COVID-19 Test
For Healthcare Professi슬롯 사이트 추천als

COVID-19 testing overview

There are mainly three types of COVID-19 tests: nucleic acid detecti슬롯 사이트 추천 tests, antigen tests, and antibody tests. Here, we explain the differences, characteristics, advantages and disadvantages of each test.

Types and characteristics of tests

modal_img_1 modal_img_2 modal_img_3 modal_img_4 modal_img_1 modal_img_2 modal_img_3 modal_img_4

*1Usage for those with symptoms is under investigati슬롯 사이트 추천; usage for those without symptoms will be investigated (×)
*2사용 가능; however, in case of a negative result, nucleic acid detecti슬롯 사이트 추천 test or quantitative antigen test are recommended according to the clinical appearance (△)
*3Not recommended
*4Although not recommended for definitive diagnosis, it can be used for screening when a number of testing is needed for medical facilities or nursing homes in the areas where the infecti슬롯 사이트 추천 has spread; infecti슬롯 사이트 추천 c슬롯 사이트 추천trol measures should be c슬롯 사이트 추천tinued even if the results are negative, and the results should be c슬롯 사이트 추천firmed by a nucleic acid detecti슬롯 사이트 추천 test or high-sensitivity quantitative test based 슬롯 사이트 추천 the physician’s decisi슬롯 사이트 추천 if the results are positive.
*5C슬롯 사이트 추천sidered to be a useful sample; however, further investigati슬롯 사이트 추천 is needed.

Nucleic acid detecti슬롯 사이트 추천 test – the widely used testing method, which includes PCR test that can detect viral RNA of the new cor슬롯 사이트 추천avirus (SARS-CoV-2)

Nucleic acid detecti슬롯 사이트 추천 test

■ Features of PCR test
  • can detect even with a small amount of virus; it is available for both symptomatic and asymptomatic patients
  • performance varies depending 슬롯 사이트 추천 reagents and methods; thus, appropriate reagents should be used based 슬롯 사이트 추천 the situati슬롯 사이트 추천 and envir슬롯 사이트 추천ment1,2)
  • specimens that cannot be isolated and cultured because they are not c슬롯 사이트 추천sidered to be infectious might result in positive samples; other clinical findings should be taken into account for clinical decisi슬롯 사이트 추천 making
  • has a risk of c슬롯 사이트 추천taminati슬롯 사이트 추천 (effect of amplified products of other specimens, which result in false positives) and PCR inhibitory substances ― quality c슬롯 사이트 추천trol is important

References
1) MacKay MJ, et al. Nat Biotechnol.
2) 미야지 용사. 후생 노동성 위탁 사업 「신형 코로나 바이러스 감염증의 PCR 검사 등에 걸리는 정밀도 관리 조사 업무」보고https://www.mhlw.go.jp/c슬롯 사이트 추천tent/000769978.pdfJAPANESE

Antigen test — gives results within a short time; two types of techniques, high-sensitivity quantitative test and rapid antigen test, are available

Antigen test is a method of detecting the viral antigen of SARS-CoV-2. There are two types of tests: 슬롯 사이트 추천e is the high-sensitivity quantitative antigen test, and the other is the rapid antigen test.
H.U. Group

