Description

The Ebola Rapid Antigen Test is a lateral flow chromatographic immunoassayintended for the qualitative detection of antigens from Ebola viruses (EBOV,including Zaire Ebola virus, Sudan Ebola virus, and Bundibugyo Ebola virus) in Whole Blood/Serum/Plasma. It provides an aid in the diagnosis of infection with
Ebola viruses.

Principle:Mouse monoclonal Antibodies (mAbs) recognizing the Ebola VP40 matrix protein have been developed to detect the presence of Ebola virus in the whole blood or plasma of suspected Ebola Virus Disease (EVD) patients. The Ebola Rapid Antigen Test is an immunoassay based on the principle of the double antibody-sandwich technique. During testing, anti-EBOV/VP40 mAb is immobilized in the test line region of the device. After a Whole Blood /Serum / Plasma specimen is placed in the Sample Pad, it reacts with anti-EBOV/VP40 mAb coated particles that have been applied to the specimen pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized anti-EBOV/VP40 mAb. If the specimen contains Ebola virus antigen, a colored line will appear in the test line region indicating a positive result. If the specimen does not contain Ebola virus antigen, a colored line will not appear in this region indicating 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. Visual interpretation is made after 25 minutes signal development time.

specification：20T

Storage conditions：Store as packaged in the sealed pouch at room temperature (2-30℃ or 36-86℉).If
stored refrigerated, ensure that the Divided Pouch is brought to operating temperature (15-40℃ or 59-104℉) before opening. The kit is stable within the expiration date printed on the labeling. Once open the pouch, the test should be used within one hour. Prolonged exposure to hot and humid environment will cause product deterioration.

Sensitivity: A Limit of Detection (LOD) range finding study identified 4.60E+04 Copies/mL (1.60E+02 TCID50) as the tentative LOD for Zaire Ebola virus spiked into pooled venous whole blood. This dilution level was confirmed as the LOD by all 20 replicates testing positive.

Cross Reactivity and Interference:

1. Other common causative agents of infectious diseases were evaluated for cross reactivity with the test. Some positive specimens of other common infectious diseaseswere spiked into the Ebola positive and negative specimens and tested separately. No cross reactivity was observed with specimens from patients infected with HIV, LASV, MARV, CCHF, YFV, DENV, CHIKV, RVFV, HAV, HBV, HCV, HTLV, CMV and
2. Potentially cross-reactive endogenous substances including common serum components, such as lipids, hemoglobin, bilirubin, were spiked at high concentrations into the Ebola positive and negative specimens and tested, separately. No cross reactivity or interference was observed to the

3. Some other common biological analytes were spiked into the Ebola positive and negative specimens and tested separately. No significant interference was observed at the levels listed in the table