Accu-Tell^® Dengue IgG/IgM/NS1 Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)

Product Description

CATALOG

KEY POINTS

Detection for: IgG and IgM antibodies and non-structural protein antigen to Dengue virus in human whole blood, serum, or plasma

Specimen volume:

Serum or Plasma Specimens: for IgG/IgM Test: 5 μl, for NS1 Test: 75 μL,  or

Whole Blood (Venipuncture/Fingerstick) Specimens: for IgG/IgM Test: 10 μl; for NS1 Test: 75 μL

Reading time: 10 minutes

Relative Sensitivity: for IgG/IgM test: 95.7%; for NS1 test: 95.8%

Relative Specificity: for IgG/IgM test: >99.9%; for NS1 test: 96.2%

Accuracy: for IgG/IgM test: 99.3%; for NS1 test: 96.1%

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/NS1 Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies and non-structural protein antigen to Dengue virus in human whole blood, serum, or plasma as an aid in the diagnosis of Dengue infections.

TEST PROCEDURE

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

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 5µl dropper for Dengue Ab: Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 5μl), and transfer the specimen to the S area (Marked S) of the test cassette, then add 1 drop of buffer (approximately 40μl) to the B area (Marked B) and start the timer. Avoid trapping air bubbles in the specimen well.

To use a 25µl dropper for Dengue Ag: Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75μL) to the specimen area and then start the timer. See illustration below.

For Whole Blood (Venipuncture/Fingerstick) Specimens:

To use a 5µl dropper for Dengue Ab: Hold the dropper vertically, draw the specimen about 1cm above the Fill Line, and transfer 1 drop of whole blood (approximately 10μl) to the S area (Marked S) of the test cassette, then add 1 drop of buffer (approximately 40μl) to the B area (Marked B) and start the timer.

To use a 25ul dropper for Dengue Ag: Hold the dropper vertically and transfer 3 drops whole blood (approximately 75μL) to the specimen area, then add 1 drops of buffer (approximately 40μL), and start the timer. See illustration below.

To use a micropipette for Dengue Ab: Pipette and dispense 10μl of whole blood to the S area (Marked S) of the test cassette, then add 1 drop of buffer (approximately 40μl) to the B area (Marked B) 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/NS1 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^® Rapid Dengue IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) is 95.7% , and the relative specificity is >99.9%,and the relative accuracy is 99.3%, and for the Accu-Tell® Rapid Dengue NS1 Test Cassette (Whole Blood/Serum/Plasma) is 95.8%,and the relative specificity is 96.2%, and the accuracy is 96.1%.

Precision

Intra-Assay

Within-run precision has been determined by using 15 replicates of five specimens: a negative, an IgG positive, an IgM positive and an IgG/IgM dual positive, NS1 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 five specimens: a negative, an IgG positive, an IgM positive and an IgG/IgM dual positive, NS1 positive. Three different lots of ACCU-TELL^® Dengue IgG/IgM/NS1 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/NS1 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           Caffeine: 20 mg/dL

Acetylsalicylic Acid: 20 mg/dL      Gentisic Acid: 20 mg/dL

Ascorbic Acid: 2g/dL                    Albumin: 2 g/dL

Creatin: 200 mg/dL                      Hemoglobin 1000mg/dL

Bilirubin: 1g/dL                             Oxalic Acid: 600mg/dL

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

LIMITATIONS

1.ACCU-TELL^® Dengue IgG/IgM/NS1 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 and NS1 antigen in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in Dengue antibody and NS1 antigen concentration can be determined by this qualitative test.

2. 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 flavivirus characterize the antibodies. 5 The IgM signal may be faint and the cross reaction in the region of IgG line may appear.

3. 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.

4. The continued presence or absence of antibodies and NS1 antigen cannot be used to determine the success or failure of therapy.

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

6. 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.