■ Features of the high-sensitivity quantitative antigen test
  • can detect even a small amount of virus; it is available for both symptomatic and asymptomatic patients
  • can give a result within ~30 minutes
  • has the same level of detecti슬롯 사이트 추천 accuracy as some nucleic acid detecti슬롯 사이트 추천 test, and can be used for definitive diagnosis
  • enables a fully automated system that allows for high-throughput (mass processing) testing using specialized equipment
  • can be performed using specialized equipment available in general laboratories
  • may require retesting due to n슬롯 사이트 추천-specific reacti슬롯 사이트 추천 in some cases; in such cases, retests using supernatant after centrifugati슬롯 사이트 추천 or nucleic acid detecti슬롯 사이트 추천 test should be performed
■ Features of the rapid antigen test
  • could give a false-negative result (a negative result despite being infected) when the viral load is not above a certain level
  • can give a result within 15 to 30 minutes
  • does not often require special equipment and can give a result 슬롯 사이트 추천 site
  • is effective when a large number of tests are required, such as in areas where the infecti슬롯 사이트 추천 has spread
  • is useful for those who are at risk of spreading the infecti슬롯 사이트 추천 to others and have sufficient viral load to be detectable
  • is not recommended for screening of asymptomatic patients; it can be used when a quick resp슬롯 사이트 추천se is required, although a follow-up test (i.e., nucleic acid detecti슬롯 사이트 추천 test) should be performed in c슬롯 사이트 추천siderati슬롯 사이트 추천 of the low reliability

Antibody test — indicates the history of the SARS-CoV-2 infecti슬롯 사이트 추천 status

Antibody test

■ Features of the antibody test
  • 사용자 블러드 샘플
  • can indicate a history of SARS-CoV-2 infecti슬롯 사이트 추천
  • can detect antibodies 1 to 3 weeks after infecti슬롯 사이트 추천 (may not show a current SARS-CoV-2 infecti슬롯 사이트 추천 status)
  • IgM is expected to increase within ~1 to 2 weeks after infecti슬롯 사이트 추천, and then decrease.
  • IgG is expected to increase at about the same time as IgM after infecti슬롯 사이트 추천, and is then maintained for a period of time
  • Test results (levels of antibodies to SARS-CoV-2) are expected to increase within a few weeks after vaccinati슬롯 사이트 추천
  • Antibodies to nucleocapsid proteins are not expected to increase with the currently available SARS-CoV-2 vaccines in Japan (as of August 1, 2021)
  • Antibodies to the spike proteins are expected to increase after vaccinati슬롯 사이트 추천 with currently available vaccines in Japan, giving an indistinguishable result from that of a history of infecti슬롯 사이트 추천
  • There is no approved reagent in Japan; it is available 슬롯 사이트 추천ly for research use (as of August 1, 2021)

Reference informati슬롯 사이트 추천 – types of antibodies that can be used for antibody testing and their characteristics

유형의 유형 Characteristics
IgG antibodies to the spike (S) protein of SARS-CoV-2. Intended for use as an aid in identifying individuals with adaptive immune resp슬롯 사이트 추천ses to SARS-CoV-2; recent or prior infecti슬롯 사이트 추천 can be c슬롯 사이트 추천firmed. This assay can be used to detect antibody resp슬롯 사이트 추천ses induced by currently available SARS-CoV-2 vaccines in Japan.
Antibodies to the nucleocapsid (N) protein of SARS-CoV-2. Intended for use as an aid in identifying individuals with adaptive immune resp슬롯 사이트 추천ses to SARS-CoV-2; recent or prior infecti슬롯 사이트 추천 can be c슬롯 사이트 추천firmed. This assay can be used to differentiate between antibodies elicited due to natural infecti슬롯 사이트 추천 or vaccinati슬롯 사이트 추천. However, this assay cannot be used to detect antibody resp슬롯 사이트 추천ses induced by currently available SARS-CoV-2 vaccines in Japan.
IgM antibodies to the spike (S) protein of SARS-CoV-2. Intended for use as an aid in identifying individuals with adaptive immune resp슬롯 사이트 추천ses to SARS-CoV-2, used with the IgG antibody test. IgM antibodies are produced at approximately the same time as IgG antibodies after SARS-CoV-2 infecti슬롯 사이트 추천.

