Test Cassette vs. Latex Agglutination

Relative Sensitivity: >99.9% (95.1%-100.0%)* 

Relative Specificity: 99.5% (97.0%-100.0%)*

Relative Accuracy: 99.6% (97.7%-100.0%)*                        

*95% Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 15 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 15 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 10⁹ organisms/ml. The following organisms were found negative when tested with ACCU-TELL^® Adenovirus 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.      ACCU-TELL^® Adenovirus Cassette (Feces) is for in vitro diagnostic use only. The test should be used for the detection of Adenovirus in human feces specimens only. Neither the quantitative value nor the rate of increase in adenovirus concentration can be determined by this qualitative test.

2.   ACCU-TELL^® Adenovirus Cassette (Feces) will only indicate the presence of adenovirus in the specimen and should not be used as the sole criteria for the conforming adenovirus to be etiological agent for diarrhea.

3.   As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.

4.   If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of adenovirus infection with low concentration of virus particles.

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