ATFirst™ · Malaria and dengue rapid tests
ATFirst™ Dengue IgG/IgM Rapid Test
A lateral flow test device with separate IgG and IgM test lines for the qualitative detection of antibodies to dengue virus in whole blood, serum or plasma. Results are read at 10 minutes.
- Professional use
- Result in 10 minutes
- Whole blood, serum or plasma
- Separate IgG and IgM lines
Intended use
The ATFirst™ dengue IgG IgM rapid test is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to dengue virus in human whole blood, serum or plasma. It is intended for professional use as an aid in the diagnosis of primary and secondary dengue infections.
The test detects antibodies only. The insert states that it should not be used as the sole criterion for the diagnosis of dengue, and a clinician must interpret every result with other clinical and laboratory findings.
First Diagnostic™ Corporation brands and distributes this test within its catalog of rapid tests.
Specifications
| Brand | ATFirst™ |
|---|---|
| Reference | IDE-402 (insert file reference); insert number 1150329203 |
| Format | Lateral flow test device with specimen well (S), IgG line (T1), IgM line (T2) and control line (C) |
| Analyte / target | IgG and IgM antibodies to dengue virus |
| Specimen | Whole blood (venipuncture or fingerstick), serum or plasma |
| Sample volume | Serum or plasma: approximately 5 µL. Whole blood: approximately 10 µL. Then 3 drops of buffer (approximately 90 µL). |
| Time to result | Read at 10 minutes |
| Read window | Do not interpret the result after 20 minutes |
| Kit contents | Test devices, droppers, buffer, package insert |
| Storage | 2–30 °C in the sealed pouch; do not freeze |
| Intended user | Healthcare professionals |
| Regulatory | Documentation available on request |
| Insert document | Number 1150329203, effective date 2006-01 |
How the dengue IgG IgM rapid test works
The device is a membrane-based lateral flow test with an IgG component and an IgM component. Anti-human IgG is coated in test line region 1 (T1). The specimen reacts with dengue antigen-coated particles, and IgG antibodies to dengue form a colored line at T1.
For IgM, the specimen also reacts with ligand anti-human IgM. Dengue IgM antibodies bind this ligand and the antigen-coated particles, and the complex is captured by anti-ligand coated in test line region 2 (T2).
Test procedure at a glance
- Bring to room temperature. Allow the test device, specimen and buffer to reach room temperature (15–30 °C). Bring the pouch to room temperature before opening it, then place the device on a clean and level surface.
- Add the specimen. Serum or plasma: hold the dropper vertically, draw the specimen up to the Fill Line (approximately 5 µL) and transfer it to the specimen well (S). Whole blood: draw the specimen 0.5–1 cm above the Fill Line and transfer 1 drop (approximately 10 µL) to the specimen well (S), or dispense 10 µL with a micropipette.
- Add the buffer. Add 3 drops of buffer (approximately 90 µL) and start the timer.
- Read the result. Read results at 10 minutes. Do not interpret the result after 20 minutes.
This summary does not replace the instructions for use supplied with the kit.
Reading results
The control line of this test behaves differently from that of most lateral flow tests. The line in the control region (C) starts red and must change completely to blue; this confirms sufficient buffer volume and adequate membrane wicking.
- IgG positive: the control line turns blue and a colored line appears at T1. The insert describes this as probably indicative of secondary dengue infection.
- IgM positive: the control line turns blue and a colored line appears at T2, indicative of primary dengue infection.
- IgG and IgM positive: the control line turns blue and lines appear at T1 and T2, indicative of secondary dengue infection.
- Negative: the control line turns blue and no line appears at T1 or T2.
- Invalid: the control line is still completely or partially red. Repeat with a new device.
Any shade of color at T1 or T2 should be considered positive.
Performance
Dengue IgG/IgM Rapid Test Device compared with a leading commercial dengue ELISA test, using specimens from symptomatic and asymptomatic individuals, as printed in the product insert.
| Dengue infection (by ELISA) | Result | IgM | IgG |
|---|---|---|---|
| Primary infection | Positive | 14 | 0 |
| Primary infection | Negative | 3 | 17 |
| Primary infection | Total | 17 | 17 |
| Primary infection | Relative sensitivity | 82.4% | 0% |
| Secondary infection | Positive | 39 | 55 |
| Secondary infection | Negative | 16 | 0 |
| Secondary infection | Total | 55 | 55 |
| Secondary infection | Relative sensitivity | 70.9% | >99.0% |
| Non-dengue infection | Positive | 0 | 0 |
| Non-dengue infection | Negative | 378 | 378 |
| Non-dengue infection | Total | 378 | 378 |
| Non-dengue infection | Relative specificity | >99.0% | >99.0% |
For primary and secondary infection, the insert states an overall sensitivity of 95.8%, an overall specificity of >99.0% and an overall accuracy of 99.3%. Source: product insert.
Limitations
- In the early onset of fever, anti-dengue IgM concentrations may be below detectable levels.
- In secondary infection the IgM signal may be faint, and a cross reaction in the region of the IgG line may appear.
- Serological cross-reactivity across the flavivirus group (dengue 1, 2, 3 and 4, St. Louis encephalitis, West Nile, Japanese encephalitis and yellow fever viruses) is common. Positive results should be confirmed by other means.
- The test is qualitative, and the continued presence or absence of antibodies cannot be used to determine the success or failure of therapy.
- Results from immunosuppressed patients should be interpreted with caution.
- A negative result does not at any time preclude the possibility of dengue infection.
Downloads
The package insert supplied with the kit is the reference document for this test.
Frequently asked questions
How long can specimens be kept?
Serum and plasma may be stored at 2–8 °C for up to 3 days, or below -20 °C for long-term storage. Venipuncture whole blood should be stored at 2–8 °C if the test is to be run within 2 days and must not be frozen. Fingerstick whole blood should be tested immediately.
How should the kit be stored?
As packaged in the sealed pouch, at room temperature or refrigerated (2–30 °C). Do not freeze.
What does the kit contain?
Test devices, droppers, buffer and the package insert. Lancets and a micropipette are not provided. The insert does not state the pack size; confirm it on your quotation.
What documentation is available?
The package insert is listed with our other product inserts and instructions for use. Regulatory documentation is available on request.
How do distributors order?
Complete the distributor application or email sales@firstdiagnostic.com with the reference IDE-402 and the quantity you need.
Related rapid tests
- Malaria and dengue rapid tests — The full tropical fever category.
- ATFirst™ Malaria P.f. rapid test — Detects P. falciparum HRP-II antigen in whole blood.
- ATFirst™ Flu A & B rapid test — Detects influenza A and B nucleoprotein antigens in nasal and nasopharyngeal specimens.
- ATFirst™ Rubella IgG/IgM combo rapid test — Detects IgG and IgM antibodies to rubella virus in whole blood, serum or plasma.
- Lateral flow tests explained — How lateral flow tests work and where they are used.
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Regulatory status: Products shown on this website are for professional in vitro diagnostic use. They are not cleared, approved or authorized by the U.S. Food and Drug Administration and are not offered for sale in the United States. Product availability and regulatory status vary by country; contact us for the status in your market.