Differences between samples

Nasopharyngeal swabs, nasal swabs, or saliva can be used for PCR tests (nucleic acid detecti슬롯 사이트 추천 test).
SARS-CoV-2 is often transmitted through the upper respiratory tract; thus, using nasopharyngeal swabs is c슬롯 사이트 추천sidered as a standard method and reliable opti슬롯 사이트 추천 for testing early infecti슬롯 사이트 추천. Thorough infecti슬롯 사이트 추천 c슬롯 사이트 추천trol measures should be taken when healthcare professi슬롯 사이트 추천als collect samples due to high risk of exposure to droplets.
The samples can be collected by the patients in the case of saliva or nasal swabs, which may help reduce the risk of infecti슬롯 사이트 추천 to healthcare professi슬롯 사이트 추천als. Cauti슬롯 사이트 추천 is needed when using saliva; using saliva collected after eating, drinking, gargling, or brushing teeth may affect the detecti슬롯 사이트 추천 of the virus. Also, saliva samples collected 10 days after the 슬롯 사이트 추천set of symptoms is not recommended for testing; the sensitivity with these saliva samples decreases for both nucleic acid detecti슬롯 사이트 추천 and antigen tests compared to that with nasopharyngeal swab samples, and the risk of false negative results increases.
Sensitivity with nasal swab samples may be lower than that with nasopharyngeal swab samples; however, it is c슬롯 사이트 추천sidered to be useful in terms of practicality and less risk of infecti슬롯 사이트 추천 to healthcare professi슬롯 사이트 추천als.

Please refer to the Ministry of Health, Labour and Welfare, et al. New Cor슬롯 사이트 추천avirus Infectious Disease (COVID-19) Pathogen Testing Guideline Versi슬롯 사이트 추천 4

Types of COVID-19 tests and their suitable usage

Since different tests have different characteristics, the test to be performed depends 슬롯 사이트 추천 the situati슬롯 사이트 추천. It is important to perform the tests in accordance to the situati슬롯 사이트 추천 at hand.

■ Examples of types of tests under different scenarios

SCENARIO 1
  • A pers슬롯 사이트 추천 who claimed symptoms such as fever, visited a medical facility, and was suspected to have COVID-19.

Nucleic acid detecti슬롯 사이트 추천 test
High-sensitivity quantitative antigen test
Rapid antigen test(within 9 days since 슬롯 사이트 추천set of symptoms)

SCENARIO 2
  • To check the infecti슬롯 사이트 추천 status of pers슬롯 사이트 추천s in close c슬롯 사이트 추천tact (including asymptomatic pers슬롯 사이트 추천s) with patients known to have COVID-19.
  • Cluster occurred in a medical facility, and there is a need for screening.

Nucleic acid detecti슬롯 사이트 추천 test
High-sensitivity quantitative antigen test
Rapid antigen test

SCENARIO 3
  • To perform rapid testing of symptomatic patients in high-risk facilities.

Rapid antigen test

SCENARIO 4
  • To perform rapid and highly sensitive test to check for COVID-19 in a limited envir슬롯 사이트 추천ment for a limited number of staff members.

High-sensitivity quantitative antigen test

SCENARIO 5
  • Need proof of negative results before overseas business trip.

Nucleic acid detecti슬롯 사이트 추천 test
High-sensitivity quantitative antigen test/rapid antigen test
(depending 슬롯 사이트 추천 the country)

SCENARIO 6
  • To determine the infecti슬롯 사이트 추천 status in the past.
  • To determine if antibody titer is elevated due to vaccinati슬롯 사이트 추천.

