Leishmania Ac Rapid Test

This test is an immunoassay for the qualitative detection of antibodies including IgG, IgM and IgA against the species that make up the Leishmania donovani complex (including Leishmania infantum, the causative agent of canine Leishmaniasis), in serum or plasma. This test is intended to be used as a screening test and as an aid in the diagnosis of canine Leishmaniasis. Any positive sample with this test should be confirmed with an alternative test (available free of charge in our laboratory).
Leishmaniasis is an infection spread by the Phlebotomus mosquito, which acquires the infection by feeding on infected animals. It is also a zoonosis that affects immunocompromised people.
There are numerous laboratory tests for the diagnosis of Leishmaniasis, such as identification of the microorganism in bone marrow, lymph node or spleen, PCR techniques or detection of antibodies by ELISA or IFA. However, all of them require specialized instruments and personnel. The Leishmania Ac rapid test is a serological test based on recombinant proteins, which detects antibodies including IgG, IgM and IgA against the L. donovani complex (including L. infantum). This provides a reliable result in just 10 minutes without any instrumentation requirements.
PRINCIPLE
The Leishmania Ab Rapid Test Device is a lateral flow chromatographic immunoassay. The test device consists of:
1) A burgundy-colored conjugate pad containing the recombinant L. donovani antigen conjugated with colloidal gold and a rabbit IgG-gold conjugate.
2) A nitrocellulose membrane strip containing a band for the positive result (T band) and a control band (C band). The T band is coated with an L. donovani antigen conjugate, and the C band is coated with goat anti-rabbit IgG antibody.
When an adequate volume of serum to be tested is dispensed into the sample well of the test cassette, the sample migrates by capillary action through the cassette. If antibodies against L. donovani are present in the sample, they will bind to the Leishmania conjugates. The immunological complex is captured on the membrane by the coating antigen, forming a burgundy T band, which indicates a positive result and therefore a level of antibodies against L. donovani above the level considered positive.
The absence of the T band indicates a negative result. The test contains an internal control (C band) that must exhibit a burgundy colored band regardless of the color development on the T band. Otherwise, the test result is invalid and the sample must be tested again with another device.
CONTENTS
Individual test devices.
Disposable pipettes for adding the sample.
Buffer.
Package insert.
PRECAUTIONS
-For professional use only.
-Do not use after the expiration date indicated on the package. Do not use the test if its aluminum pouch is damaged.
-This kit contains products of animal origin. Although the origin of the products is known and certified, this does not fully guarantee the absence of transmissible pathogens. Therefore, it is recommended that these products be treated as potentially infectious and handled following usual safety precautions (do not ingest or inhale).
– Avoid cross-contamination of samples by using a new container for sample collection for each new animal.
– Read the entire procedure carefully before performing any test.
– Do not eat, drink or smoke in the area where samples and kits are handled. Handle all samples as if they contained infectious agents. Observe established precautions against microbiological hazards during procedures and follow standard procedures for disposing of waste.
– Use protective clothing, such as disposable laboratory coats, gloves and eye protection when samples are tested.
– The buffered saline solution contains sodium azide which may react with lead or copper and potentially form explosive metal azides. When disposing of the buffered saline solution or extracted samples, always flush with copious amounts of water to prevent acid formation.
– Do not interchange or mix reagents from different lots.
– Humidity and temperature may affect results.
– Used test materials should be disposed of according to current regulations.
STORAGE INSTRUCTIONS
All reagents are ready to use. Store unopened unused devices between 2 °C and 30 °C. Sera or bloods should be brought to room temperature for 10 minutes before use, as well as devices and buffer if stored in the refrigerator. The test device is stable until the expiration date printed on the sealed pouch. Do not freeze the kit or expose the kit to more than 30 °C.
SAMPLE COLLECTION AND HANDLING
-The Leishmania Ab Rapid Test Device can be performed using whole blood, serum or plasma.
– Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only non-hemolyzed samples.
– The test should be performed immediately after sample collection. Do not leave samples at room temperature for prolonged periods. Serum and plasma samples can be stored at 2-8 °C for up to 3 days. For long-term storage, samples should be kept below -20 °C (serum or plasma only).
-Whole blood collected by venipuncture should be stored at 2-8 °C if the test is to be run within two days of collection. Do not freeze whole blood samples.
-Bring samples to room temperature before testing. Frozen samples must be completely thawed and homogenized before testing. Samples should not be frozen and thawed repeatedly.
– If samples must be transported, they should be packaged in compliance with local regulations regarding the transport of biological agents.
ASSAY PROCEDURE
1) Bring samples, buffer and devices to room temperature if refrigerated or frozen. Place the device on a clean, flat surface.
2)
For whole blood
Dispense 1 drop of whole blood (about 40-50 uL) into the sample well. Then, add 2 drops (approximately 80 uL) of the buffer immediately.
For serum or plasma
Dispense 1 drop (about 40 uL) of the sample into the sample well, ensuring there are no air bubbles. Then add 1 drop (approximately 40 uL) of the sample diluent immediately.
3) Results can be read in 15 minutes. Positive results may be visible from 1 minute. Do not read the result after 30 minutes.



