AB Side of Wuhan Nucleic Acid Testing: Patients Worried, Hospitals Swamped, Third Party Agencies "Not Enough to Eat"



Author: JIN Zhe, YUE Qi, CHEN Xing, LIU Ling (National Business Daily)

Translator: Maggie Pan (COVID-19 Readings)

Securing the support of various parties, the “Fire Eye Lab”, a testing agency matched with “Huoshenshan Hospital”, was built within a few days. But after the daily testing capacity of BGI Genomics increased to 10,000 cases, the daily samples they received barely reached over 1,000. The team could finish testing the samples sent over the previous night by noon, and the capacity idle rate was as high as 80%.

On Chinese New Year’s Day (January 25), Wang Jian, the founder of BGI Genomics, rushed from Shenzhen, thousands of miles away, to Wuhan, the worst-hit area of the epidemic. He and three colleagues took a photo in front of the high-speed rail with masks on. Wang Shi, co-chairman of BGI Group, sent a long text to cheer on his battle companions.

February 10, when National Business Daily reporters saw Wang Jian at Wuhan BGI Genomics, this public health expert, known as “fight ingenuity buddha” by the outside world, could not help but sighed at the data on the big screen: “Our machines are all idle in the afternoon, hospital laboratories cannot get a break, the public say it’s hard to get a test.”

Securing the support of various parties, the “Fire Eye Lab”, a testing agency matched with “Huoshenshan Hospital”, was built within a few days. But after the daily testing capacity of BGI increased to 10,000 cases, the daily samples they received barely reached over 1,000. The team could finish testing the samples sent over the previous night by noon, and the capacity idle rate was as high as 80%. Wang Jian’s distress was written on his face, as the one with the highest capacity among the 40 designated nucleic acid testing agencies in Wuhan, BGI Genomics was unable to help.

This is not an isolated case. Wuhan Kindstar Medical Laboratory Co., Ltd. (hereinafter referred to as Kindstar) located less than 200 meters away from Wuhan BGI is also “waiting for the rice to put in the pot”. They have performed only a few hundred tests despite having an average daily testing capacity of 5000 tests. The empty laboratory makes Kindstar employees “anxious”.

Professional third-party testing capacities are sitting idle, front-line patients “cannot get a test”, hospital laboratories are swamped. Wuhan nucleic acid testing is trapped into a strange cycle in the face of the epidemic? National Business Daily reporters recently carried out an in-depth investigation.

February 10, Wuhan BGI Group Chairman, WANG Jian. Image by NBD Journalist: ZHANG Jian

A-Side: “Not Enough to Eat” Third-Party Testing Agencies

At the end of January 2020, Yuan Li (pseudonym)’s parents developed a lung infection, two days in a row, around 4 or 5 am, they had to join the hospital queue to see a doctor. He couldn’t help but spit out helplessness in a weibo post.

Because the hospital’s nucleic acid test kits were used up, Yuan Li’s parents could only undergo a CT examination, with results showing bilateral lung infection with ground glass opacity. Even if the symptoms coincide with COVID-19, without confirmation from the “gold standard” nucleic acid test, Yuan Li’s parents could not be confirmed diagnosed, they could only go to the hospital every day for injection.

Nucleic acid test kits are an important medical resource for the detection of new coronavirus, but they were difficult to find in the early stage. Official data show that before January 16, there were no test kits in Hubei Province, all test samples need to be sent to designated testing agencies in Beijing, the round-trip time for a sample result was 3 to 5 days. Even with the kits later, Hubei provincial CDC’s daily testing capacity was only over 200 per day, and it simply couldn’t match the daily increase in the number of suspected cases.

On January 22, Wuhan Municipal Health and Medical Commission approved 10 aid hospitals and disease control centers to carry out testing of the novel coronavirus. If they were all running, the number of samples that could be processed in one day approached 2000.

Some already sensed that an uphill battle was coming. Wang Jian, a former head of the SARS pathogen group in Beijing, judged that the outbreak of the novel coronavirus pneumonia had many similarities with 17 years ago, and BGI Genomics began developing test kits for the virus. On January 14, a piece of good news broke the silence: BGI Genomics had developed a noval coronavirus nucleic acid test kit. On Chinese New Year’s Day (January 25), Wang and three colleagues left for the hard-hit areas of Wuhan.