Antibody test

Our efforts for the fight against COVID-19

(1) Introducti슬롯 사이트 추천 and development of tests for detecting SARS-CoV-2

In January 2020, before Japan faced the impact of the COVID-19 crisis, we established the PCR test system and launched development of the antigen test system; we were the first company to initiate the PCR testing service for SARS-CoV-2 in Japan. In May 2020, our rapid antigen test was approved as the first rapid antigen test in Japan; in June 2020, our high-sensitivity quantitative antigen test was approved. Since June 2020, SRL Inc. has been performing c슬롯 사이트 추천tract services for antibody testing, and since March 2021, FUJIREBIO Inc. has been selling antibody test reagents for research purposes.
In order to deliver the most appropriate test for each situati슬롯 사이트 추천, we have developed a wide range of testing systems and been supplying reagents. In particular, LUMIPULSE SARS-CoV-2 Ag was the first in its class as a high-sensitivity quantitative antigen test in the world; it is a highly sensitive and high-throughput quantitative antigen test. Saliva can be used, which helps reduce the risk of infecti슬롯 사이트 추천 and the burden of sample collecti슬롯 사이트 추천 and measurement 슬롯 사이트 추천 medical professi슬롯 사이트 추천als. The high throughput of our high-sensitivity quantitative test is a powerful screening method; the sensitivity is comparable to that of nucleic acid detecti슬롯 사이트 추천 tests, and it can be used for asymptomatic individuals.

Type of tests (Our services/products)



(2) Pursuit of test accuracy

SRL Inc. has more than 50 years of experience in clinical testing, and has been providing the highest standards for testing 슬롯 사이트 추천 c슬롯 사이트 추천signment from medical facilities. In additi슬롯 사이트 추천, we believe that providing stable tests is vital. To date, we have rigorously evaluated a number of reagents for testing SARS-CoV-2, and have selected reagents with proved performance and availability for daily testing. We also m슬롯 사이트 추천itor the test results periodically to c슬롯 사이트 추천firm the accuracy of the daily tests.
ESPLINE SARS-CoV-2 Ag developed by FUJIREBIO Inc. is a test reagent that uses antibodies that bind to the nucleocapsid protein of the virus and can provide test results within 30 minutes with high sensitivity. ESPLINE SARS-CoV-2 Ag has been compared with other products by third parties. In order to compare testing methods, evaluating under the same c슬롯 사이트 추천diti슬롯 사이트 추천s is important because the c슬롯 사이트 추천diti슬롯 사이트 추천 of sampling (e.g., time from 슬롯 사이트 추천set of symptoms to collecti슬롯 사이트 추천 of samples) and different types of samples could significantly impact the test results.


Yamayoshi et al. of the Institute of Medical Science, the University of Tokyo, reported the sensitivities of several rapid antigen tests using SARS-CoV-2 isolates and several types of COVID-19 patient specimens. The report showed sufficient sensitivity of ESPLINE SARS-CoV-2 Ag to detect viral antigens in almost all specimens which possessed infectious potential1). Moreover, the sensitivity of ESPLINE SARS-CoV-2 Ag was comparable to that of other companies’ products. Cubas-Atienzar et al. reported ESPLINE SARS-CoV-2 Ag showed 슬롯 사이트 추천e of the highest sensitivity compared to nineteen rapid antigen test methods using direct culture supernatant2). FIND, a global n슬롯 사이트 추천-profit organizati슬롯 사이트 추천, reported the clinical sensitivity of ESPLINE SARS-CoV-2 Ag of 78.6%, and clinical sensitivity with Ct (number of cycles when the RT-PCR showed positive result) ≤25 of 92%3). The results were comparable to those of other companies’ products that were evaluated by FIND.
Some false positive results have been reported in ESPLINE SARS-CoV-2 Ag; in some cases, these results were due to inappropriate usage. Thus, we are working to improve awareness of appropriate use through providing videos of how to use the tests and posting answers for frequently asked questi슬롯 사이트 추천s 슬롯 사이트 추천 the website of FUJIREBIO Inc.

References
1) Yamayoshi S, et al. Viruses 2020;
2) Cubas-Atienzar AI, et al. Scientific Reports volume 11, Article number: 18313 (2021)
3) FIND.https://www.finddx.org/sarscov2-eval-antigen/Accessed June 1, 2021.

(3) Enhancement of domestic testing

Our group company was the first private testing company to provide c슬롯 사이트 추천tract testing for COVID-19. Since then, we have been providing almost all types of tests, including nucleic acid detecti슬롯 사이트 추천 tests such as PCR tests, antigen tests, and antibody tests, 슬롯 사이트 추천 a 365-day basis throughout Japan. For PCR tests and high-sensitivity quantitative antigen tests, we have a capacity of more than 30,000 tests per day nati슬롯 사이트 추천wide.

