ATFirst™ · Tropical fever rapid tests
ATFirst™ Malaria P.f. Rapid Test Cassette
A malaria rapid test for the qualitative detection of Plasmodium falciparum (P.f.) antigen in fingerstick or venous whole blood, read at 10 minutes. For professional in vitro diagnostic use.
- Professional use
- Whole blood
- Read at 10 minutes
- CE marked
Intended use
The ATFirst™ Malaria P.f. Rapid Test Cassette from First Diagnostic™ Corporation is a malaria rapid test: a rapid chromatographic immunoassay for the qualitative detection of circulating Plasmodium falciparum in whole blood. It detects the P.f. antigen HRP-II and is for professional in vitro diagnostic use only.
The result is an aid to diagnosis and must be interpreted with other clinical information available to the physician. The product belongs to our malaria and dengue rapid tests in the rapid tests catalog.
Specifications
| Brand | ATFirst™ |
|---|---|
| Catalog number | REF IMA-402 (catalog 85226400090) |
| Format | Lateral flow cassette with two lines: control (C) and P.f. test line (T) |
| Target | Plasmodium falciparum HRP-II antigen, qualitative |
| Specimen | Whole blood only (fingerstick or venipuncture) |
| Sample volume | 10 µL of whole blood, followed by 3 drops of buffer (approximately 180 µL) |
| Time to result | Read at 10 minutes |
| Read window | Do not interpret after 20 minutes |
| Kit contents | Test cassettes; disposable specimen droppers; buffer; package insert |
| Required but not provided | Specimen collection containers; lancets (fingerstick only); timer; pipette and disposable tips (optional) |
| 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 145019601, effective date 2015-09-08 |
How the malaria rapid test works
The cassette is a qualitative, membrane-based immunoassay that captures antigen. It contains anti-HRP-II antibodies conjugated to colloidal gold, and the membrane is pre-coated with anti-HRP-II antibodies at the test line.
The whole blood specimen reacts with the conjugate and migrates along the membrane by capillary action. If the specimen contains P.f. antigen, a colored line appears in the test region. A colored control line confirms 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). Bring the pouch to room temperature before opening it and use the cassette as soon as possible.
- Collect the specimen. Use fingerstick or venipuncture whole blood. Test fingerstick blood immediately. Venous blood may be stored at 2–8 °C if the test is run within 2 days of collection.
- Add the specimen. Place the cassette on a clean, level surface. Transfer 10 µL of whole blood to the specimen well with a pipette, or with the supplied dropper filled to the Fill Line.
- Add buffer. Add 3 drops of buffer (approximately 180 µL) and start the timer.
- Read the result. Read 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
- Positive: two lines appear, one in the control line region (C) and one in the test line region (T). 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 (T).
- Invalid: the control line fails to appear. Insufficient specimen volume or incorrect technique are the most likely reasons; repeat with a new test.
Performance
Comparison with blood smear microscopy (thick or thin blood smears) on clinical samples, as printed in the product insert
| ATFirst™ Malaria P.f. result | Microscopy positive | Microscopy negative | Total |
|---|---|---|---|
| Positive | 90 | 0 | 90 |
| Negative | 0 | 467 | 467 |
| Total | 90 | 467 | 557 |
Source: product insert (number 145019601).
Relative performance against blood smear microscopy, according to the product insert
| Measure | Printed value | 95% confidence interval |
|---|---|---|
| Relative sensitivity | >99.9% | 96.7%–100.0% |
| Relative specificity | >99.9% | 99.4%–100.0% |
| Accuracy | >99.9% | 99.5%–100.0% |
Source: product insert (number 145019601). Figures are relative to the comparator method in the study reported in the insert.
According to the product insert, no cross-reactivity was seen with HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, syphilis, HIV, HCV, H. pylori, MONO, CMV, rubella and TOXO positive specimens. The full text is on the product inserts page.
Limitations
- The test is for whole blood specimens only.
- It indicates only the presence of P.f. antigen. The insert makes no claim for other Plasmodium species.
- It is qualitative: neither the quantitative value nor the rate of increase in P.f. antigen concentration can be determined.
- It should not be used as the sole criterion for the diagnosis of malaria infection.
- A negative result does not at any time preclude the possibility of malaria infection. If the result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended.
Downloads
The package insert contains the full instructions for use, specimen handling and performance characteristics.
Frequently asked questions
Is this a tri-line test?
No. Earlier catalog listings called this product “Tri-line”, but the product insert describes a two-line cassette: one control line (C) and one P.f. test line (T).
Which specimens can be used?
Whole blood only, collected by fingerstick or venipuncture. The insert states: do not use other specimens.
How are kits stored, and are controls included?
Store at room temperature or refrigerated (2–30 °C) in the sealed pouch; do not freeze. Each cassette 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
- Malaria and dengue rapid tests — The ATFirst™ tropical fever range.
- ATFirst™ Dengue IgG/IgM rapid test — IgG and IgM antibodies to dengue virus in whole blood, serum or plasma.
- ATFirst™ HBsAg rapid test — Hepatitis B surface antigen in whole blood, serum or plasma.
- Country station — Rapid test supply by region.
- Lateral flow tests explained — How lateral flow cassettes work.
Request a quote for the ATFirst™ Malaria P.f. 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.