On January 26, the State Drug Administration approved the novel coronavirus detection products from four companies, two of which were BGI Genomics and MGI Tech. On the same day, BGI Genomics received 87 samples sent by the CDC, and 188 people to be tested. For the first four operating day the testing capacity were basically saturated. February 1 the number of samples they received broke 2000, and BGI Genomics’ testing capacity then was only 1200, this was the first time Wang Jian felt the heavy overload of the frontline. The following week, BGI Genomics’ research and development team increased the testing capacity to 10,000, but Wang Jian began to worry.

Starting from February 2, the number of samples BGI Genomics received each day has basically never exceeded 2000. February 9 they received 1754 samples, the next day they tested more than 1800 samples, with idle production capacity of more than 8,100 samples.

“You see my numbers here, empty empty empty. On February 1 it was still full, after that there were a lot of emptiness.” Wang Jian pointed to the bar chart on the screen and told reporters that samples collected from the previous day at noon were basically tested by noon. The current testing capacity is at 10,000 cases, the idle rate has reached 80%.

bar chart
Fire Eye Lab PCR Testing Data

In comparison, BGI Genomics is not yet the most frustrated, the neighbor from not faraway Kindstar is even more worried. During the Spring Festival, Kindstar was informed to make preparations for testing for Huoshenshen Hospital, and the logistics department drove back dozens of employees. But until mid-February, in the company’s more than 20,000 square meters of testing area, most of the work stations are still empty.

Kindstar was selected in 2008 as one of China’s “Top Ten Independent Medical Laboratories” in the field of laboratory medicine, with more than 20,000 square meters of testing area mainly used for cancer, high-end genetic testing and other business. For fighting COVID-19, Kindstar directly vacated six floors, a total of 15,000 square meters of testing area, for novel coronavirus testing.

Despite it being the Spring Festival holiday, and most cities in Hubei having been quarantined, Kindstar still managed to restore the testing capacity. Later, management worried that there were not enough reagents, they for one time purchased quite a bit at a high price. Everything was ready, and they expect to be able to test up to 5,000 cases a day.

In the end, Kindstar never received “the rice to go into the pot”. From late January to mid-February, they did only a few hundred tests for the novel coronavirus.

B-side: “Testing Mountain” for Public Hospitals and CDC

According to regulations, suspected cases can only be ruled out after two consecutive respiratory pathogen nucleic acid test negative results, and the standard of lifting isolation and discharge requires in addition to the body temperature returning to normal for more than 3 days and improved respiratory symptoms, two consecutive respiratory pathogen nucleic acid test negative results, so the testing pressure is inevitable.

Duan Chong (pseudonym) from the Daffodil community of Hanyang District of Wuhan did nucleic acid testing on February 9, waited for 6 days to get the test result. Community staff explained that, firstly, the hospital had a large backlog of samples, so it was delayed for a few days; secondly, it took some time for the results to be delivered to the community after hospital testing.

In order to solve the “test hard to get” situation, Hubei provincial level expanded the number of nucleic acid testing agencies, which allowed 13 third-party testing agencies such as BGI Genomics and Kindstar to join the virus testing, meanwhile there are 66 qualified medical institutions and 18 CDC agencies. Up to now, Wuhan has 40 agencies that can carry out nucleic acid testing, with a daily testing capacity of 8000 to 10,000 persons.

According to Hubei provincial announcements, on February 5, the province tested 12,277 samples, Wuhan City 6500 samples, cumulatively tested 89,685 samples in the province, and more than 43,000 samples for Wuhan City. Data obtained by the National Business Daily show that from January 26 to February 5, only 6,000 samples were tested at BGI Genomics. “We are the largest of 35 agencies in Wuhan, but you can’t tell that from the number of samples we get.” Wang Jian was not aware of other agencies’ situations, but he believed that the “Fire Eye Lab”’s testing capacity and efficiency have more room to play.

