THE Food and Drug Administration-approved Boson rapid test can detect if patients are infected with SARS-CoV-2, the virus that causes the coronavirus disease 2019 (COVID-19).
Jenka Global, the distributor of the test kits in the Philippines, said this qualitative lateral-flow immunochromatographic assay may be considered by those who experience any COVID-19 symptoms, have come in contact with infected people or returned from countries with reported COVID-19 cases.
It can also help health care facilities make fast diagnoses as well as contain the coronavirus as quickly as possible.
Testing more people not only identifies and isolates patients with possible COVID-19 but also helps prevent infecting others, said Koko Tamura, marketing manager of Jenka.
The rapid test is developed and manufactured by Xiamen Boson Biotech Co. Ltd. and is exported to more than 70 countries worldwide.
Liu Bin, Boson quality manager, said the coronavirus rapid test, which is for health care professional use only, offers fast detection, high accuracy and long shelf-life. It can be stored easily and used for different types of samples.
According to Bin, the rapid test can help with early identification and diagnosis of suspected cases, as well as timely quarantine of confirmed patients to effectively reduce the sources of infection and prevent disease spread.
Bin mentioned that a definitive clinical diagnosis should not be based on the result of nucleic acid or antibody tests alone.
“It should be made after all clinical and laboratory findings have been evaluated, including nucleic acid tests, antibody tests, and clinical symptoms,” Bin said.
By using nucleocapsid and spike-receptor-binding domain proteins, “our test cards are highly sensitive to COVID-19 infections and are less likely to be affected by virus mutation,” Bin added.
Health care professionals can refer to the instructions for use of the product, and should follow good laboratory practice and biosafety guidelines.
The company said the CE-marked Boson rapid test has 87.8 percent sensitivity and 99 percent specificity, and delivers the result with an accuracy of 96.8. Patients get the results within a very short time frame – 15 minutes.
While all manufacturers inevitably encounter incidences of false positives and negatives, Bin said they can only ensure that each batch of products “achieve the optimal quality” – strict control of raw materials, optimization of technical details, and strict quality control throughout research and development (R&D) and production processes.
Boson has around two decades of R&D experience, quality management system, comprehensive production, and well-established good customer service addressing problems during the product use.
In case of quality issues, Bin said the company implements measures to ensure that every batch of products can meet the standard requirements.
Jenka eyes to distribute more of this rapid test kit to the local market in the third quarter of this year, Tamura said, to help get more people tested and detect COVID-19 cases.
Tamura likewise emphasized that the coronavirus test kits are only sold following a strict guideline such as a required physician’s request certifying that a physician shall facilitate the testing.
Jenka has partnered with several local clinics and laboratories to help businesses gain access to rapid testing if these do not have in-house or office physicians. “We ensure that only medical professionals conduct and facilitate the testing to ensure that it is done safely and correctly,” Tamura pointed out.
After the COVID-19 outbreak, Bin said members of Boson’s R&D team have sacrificed their holidays with family and took initiative to conduct frontline research on the 2019-nCoV test reagents.
All other production, quality and sales personnel have also returned to work even under high-risk environments, Bin added, “with the aim to produce high-quality products in the shortest period of time, and contribute to the combat against the ongoing pandemic.”
After customers make an order, “we will follow up with the whole process and provide timely updates on the production and shipping information,” Bin said, noting they answer all questions in a timely manner through emails, phone calls or other messaging apps.
“We are devoted to providing first-class after-sales service to our customers,” Bin said of Boson whose facility is operated strictly under ISO 13485:2016 and GMP guidelines.