All Test
Combating Covid-19 Through Antigen And Antibody Tests

Innovative products and services are often backed by profound experience and expertise because, unlike other technological advantages, experience carries with itself a tried and tested foundation to approach any problem that may arise. Such experience has played a vital role in combating COVID-19, where thought leaders from varied industries rose to the occasion to offer innovative products and services to withstand, combat, and fend off the pandemic. The In-Vitro Diagnostics arena, in particular, has brought forth numerous such leaders to the limelight who has contributed immensely to the war against COVID-19 through Point of Care Testing (POCT) products containment measures such as masks and PPE, and vaccines.

One among the forerunners leading this charge is HANGZHOU ALLTest Biotech – an integrated researcher, manufacturer, sales and marketing enterprise for POCT products. ALLTest Biotech provides a comprehensive portfolio of COVID-19 diagnostics/tests solutions, including both Antigen and antibody tests.

A Sturdy Foundation

Within months of the COVID-19 onset, the mortality and morbidity associated with the pandemic forced healthcare infrastructures across the world to create a better measure for isolation and, more importantly, to deduce tests that could detect infection faster and more efficiently. Invariably, vaccines, effective therapeutics, and reliable serological testing methodologies emerged as lethal ammunition in the fight against the pandemic, playing a crucial role in containing the spread of the virus and consequently devising effective countermeasures to gradually eliminate quarantine measures that brought the socio-economic world to a standstill. Studies showed that serological diagnostic tests broaden the understanding of COVID-19 incidence and serve as key indicators to assess immunity among individuals or population groups. However, scientists soon learnt about the discrepancies between claimed and actual performance characteristics among these serological tests, prompting them to conduct a more comprehensive assessment.

At the same time, an independent assessment of more than 1100 point-of-care COVID-19 tests, five direct (antigen/RNA based) tests for the detection of acute infection and six indirect (antibody) tests for detection of prior infection were identified by the renowned group of researchers at NSF international and Novateur Ventures. In accordance with the World Health Organization (WHO) ’s desirable Target Product Profile (TPP) criteria, these 11 tests were identified to empower communities and healthcare systems in making informed decisions. Among the meritorious 11, ALLTest Biotech’s solution emerges as a credible candidate in the indirect POC tests category. According to the study, these 11 candidates “met the World Health Organization’s (WHO) TPP ‘desirable’ criteria for clinical sensitivity/specificity, the limit of detection, and time to results.”

ALLTest Biotech’s rapid tests showed exemplary performance characteristics, offering results within 5-15 minutes, all the while allowing for simplistic ease of operation without equipment training. It encourages easy specimen collection with oral fluid, nasal swab and nasopharyngeal swab (for COVID-19 antigen test) & Fingerstick whole blood specimen (for COVID-19 antibody test). The tests can be further analyzed with LF Reader, Fluorescence Immunoassay Analyzer or PCR for the objective test. Collectively, these benefits validate ALLTest’s competencies in the POCT landscape, bolstered by its research, manufacturing, sales and marketing efforts. Despite the shortcomings of the pandemic, these skills enabled the company to increase publicity and awareness, enhance product quality, and help business partners expand the impact of product and sales performance.

Mastery Over POCT

As veterans in the field of IVD, ALLTest boasts a vast portfolio of products that feature Women’s Health Rapid Test, Infectious Disease Rapid Test, Drug of Abuse Rapid Test, Oncology Rapid Test, Cardiac Marker Rapid Test, Veterinary Rapid Tests. The company also offers Fluorescence Immunoassay System, Biochemistry, and PCR, among others. Having served the industry for over a decade, ALLTest has also nurtured a resilient and innovative R&D team that possesses the capability to launch two to three tests every month.

As veterans in the field of IVD, ALLTest boasts a vast portfolio of products that feature, Women’s Health Rapid Test, Infections Disease Rapid Test, Drug of Abuse Rapid Test, Oncology Rapid Test, Cardiac Marker Rapid Test, Veterinary Rapid Tests

By implementing a strict and sturdy quality management system, the company ensures uncompromised quality across its product line. Effectively, such a team and well-structured manufacturing competence enable ALLTest to provide competitively priced solutions, additions to OEM/ ODM services. Capable of delivering 500 million tests in a year, the company solidified its technological strengths with faster diagnostic testing systems.

Furthermore, ALLTest also has its raw material development team (for antigen and antibody), reagent research and development team, analyzer software systems and electronics research divisions, the combination of which represents 100+ scientists and technicians who possess 10+ years of experience in polyclone antibody (Rabbit and Goat) and mouse monoclonal antibody development and production farms.

The leadership team at ALLTest has played a catalyzing role in various POC transformations that are critical to the current Rapid Tests and the POCT business. Some of these notable engagements include designing industry-leading control systems that were crucial to validation protocols that form the core of stringent quality assessment systems. Through these efforts, the company strives to provide immense value to its stakeholders in the healthcare industry with majority stakes in POCT businesses. Committed to developing innovative solutions through the prowess of modern-day technologies, ALLTest continuously seeds newer innovations that amalgamate modern solutions with techno-commercial sectors of the POCT industry. Recently, ALLTEST received the world first CE OTC certificate for its COVID-19 Antigen Rapid Test (Oral Fluid and Nasal Swab) for self-testing.

Addressing the Need of the Hour

The aforementioned innovative strides, especially in the COVID-19 era, proved invaluable to the healthcare industry, especially for the frontline workforce that was required to contain the spread of the virus and test and vaccinate people around the world. More importantly, ALLTest was able to address a highly critical, unexpected need in the socio-economic spectrum. With economic development coming to a halt across the globe, international business was restricted, requiring enterprises to carry out extensive COVID-19 testing drives within their companies periodically for uninterrupted business operations. As a result, the demand for rapid tests grew exponentially. ALLTest successfully provided a large number of COVID-19 rapid tests to its clientele for the resumption of work and production activities, increasing their sales margins and reducing economic losses caused by the pandemic.

Building on these prosperous collaborations, ALLTest will focus on developing new products and staying true to its competitive spirit; it aims to continue releasing products every month to satisfy both market and end-consumer requirements. With a customer base spanning the entire globe, ALLTest aims to strengthen its product portfolio and emerge as the most reliable provider of IVD products at highly affordable prices without compromising on quality or ease of use.

In the post-pandemic age, ALLTest aims to actualize the healthcare industry’s ability to offer faster POCT to the masses while the socio-economic world strives to regain its long-lost normalcy. The international certifications earned by the company are testament to achieving this objective. ALLTest has procured ISO13485, ISO9001, USFDA, ANVISA, Korean GMP, CFDA, MDSAP, and CE certifications, having registered its products in more than 100 countries around the world. And despite the difficulties in entering global marketplaces such as Germany, Japan, Switzerland, Brazil and more, ALLTest’s products have been whitelisted in more than 40 countries worldwide.