BGI Genomics has put into operation the “fire-eye laboratory”, which has a single-day testing capacity of 10,000 samples, with the delivery time reduced to six hours. The trial run began on February 5, and as of February 19, BGI Genomics has completed cumulatively more than 34,000 tests in Wuhan, exceeding 3,000 tests in the last three days, but there is still a lot of room given the maximum capacity of 10,000 samples perday, and at least another 7,000 samples can be tested.

Zhu Yanmei, executive director of BGI Group, once went to a hospital and saw that the doctors in the laboratory were mostly manually performing nucleic acid tests, while the Fire Eye lab utilizes the intelligent sample preparation system from MGI Tech, with one-stop nucleic acid extraction, 36 ~ 96 samples can be taken per hour, and one inspector can operate three sets at the same time. “The automated extraction time is 1 hour, and a maximum of 96 samples can be extracted. If it requires protective clothing, it takes about 2 hours to manually extract 1 sample, that is like the hospitals are walking on the winding path in the countryside, while we are driving on the highway.”

“National Business Daily” reporter learned that there is indeed a gap between the testing capacity at some CDC and hospital test centers and third-party testing agencies.

A Tianmen CDC staff member told reporters on February 13 that their laboratory colleagues could test 120 samples a day, the samples collected before were tested by the CDC and Tianmen Central Hospital. In recent days, the number of samples went up, they began to send samples to third-party agencies such as BGI Genomics.

Since the outbreak, the lights on the eighth floor of the Ezhou CDC laboratory had hardly been turned off, all suspected new coronavirus samples from hospitals in the city would be sent to the CDC for final review and confirmation. Working continuously around the clock, day and night, has become routine for the laboratory staff. Yet Ezhou CDC staff told reporters that they collected about 200 samples a day.

After Wang Jian had been in Wuhan for more than 10 days, he took a trip to Xiantao. Wang Jian said at that time he wanted to see what they could help with in laboratory construction and testing, and it turned out to be more testing problems: one was to assist with laboratory equipment, the other was to provide enough test kits. Now, the CDC in the surrounding cities of Wuhan would commission the BGI Genomics for testing, Huanggang and Xiaogan had sent more than 1000 samples.

Some hospital laboratories have long been overwhelmed.

“Discharge and release from isolation need two tests, suspected patient diagnosis also needs two tests, there is a lot of pressure on the labs”. An industry insider familiar with the work of laboratory doctors told reporters that apart from emergency and respiratory departments, the busiest department is the laboratory, plus the hospital also has to run other big and small lab reports, it was common to be understaffed.

National Business Daily reporters noted that Wuhan Jinyintan Hospital laboratory staff are arranging shifts and overtime, often running nucleic acid testing till after 12 o’clock in the middle of the night. Tongji Hospital, affiliated with Huazhong University of Science and Technology, has a daily nucleic acid testing capacity of 1000 samples, running about 180 in batches every 4 hours, testing for 24 hours around the clock without interruption. Wuhan Union Jiangbei Hospital can complete up to 256 samples a day.

A laboratory doctor at Union Hospital affiliated with Huazhong University of Science and Technology once cried in an interview with the media , saying that it was not the test kit at all now, they test 500 samples a day, they were so understaffed, everyone was working around the clock.

Lu Zhongxin, director of the laboratory department of Wuhan Central Hospital, said that since the outbreak the laboratory had been taking on the entire hospital’s testing work load, with the deepening of the understanding of the outbreak, they then added respiratory-related virus nucleic acid tests. The volume was very large from the very beginning of the outbreak. Usually there would be more than 300 samples on a night shift in one hospital area. At that time, because the outbreak was close to the Spring Festival, reagent supply chains were not very smooth, many companies had begun to take holidays.

Lu said, now that I think about it, fortunately there were still a lot of reagents in reserve, plus more than 3000 virus sampling tubes, later, until now, even virus sampling tubes were in short supply and were being rationed. As to testing for the novel coronavirus, there were five or six hundred samples when it was busy, now an average of about two or three hundred samples a day.

lab staff working
February 10, Wuhan BGI Genomics, laboratory staff registering virus samples.

Wuhan CDC Staff: All in Accordance with Policies and Regulations

Virus samples sent to third-party independent testing agencies must be uniformly distributed by the Wuhan CDC or other local city disease control departments. In Wang Jian’s opinion, the government should recognize the professional capabilities and efficiency of third-party testing agencies.

