In a controversial directive, Nepal’s the Ministry of Health and Population has told private and public medical facilities to use RDT (Rapid Diagnostic Test) kits for COVID-19 despite evidence that the method gives inaccurate results.
The directive instructs health facilities to use the RDT method, with kits supplied by nine international firms even though multiple investigations have shown that some of these firms have produced equipment that provide false negatives and positives. Seven of these companies are Chinese, one American and one Canadian.
Of the suppliers approved by the NPHL (National Public Health Laboratories), the testing kits of two Chinese suppliers, Nanjing Vazyme Biotech Co Limited and Zhuhai Livzon Diagnostics Inc, are strictly ‘not recommended for use’ by the World Health Organization (WHO), according to investigations by theInternational Consortium of Investigative Journalists (ICIJ).
ICIJ also identified three other suppliers on the government’s list as producers of defective equipment. Two of these, Beijing Wantai Biological Pharmacy Co. Ltd. and Panbio Abbott, are based in China. The other, Cellex Inc, is based in the United States.
Public health experts say RDT gives inaccurate reports on virus tests, and advocate the use of the more reliable PCR (Polymerase Chain Reaction) on a large scale. However, the Nepal government initially followed the Indian decision to use RDT because results are available almost instantaneously. However, last month India discontinued using RDT because of its unreliability.
Despite this, the ministry is contracting private suppliers to import 100,000 RDT kits within a week. A ministry sources said the decision to allow private institutions to also conduct COVID-19 tests was taken at the behest of some of these firms.
In April, the Ministry of Health and Population instructed that Chinese RDT imported by a private contractor not be used after doubts emerged about their reliability. The ministry has also stopped the use of other kits brought by individuals and private organisations from other sources, until their quality can be assured.
The ministry had hurriedly signed an agreement with Nepal’s Omni Buisness Corporate International (OBCI) on 25 March to purchase 75,000 Rapid Diagnostic Kits from China worth $600,000. The government then also got the Nepal Army to bring in test kits under a government-to-government deal with China.
Prakash Ghimire, director at the Tribhuvan University Microbiology Department, says, “It is not feasible to rely on the methods and results of RDT kits and testing only. Emphasis must be placed on real-time PCR testing.”
This becomes even more important as clusters of community transmission have been detected, and hundreds of thousands of Nepalis from India and overseas start arriving. Experts have recommended keeping returnees in temporary quarantine for two days while their PCR swab sample results come in, and only then send them to self-isolation in home districts if negative.
The government’s puzzling insistence on continuing with RDT comes even as its real-time PCR testing machines and RNA extractors are not being fully used. The new directive recommends that all RDT results returning positive should be immediately verified with PCR tests to confirm them.
The NPHL’s well-equipped PCR testing lab at Teku, complete with BSL-III (Biosafety Level 3), has remained out of operation since 2018. Now, four months after the pandemic broke, the government is finally moving to repair the machine at a cost of Rs 8 million.
The NPHL also has four real-time PCR testing machines that can handle 96 swab samples at once, and one machine that handles 36 samples simultaneously. Of these, only two machines capable of testing 96 samples are working.
A source close to the government’s dealings believes officials are deliberately trying to bypass PCRs for RDTs because of underhand deals. The source said: “The government’s refusal to activate the available lab equipment and waste precious resources is worrying, it means corruption will end up helping the virus spread.”