Toxoplasma Gondii IgG IgM Rapid Test Device

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The TOXO Toxoplasma gondii IgG IgM Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Toxoplasma gondii(Virus) in whole blood, serum or plasma to aid in the diagnosis of TOXO infection.

The Toxoplasma Gondii IgG IgM Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma. FaStep is authorized for use with fingerstick whole blood specimens at the point of care. FaStep has been validated by the FDA and found to be 100% sensitive (30/30) for IgM and 98.8% specific (79/80) for IgM. Sensitivity was 90% (27/30) and specificity was 100% (80/80) for IgG.

The Toxoplasma gondii IgG IgM Rapid Test Device consists of a burgundy colored conjugate pad containing TOXO recombinant envelope antigens conjugated with Colloid gold (TOXO conjugates) and rabbit IgG-gold conjugates, a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). 

Bring Toxoplasma gondii IgG IgM Rapid Test Device, specimens and buffer to room temperature (15-30°C) before use. 

1.  Allow the pouch to come to room temperature before opening it. Remove the test device from the sealed pouch as soon as possible and use it;

2.  Position the test device on a clean, level surface.

3. Holding the dropper vertically, add 1 drop of the specimen up to the Fill Line (approximately 10l), then 2 drops of buffer (approximately 80l), and start the timer.

     4. Allow for the appearance of the colored line(s). After 15 minutes, read the results. After 20 minutes, do not interpret the results.

The Toxoplasma gondii IgG IgM Rapid Test Device is only intended for in vitro diagnostic use. TOXO antibodies should be detected in whole blood, serum, or plasma samples using this test. This qualitative test cannot determine either the quantitative value or the rate of increase in TOXO antibodies. The TOXO IgG/IgM Rapid Test Device will only detect the presence of TOXO antibodies in the specimen and should not be used to diagnose TOXO infection. All results, like all diagnostic tests, must be interpreted in conjunction with other clinical information available to the physician. If the test result is negative and clinical symptoms persist, further testing using other clinical methods is advised.

The TOXO Toxoplasma gondii IgG IgM Rapid Test Device can test whole blood, serum, or plasma. Only clear, non-hemolyzed specimens should be used for this test. To avoid hemolysis, serum or plasma should be separated as soon as possible. Testing should be carried out as soon as the specimens are collected. Do not leave the specimens at room temperature for an extended period of time. Serum or plasma samples can be kept at 2-8°C for up to 7 days. Serum or plasma specimens should be stored at temperatures below -20° C for long periods of time. Whole blood specimens should not be frozen. Whole blood should be tested right away. Bring the specimens to room temperature before testing. Prior to testing, frozen specimens must be completely thawed and thoroughly mixed. Freezing specimens is not recommended.

Before testing, bring the specimen and test kits to room temperature. Make sure the specimen is thoroughly mixed.

Remove the cassette from the foil-wrapped pouch. Use the test as soon as possible, or within one hour of it being available.

Transfer the sample to the cassette's specimen well, then add the buffer and start the timer.

After 15 minutes, once the colored line(s) appear, read the results. Results obtained after 20 minutes are deemed invalid.

1.What does a Toxoplasma IgG test result mean?

Toxoplasma IgG positivity indicates current or previous infection with Toxoplasma gondii. A single Toxoplasma IgG positive result should not be used to diagnose a recent infection. Toxoplasma IgG results that are ambiguous may be due to very low levels of circulating IgG during the acute stage of infection.

2.What are the symptoms of human toxoplasmosis?

Toxoplasmosis symptoms include fever, swollen glands, and muscle aches. Most people who contract Toxoplasma have no symptoms. Symptoms usually appear one to three weeks after being exposed to the parasite. Symptoms typically last 2 to 4 weeks.

3.Is it possible to fully recover from toxoplasmosis?

Toxoplasmosis is usually reversible in healthy people. Ill people can be treated with a combination of drugs such as pyrimethamine and sulfadiazine, as well as folinic acid.

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