Infectious Zika IgG/IgM Disease Blood Test, professional screen test use, 4mm cassette, gold colloidal method

Summary:

Zika fever (also known as Zika virus disease) is anillness caused by the Zika virus. Most cases have no symptoms, but when present they are usually mild and can resemble dengue fever.Symptoms may include fever,red eyes,joint pain,headache, and a maculopapular rash. Symptoms generally last less than seven days. It has not caused any reported deaths during the initial infection. Infection during pregnancy causes microcephaly in some babies. Infections in adults has been linked to Guillain–Barré syndrome (GBS). Zika fever is mainly spread via the bite of mosquitoes of the Aedes type. It can also be sexually transmitted from a man to his sex partners and potentially spread by blood transfusions.Infections inpregnant women can be spread to the baby. The test is based on immunochromatography and can give a result within 15 minutes.

TEST PRINCIPLE

The Zika IgG/IgM Rapid Test is a qualitative membrane strip based immunoassay for the detection of Zika virus antibodies (IgG and IgM) in Whole Blood /Serum / Plasma.The test device consists of: 1) a burgundy colored conjugate pad containing Zika recombinant envelope antigens conjugated with Colloid gold (Zika conjugates), 2) a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T1 band is pre-coated with the antibody for the detection of IgM anti-Zika, T2 band is coated with antibody for the detection of IgG anti- Zika. When an adequate volume of test specimen is dispensed into the sample well of the test cassette,the specimen migrates by capillary action across the cassette. IgG anti- Zika, if present in the specimen, will bind to the Zika conjugates. The immunocomplex is then captured by the reagent pre-coated on the T2 band,forming a burgundy colored T2 band, indicating a Zika IgG positive test result and suggesting a recent or repeat infection.IgM anti- Zika if present in the specimen will bind to the Zika conjugates. The immunocomplex is then captured by the reagent coated on the T1 band, forming a burgundy colored T1 band, indicating a Zika IgM positive test result and suggesting a fresh infection.Absence of any T bands(T1 and T2) suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.

4. Hold the buffer vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2 drops of buffer to the sample well.

5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS

Positive:

Two red lines are visible in the result window. The intensity of the test line may be

weaker or darker than that of the control line. This still means a positive result.

Negative:

The control line appears in the result window, but the test line is not visible.

Invalid:

If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

Performance:

The Zika IgG/IgM Rapid Test cassette (Whole Blood/Serum/Plasma) has correctly identified specimens of seroconversion panel and has been compared to a leading commercial ELISA Zika IgG test and Eliza Zika IgM test using clinical specimens.

The results show that the relative sensitivity of the Zika IgG Rapid Test cassette (Whole Blood/Serum/Plasma) is >97.14% , the relative specificity is 98.64% and an accuracy of 98.34%.

The results show that the relative sensitivity of the Zika IgM Rapid Test cassette (Whole Blood/Serum/Plasma) is >92.60% ,the relative specificity is 98.68% and an accuracy of 98.04%.

Conclusion:

The sample correlation results show that the relative sensitivity of the Zika IgG Rapid Test cassette is 97.14%, and the relative specificity is 98.64% and the overall accuracy is 98.43% to be compared with a commercial available Zika IgG ELISA test.

The sample correlation results show that the relative sensitivity of the Zika IgM Rapid Test cassette is 92.60%, and the relative specificity is 98.68% and the overall accuracy is 98.04% to be compared with a commercial available Zika IgM ELISA SET.

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical  Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

Company's core technical team with more than 35 employees，3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.