ATFirst™ · ToRCH and prenatal rapid tests
ATFirst™ Rubella IgG/IgM Combo Rapid Test Cassette
A rubella IgG/IgM rapid test for the qualitative detection of IgG and IgM antibodies to rubella in whole blood, serum or plasma, read at 15 minutes. For professional in vitro diagnostic use.
- Professional use
- Whole blood, serum or plasma
- Read at 15 minutes
- CE marked
Intended use
The ATFirst™ Rubella IgG/IgM Combo Rapid Test Cassette from First Diagnostic™ Corporation is a rubella IgG IgM rapid test: a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to rubella in whole blood, serum or plasma. It is for professional in vitro diagnostic use only.
The test aids in the diagnosis of rubella infection. Results must be considered by a clinician with other clinical and laboratory findings. It belongs to our ToRCH and prenatal rapid tests in the rapid tests catalog.
Specifications
| Brand | ATFirst™ |
|---|---|
| Catalog number | REF IRGM-425 (catalog 85226400150) |
| Format | Lateral flow cassette with two strips (IgG and IgM), each with its own sample well, test line and control line (C) |
| Target | IgG and IgM antibodies to rubella, qualitative |
| Specimen | Whole blood (fingerstick or venipuncture), serum or plasma |
| Sample volume | 1 full drop of specimen (approx. 20 µL) and 2 drops of buffer (approximately 80 µL) to each sample well |
| Time to result | Read at 15 minutes |
| Read window | Do not interpret after 20 minutes |
| Kit contents | Test cassettes; droppers; buffer; package insert |
| Required but not provided | Specimen collection containers; centrifuge (plasma only); timer |
| Storage | 2–30 °C in the sealed pouch. Do not freeze. |
| Tests per kit | See kit label |
| Intended user | Healthcare professionals |
| Regulatory | CE marked (as shown on the product insert) |
| Insert document | Package insert number 145403301, effective date 2017-02-10 |
How the rubella IgG/IgM rapid test works
The cassette is an antibody-detection lateral flow immunoassay. Rubella antigen is coated in the test line regions. During testing, the specimen reacts with particles coated with mouse anti-human IgG or goat anti-human IgM.
The mixture migrates along the membrane by capillary action and reacts with the rubella antigen, forming a colored line in the test line region when rubella antibodies are present. A colored control line on each strip shows that the proper volume of specimen was added and that membrane wicking occurred. Our guide to lateral flow tests explains the principle.
Test procedure at a glance
Summarized from the directions for use in the insert.
- Prepare. Allow the test, specimen and buffer to reach room temperature (15–30 °C). Remove the cassette from the sealed pouch, place it on a clean, level surface and use it within one hour.
- Add the specimen. Hold the dropper vertically and transfer 1 full drop (approx. 20 µL) of specimen to each sample well.
- Add buffer. Add 2 drops of buffer (approximately 80 µL) to each sample well and start the timer.
- Read the result. Read at 15 minutes. Do not interpret results after 20 minutes.
This summary does not replace the instructions for use supplied with the kit.
Reading results
Read the IgG strip and the IgM strip separately. Each has its own control line.
- Positive: two colored lines appear, one in the control line region (C) and one in the test line region. Any shade of color in the test line region is read as positive.
- Negative: one colored line appears in the control line region (C) and no line appears in the test line region.
- Invalid: the control line fails to appear. Insufficient specimen volume or incorrect technique are the most likely reasons; repeat with a new test.
Performance
IgM strip compared with a commercial rubella EIA (IgM), as printed in the product insert
| Rubella IgM rapid test result | EIA positive | EIA negative | Total |
|---|---|---|---|
| Positive | 57 | 3 | 60 |
| Negative | 4 | 307 | 311 |
| Total | 61 | 310 | 371 |
According to the product insert: relative sensitivity 93.4%, relative specificity 99.0%, overall accuracy 98.1%. Source: product insert (number 145403301).
IgG strip compared with a commercial rubella EIA (IgG), as printed in the product insert
| Rubella IgG rapid test result | EIA positive | EIA negative | Total |
|---|---|---|---|
| Positive | 56 | 4 | 60 |
| Negative | 5 | 306 | 311 |
| Total | 61 | 310 | 371 |
According to the product insert: relative sensitivity 91.8%, relative specificity 98.7%, overall accuracy 97.6%. Source: product insert (number 145403301).
According to the product insert, no cross-reactivity was seen with HAV, HBV, HCV, HIV, RF, syphilis, H. pylori, CMV, TOXO and HSV 1/2 positive specimens. The full text is on the product inserts page.
Limitations
- The test is qualitative. Neither the quantitative value nor the rate of increase in the concentration of IgM and IgG antibodies to rubella can be determined.
- It indicates only the presence of IgM or IgG antibodies to rubella and should not be used as the sole criterion for the diagnosis of rubella infection.
- A negative result at any time does not preclude the possibility of rubella infection. If symptoms persist, follow-up testing using other clinical methods is suggested.
- General note, not from the insert: IgG antibodies can reflect past infection or vaccination, and results that affect clinical management should be confirmed by laboratory methods under local guidelines.
Downloads
The package insert contains the full instructions for use, specimen handling and performance characteristics.
Frequently asked questions
Which specimens can be used?
Whole blood, serum or plasma. Test fingerstick whole blood immediately. Venous whole blood may be stored at 2–8 °C if the test is run within 2 days of collection.
Does the test measure the level of rubella antibodies?
No. It is qualitative and reports only whether IgG or IgM antibodies to rubella are detected.
How are kits stored, and are controls included?
Store in the sealed pouch at room temperature or refrigerated (2–30 °C); do not freeze. Each strip has an internal control line. Control standards are not supplied with the kit.
How can we order or become a distributor?
Email sales@firstdiagnostic.com for a quotation, or complete the distributor application. First Diagnostic supplies customers outside the United States.
Related rapid tests
- ToRCH and prenatal rapid tests — Rubella, CMV, HSV and ToRCH tests in the ATFirst™ range.
- ATFirst™ ToRCH IgM rapid test — IgM panel for Toxoplasma, rubella, CMV and HSV.
- ATFirst™ CMV IgM rapid test — Cytomegalovirus IgM in serum or plasma.
- ATFirst™ HSV 1/2 IgM rapid test — Herpes simplex virus IgM in serum or plasma.
- Lateral flow tests explained — How lateral flow cassettes work.
Request a quote for the ATFirst™ Rubella IgG/IgM rapid test
First Diagnostic brands and distributes lateral flow rapid tests made by established IVD manufacturers. Tell us your market and volume, and we will reply with pricing and documentation.
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.