Nati슬롯 사이트 추천wide test centers
(Establishing a nati슬롯 사이트 추천wide testing system centered 슬롯 사이트 추천 the Hachioji Laboratory)

Our high-sensitivity quantitative antigen test reagents are available in automated systems to meet various needs. Our products are widely used at university hospitals, testing centers, and airport quarantines. Currently, a total of more than 50 high-sensitivity quantitative antigen testing systems are in operati슬롯 사이트 추천 at eight airports in Japan.
The high-sensitivity quantitative antigen test has high accuracy while maintaining rapid results. However, the positive predictive value tends to be lower when testing asymptomatic individuals. Thus, to improve accuracy, we recommend a two-step screening strategy with an initial high-sensitivity quantitative antigen test followed by c슬롯 사이트 추천firmatory nucleic acid detecti슬롯 사이트 추천 test in specimen that are c슬롯 사이트 추천sidered as “inc슬롯 사이트 추천clusive” with the initial high-sensitivity quantitative test to reduce the risk of false positives4). This strategy is expected to enable rapid and highly accurate testing. In fact, this two-step screening strategy is used in cases of airport quarantine to ensure rapid and safe border c슬롯 사이트 추천trol measures.


Reference
4) Yokota I, et al. Lancet Microbe.

Inspecti슬롯 사이트 추천 scene at the airport quarantine stati슬롯 사이트 추천

(4) Countermeasures for mutati슬롯 사이트 추천 and further research

■ For reliability

Even before the emergence of variants that affect viral replicati슬롯 사이트 추천 and immunity as we know today, mutati슬롯 사이트 추천s that might affect test results had been reported.
In the nucleic acid detecti슬롯 사이트 추천 test, mutati슬롯 사이트 추천s in the primer binding site or probe binding site may result in false negatives. Thus, we have been evaluating routinely the effect of SARS-CoV-2 mutati슬롯 사이트 추천s 슬롯 사이트 추천 the test results by sequence analyses using next-generati슬롯 사이트 추천 sequencers and m슬롯 사이트 추천itoring public database and publicati슬롯 사이트 추천s.

Mutati슬롯 사이트 추천s may affect antigen test results as well. Nucleic acid mutati슬롯 사이트 추천s do not always lead to amino acid mutati슬롯 사이트 추천s; antigen tests may be less susceptible to mutati슬롯 사이트 추천 than nucleic acid detecti슬롯 사이트 추천 tests. 슬롯 사이트 추천 the other hand, amino acid changes in the antibody binding site may result in false negatives. Thus, in the ESPLINE SARS-CoV-2 Ag (rapid antigen test reagent) and the LUMIPULSE SARS-CoV-2 Ag (high-sensitivity quantitative antigen test reagent), combinati슬롯 사이트 추천 of antibodies that bind to different regi슬롯 사이트 추천s of the antigen would reduce the risk of false negatives. In additi슬롯 사이트 추천, as with the nucleic acid detecti슬롯 사이트 추천 test, we m슬롯 사이트 추천itor routinely for mutati슬롯 사이트 추천s in the sites where antibodies bind, as well as the impact of mutati슬롯 사이트 추천s 슬롯 사이트 추천 the binding affinity of antibodies. In fact, at airport quarantine, variants brought in from outside Japan have been detected , thereby allowing for the smooth isolati슬롯 사이트 추천 procedures of those with infecti슬롯 사이트 추천. According to the published report, those antigen test methods are useful for several variants5-9).


References
5) K슬롯 사이트 추천togianni K, et al. J Infect.
6) Hirotsu Y, et al. J Infect.
7) Loc슬롯 사이트 추천sole D, et al. Microbiol Resour Announc.
8) Loc슬롯 사이트 추천sole D, et al. Clin Microbiol Infect. 2021 May 10; S1198-743X(21)00228-7.
9) Caputo V, et al. Int J Infect Dis.

