Accu-Tell® Dengue IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
Product Description
CATALOG
Product Name | Specimen | Catalog No. | Quantity per box | Certificate |
Dengue IgG/IgM Cassette | Whole Blood/Serum/Plasma | ABT-IDT-B97 | 20T | CE |
KEY POINTS
Detection for: Antibodies (IgG and IgM) to Dengue virus in whole blood, serum, or plasma.
Specimen volume: Serum or Plasma Specimen: 5μl
Venipuncture or Fingerstick Whole Blood Specimen: 10μl
Reading time: 10 minutes
Relative sensitivity: 95.7% (95%CI*: 88.0%~99.1%);
Relative specificity: 99.9% (95%CI*: 99.1%~100.0%);
Accuracy: 99.3% (95%CI*: 97.9%~99.8%).
INTRODUCTION
Dengue is a flavivirus, transmitted by Aedes aegypti and Aedes albopictus mosquitoes. It is widely distributed throughout the tropical and subtropical areas of the world, and causes up to 100 million infections annually. Classic Dengue infection is characterized by a sudden onset of fever, intense headache, myalgia, arthralgia and rash.
INTENDED USE
ACCU-TELL® Dengue IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Dengue virus in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary Dengue infections.
TEST PROCEDURE
1. Bring the pouch to room temperature before opening. Remove the test cassette from the sealed pouch and use it within one hour.
2. Place the test cassette on a clean and level surface.
For Serum or Plasma Specimens:
To use a dropper: Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 5 μl), and transfer the specimen to the specimen well of the test cassette, then add 1 drop of buffer (approximately 40ul) and start the timer. Avoid trapping air bubbles in the specimen well
To use a micropipette: Pipette and dispense 5 µl of specimen to the specimen well of the test cassette, then add 1 drop of buffer (approximately 40 µl) and start the timer.
For Whole Blood (Venipuncture/Fingerstick) Specimens:
To use a dropper: Hold the dropper vertically, draw the specimen about 1cm above the Fill Line, and transfer 1 drop of whole blood (approximately 10 µl) to the specimen well of the test cassette, then add 1 drop of buffer (approximately 40 ul) and start the timer.
To use a micropipette: Pipette and dispense 10 µl of whole blood to the specimen well of the test cassette, then add 1 drop of buffer (approximately 40 µl) and start the timer.
3. Wait for the colored line(s) to appear. The test result should be read at 10 minutes. Do not interpret the result after 20 minutes.
PERFORMANCE CHARACTERISTICS
Sensitivity and Specificity
ACCU-TELL® Dengue IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) has been evaluated with specimens obtained from a population of symptomatic and asymptomatic individuals. Results were confirmed by a leading commercial Dengue ELISA test.
The results show that the overall relative sensitivity for the primary and secondary infection of ACCU-TELL® Dengue IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is 95.7%, and the relative specificity is >99.9%,and the relative accuracy is 99.3%.
Dengue Primary Infection for IgM/IgG test results
Method | ELISA | ||||
ACCU-TELL® Dengue IgG/IgM Rapid Test Cassette | Results | Positive | negative | ||
IgM | IgG | ||||
Positive | IgM | 15 | 0 | 0 | |
IgG | 3 | 0 | 0 | ||
Negative | 0 | 0 | 0 | ||
Relative Sensitivity | 83.3% | / | / |
Dengue Secondary Infection for IgM/IgG test results
Method | ELISA | ||||
ACCU-TELL® Dengue IgG/IgM Rapid Test Cassette | Results | Positive | negative | ||
IgM | IgG | ||||
Positive | IgM | 37 | 0 | 0 | |
IgG | 15 | 52 | 0 | ||
Negative | 0 | 0 | 0 | ||
Relative Sensitivity | 71.2% | >99.9% | / |
Non-Dengue Infection for IgM/IgG test results
Method | ELISA | ||||
ACCU-TELL®Dengue IgG/IgMRapid Test Cassette | Results | Positive | negative | ||
IgM | IgG | ||||
Positive | IgM | 0 | 0 | 0 | |
IgG | 0 | 0 | 0 | ||
Negative | 0 | 0 | 338 | ||
Relative Specificity | / | / | >99.9% |
Relative sensitivity: (15+52)/ (18+52) =95.7% (95%CI*: 88.0%~99.1%);
Relative specificity: 338/338>99.9% (95%CI*: 99.1%~100.0%);
Accuracy: (15+52+338)/ (18+52+338) =99.3% (95%CI*: 97.9%~99.8%).
*Confidence Intervals
Precision
Intra-Assay
Within-run precision has been determined by using 15 replicates of four specimens: a negative, an IgG positive, an IgM positive and an IgG/IgM dual 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, an IgG positive, an IgM positive and an IgG/IgM dual positive. Three different lots of ACCU-TELL® Dengue IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) have been tested using these specimens. The specimens were correctly identified >99% of the time.
Cross-reactivity
ACCU-TELL® Dengue IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, Syphilis, HIV, HCV, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity.
Interfering Substances
The following potentially interfering substances were added to Dengue negative and positive specimens.
Acetaminophen: 20 mg/dL Acetylsalicylic Acid: 20 mg/dL
Ascorbic Acid: 2g/dL Bilirubin: 1g/dL
Creatin: 200 mg/dL Caffeine: 20 mg/dL
Gentisic Acid: 20 mg/dL Albumin: 2 g/dL
Hemoglobin 1000mg/dL Oxalic Acid: 600mg/dL
None of the substances at the concentration tested interfered in the assay.
LIMITATIONS
1. ACCU-TELL® Dengue IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of Dengue antibodies in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in Dengue antibody concentration can be determined by this qualitative test.
2. ACCU-TELL® Dengue IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) will only indicate the presence of Dengue antibodies in the specimen and should not be used as the sole criteria for the diagnosis of Dengue.
3. In the early onset of fever, anti-Dengue IgM concentrations may be below detectable levels. For primary infection, an IgM antibody-capture enzyme-linked immunosorbent assay (MAC-ELISA) showed that 80% of the Dengue patients tested exhibited detectable levels of IgM antibody by the fifth day after infection, and 99% of the patients tested IgM positive by day 10. It is recommended that patients be tested within this time. For the secondary infection, a low molar fraction of anti-Dengue IgM and a high molar fraction of IgG that is broadly reactive to flaviviruses characterize the antibodies. 5 The IgM signal may be faint and the cross reaction in the region of IgG line may appear.
4. Serological cross-reactivity across the flavivirus group (Dengue 1, 2, 3 & 4, St. Louis encephalitis, West Nile virus, Japanese encephalitis and yellow fever viruses) is common.6,7,8 Positive results should be confirmed by other means.
5. The continued presence or absence of antibodies cannot be used to determine the success or failure of therapy.
6. Results from immunosuppressed patients should be interpreted with caution.
7. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
8. 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 Dengue 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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