INTERPRETATION OF RESULTS
POSITIVE RESULT:
A red band appears in the control region (C) and another colored band appears in the T band region.

NEGATIVE RESULT: A colored band appears in the control region (C). No band is observed in the test band region (T).

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QUALITY CONTROL
Quality controls are available upon request.
TEST PERFORMANCE
Sensitivity relative to the ELISA test is 91.2% and specificity is 99.5%, with an agreement of 98.3%.
TEST LIMITATIONS
1) The assay procedure and interpretation of test results must be strictly followed. Failure to follow the procedure may produce inaccurate results.
2) The Leishmania Ab Rapid Test is limited to the qualitative detection of antibodies for
L. donovani in blood, serum, or plasma. The intensity of the test band does not have a linear correlation with the antibody titer in the sample.
3) A negative result for an individual subject indicates the absence of anti-L. donovani antibodies
above the cutoff line. However, a negative result does not exclude the possibility of exposure to L. donovani.
4) A negative result may occur if the amount of antibodies present against L. donovani is below the detection limits of the assay, or if the antibodies are not present during the stage of the disease when the sample is collected.
5) Some samples containing high titers of heterophile antibodies or rheumatoid factor may affect the expected results.
6) Results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings.
REFERENCES
1. WHO. Control of the Leishmaniasis. World Health Organization. Technical Report Series 1990. No. 793.
2. Rosenthal E, Marty P. Visceral leishmaniasis. Rev Prat 2004;54(20):2211-6.
3. Molina R, Gradoni L, Alvar J. HIV and the transmission of Leishmania. Ann Trop Med Parasitol. 2003;97 Suppl 1:29-45.
4. Allain DS, Kagan IG. A direct agglutination test for leishmaniasis. Am J Trop Med Hyg. 1975;24(2):232-6.
5. Badaro R, Reed SG, Carvalho EM. Immunofluorescent antibody test in American visceral leishmaniasis: sensitivity and specificity of different morphological Am J Trop Med Hyg. 1983;32(3):480-4.
6. Maalej IA, Chenik M, Louzir H, Ben Salah A, et al. Comparative evaluation of ELISAs based on ten recombinant or purified Leishmania antigens for the serodiagnosis of Mediterranean visceral leishmaniasis. Am J Trop Med Hyg. 2003;68(3):312-20.
7. Burns JM Jr, Shreffler WG, Benson DR, Ghalib HW, Badaro R, Reed SG. Molecular characterization of a kinesin-related antigen of Leishmania chagasi that detects specific antibody in African and American visceral leishmaniasis. Proc Natl Acad Sci U S A. 1993 Jan 15;90(2):775-9.