TERMS & CONDITIONS
For Healthcare Professional Use Only.
AngelWorld Biotech Manufacturing FZ LLC manufacture Rapid Diagnostic Tests (RDTs) these RDTs are sold, marketed, and distributed under the brand EVO Rapid Diagnostic Test Kits by EVO Healthcare Limited. The EVO Rapid diagnostic test kits give a preliminary diagnosis of an infection however they cannot replace laboratory and clinic-based tests. Neither should these RDTs be used in isolation to diagnose a condition. RDTs should be conducted by a trained healthcare professional who should be responsible to administer or supervise an RDT.
EVO Antigen RDT
The EVO Antigen RDTs can be used for point of care testing, however, should be conducted by a trained healthcare professional in line with local, national, and international guidelines and protocols of RDT usage. For best results, this test should be used in conjunction with a PCR test and within a full testing and diagnosis protocol. The use of EVO RDTs for self-testing is dependent upon rules and regulation of individual countries, if you are buying this product for self-testing it is highly recommended that you consult with a healthcare professional along with local healthcare authorities to understand the rules and regulations for using RDTs for self-testing. We recommend that you follow whatever guidance is given and we cannot be liable for any problems from not following this guidance. EVO COVID 19 Antigen RDT can only be administered and supervised by a health care professional as per the W.H.O and Directive (93/42/EEC) Related to Medical Device Directive (MDD) by regulation (EU) 2007/47/EU.
EVO Antibody RDT
AngelWorld V2.0 COVID-19 IgG and IgM Antibody Rapid Test is manufactured by AngelWorld Biotech Manufacturing FZ LLC.
Sold, Marketed and Distributed by EVO Healthcare Limited as the EVO IgG and IgM COVID-19 Antibody Rapid Test. Registered with the US Food and Drug Administration (US FDA), Emergency Use Authorization Submission Number: EUA202263.Applicant: AngelWorld Biotech Manufacturing FZ LLC Device: AngelWorld V2.0 COVID-19 IgG/IgM Antibody Rapid Test. ISO 13485:2016, AngelWorld Biotech Manufacturing FZ LLC, Certificate MD-97128072324
CE Marketing -Directive (93/42/EEC) Related to Medical Device Directive (MDD) by regulation (EU) 2007/47/EU AngelWorld Biotech Manufacturing FZ LLC, Certification Number SCS 180011024.
A negative result on the Evo IgG/IgM Rapid Antibody Test does not necessarily mean that there is not an active COVID-19 infection. For best results follow the recommendations of a healthcare professional and government guidelines. Please contact a healthcare professional for any further information and questions on COVID-19 testing or refer to the World Health Organization COVID-19 testing guidelines.
Immunity to COVID-19 is based on detecting the IgG Antibody. Currently there is limited research & data on how long immunity lasts after infection. The EVO Smart Immunity IgG Rapid Antibody Test will only detect whether there is an active IgG Antibody at the time at the time the test is conducted. However there is no guarantee on how long immunity to COVID-19 can last. Regular Testing is required to ensure immunity is actively present on an ongoing basis. In independent clinical trials undertaken at 3 major prestigious university medical hospitals in China on sample size of 450,
The Covid19 IgG & IgM Smart Test Kit Cassette displayed a combined sensitivity of 95.1% and a combined specificity of 100% and PPA of 98.18% (8-14 Days). The Covid19 IgG & IgM Smart Test Kit Cassette has been evaluated to a leading commercial RT-PCR testing using clinical specimens on a BGI machine which is approved by US FDA, China NDMA, Japan PMDA, CE and Canada Health Authority. From results of 360 negative and positive samples, it is observed that the IgG rapid test has good clinical performance as compared to RT-PCR.
EVO Mobile App
The EVO Mobile Help (EVO App) is used in combination with the EVO RDT. The EVO app is used as to guide how to conduct the test and how to read the result; however the presence of a healthcare professional is recommended to ensure that the reading is correct. The healthcare professional or institution conducting the test should be the final authority to give any diagnosis and recommended any further treatment. The EVO App will also produce a Digital PDF of the test result which is stored on the user mobile device. The EVO app can be accessed only through a smartphones mobile web browser.