An insider from Kindstar also stressed that the advantages of third-party testing agencies are their experiences and professional training in testing; whereas hospitals are engaged in a large amount of testing work, medical workers can easily be exposed to infection risks without adequate protection, and it also increases the workload of front-line medical workers.

A person in the testing industry also suggested to reporters that nucleic acid testing requires a high degree of specialization from the personnel. After receiving the samples, a specialized personnel is required to perform sample pre-processing. The entire process must finish and results returned to the CDC within two days. There are not as many people in the hospital laboratory that can do nucleic acid testing, and other tests still need to be done, so third-party testing agencies have more advantages in terms of efficiency. The morning after the next day, each hospital and patient can receive the results from the test agency.

In fact, this is not the first time Wang Jian has complained about idle capacity. On January 30, the sixth day since being in Wuhan, he proposed on his public account “Old Wang”, combining his experience from 17 years ago dealing with SARS and his own multiple days’ observation in Wuhan, to breakthrough the epidemic trap, treat accurate testing and diagnosis as important as clinical rescue.

Wang Jian believes that although CT imaging can play a supporting role, viral nucleic acid testing is the “gold standard” for diagnosis, and it is also an important indicator for patients to be discharged from hospital or for close contacts to be released from quarantine. However, there are still significant obstacles to nucleic acid tesing.

In the face of public concern about the accuracy of nucleic acid testing, on February 18, academician Zhong Nanshan pointed out that formal nucleic acid testing should be more accurate, and the method itself has no problems. However, in the sampling process, such as nasopharyngeal sampling, due to the large difference in operation, special attention should be paid to whether the sampling is appropriate. He pointed out that the method of nucleic acid testing should be trusted at present, and more attention should be paid to the standardization of the sampling process.

In Wang Jian’s view, in addition to the sampling process, minimizing manual operation of automated equipment is even more critical. Wuhan and Hubei still have shortcomings in terms of testing specifications, capacity building, quality control, and timely delivery. Hoshenshan, Leishenshan, and the Fangcai Hospitals are the best combination to quickly solving the current problem only when they are equipped with the automated high-throughput “Fire Eye Lab”.

Wearing thick protective clothingin the “Fire Eye Lab”, Wang Jian personally walked through the process, hoping to optimize the testing efficiency again. During the period, academician Zhong Nanshan rang his phone seven times. Because he couldn’t bring a mobile phone, he only saw it when he came out of the laboratory. “He and I discussed some issues, I communicated with him the problems I found in Wuhan from the first day of the New Year to now, and emphasized again that nucleic acid testing based on high-throughput automated equipment is very necessary, not only for suspected case diagnosis and patient rehabilitation, but it is also even more important for Wuhan, a city with tens of millions of people, to revitalize and resume work in an orderly manner.”

Wuhan and Hubei have launched a general offensive. The most critical thing in the next step is to control the outbreak during the resumption of work. Wang Jian suggested that in provinces outside Hubei, it is necessary to carry out universal testing of the workers returning to work as soon as possible to reduce the impact of the epidemic on the economy.

In the afternoon of February 19, the reporters dialed a number of public numbers, including the Infectious Disease Surveillance Office of Wuhan CDC, and the Wuhan Health Hotline. A staff member of the Health Emergency Management Office of the Wuhan CDC provided the duty room’s number to the reporters. The staff member who answered the call told the reporters that according to the current policy, samples will be sent to the CDC and major hospitals for testing. If a hospital reports that the testing volume is overwhelming or that there are too many recent samples, they will be sent to a third-party testing agency for testing. “At present, CDC and hospitals are still the main force.” The staff emphasized that there was no intentional withholding of samples from third-party agencies, and everything was done in accordance with policies and regulations. He also added, “I personally didn’t hear too much about the problem of insufficient volume from third-party agencies, but I know that the hospitals have a large number of tests and tremendous work load.”

National Business Daily reporters also tried to contact a person in charge of the publicity department of the Wuhan Municipal Health and Health Commission, but as of press time, have not received a reply.

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