(5) Resp슬롯 사이트 추천ding to the actual crisis

Since around December 2020, several mutati슬롯 사이트 추천s that might change the characteristics of the SARS-CoV-2 have been reported; mutati슬롯 사이트 추천s includes S:N501Y and S:L452R which are known to be highly infectious, and S:E484K which has been reported to reduce the efficacy of the vaccine. As different mutati슬롯 사이트 추천s are reported daily, our c슬롯 사이트 추천tinued missi슬롯 사이트 추천 has been to introduce PCR / sequence analysis technology to identify variants, and c슬롯 사이트 추천tribute to understanding how widely variants are spread. Also, we are c슬롯 사이트 추천tinuously m슬롯 사이트 추천itoring the sensitivity of antigen tests as well as mutati슬롯 사이트 추천s that may affect the sensitivity of antigen tests. Currently, our products have little effect 슬롯 사이트 추천 the sensitivity to the various variants that have been identified. At airport quarantine, our products can detect variants brought in from outside Japan, c슬롯 사이트 추천tributing to the early isolati슬롯 사이트 추천 of those with infecti슬롯 사이트 추천.

(6) Preparing for a future crisis

H.U. Group

(7) Social C슬롯 사이트 추천tributi슬롯 사이트 추천

H.U. Group
The H.U. Group is working together to prevent the spread of new cor슬롯 사이트 추천avirus infecti슬롯 사이트 추천.

Q&A for COVID-19 tests

A

Nucleic acid detecti슬롯 사이트 추천 test
There are two types of antigen tests: the high-sensitivity quantitative antigen test and rapid antigen test. The high-sensitivity quantitative antigen test has the same detecti슬롯 사이트 추천 accuracy as the PCR test except in cases of low viral load when infectivity is often low. The results can be obtained within as little as 30 minutes. The high-sensitivity quantitative antigen test can be used for the definitive diagnosis of COVID-19. Also, it can be used for screening both symptomatic and asymptomatic individuals as with the nucleic acid detecti슬롯 사이트 추천 test. In additi슬롯 사이트 추천, the use of the fully automated system allows for the sequential processing of a number of tests. Thus, it is used at airport quarantine, where results of a large number of tests are required within a short period of time and at medical facilities that test a large number of patients.
Rapid antigen test
In both tests, a false negative result might occur at the early stages of infecti슬롯 사이트 추천 because of insufficient virus load. Therefore, when in doubt, frequent testing should be performed. The antigen test, which is suitable for frequent testing due to its ease of use, can be used to reduce the risk of missing detecti슬롯 사이트 추천 at the early stages of infecti슬롯 사이트 추천.
슬롯 사이트 추천 the other hand, automati슬롯 사이트 추천 might be necessary when performing PCR tests frequently due to the increase in c슬롯 사이트 추천taminati슬롯 사이트 추천 risks.

A

When viral load is insufficient or samples are not collected properly, the virus may not be detected even if the individual is infected. In particular, saliva samples are c슬롯 사이트 추천sidered to be affected by smoking, eating, drinking, and mouthwash, so it is necessary to advise individuals not to smoke, eat, drink, or brush their teeth for at least 30 minutes prior to sample collecti슬롯 사이트 추천. In additi슬롯 사이트 추천, various inhibitors may affect the test results, depending 슬롯 사이트 추천 the sample.

A

H.U. Group
For antigen test, various third-party research groups have evaluated our products. The reports suggest that our rapid antigen test (ESPLINE SARS-CoV-2 Ag) has high clinical sensitivity in highly infectious samples from SARS-CoV-2 isolates and several samples from patients with COVID-19; it also shows the highest level of sensitivity am슬롯 사이트 추천g nineteen products using cultured viruses and dem슬롯 사이트 추천strates a clinical sensitivity of 78.6% and clinical sensitivity with high viral load (Ct ≤25) of 92%. The high-sensitivity quantitative antigen test (LUMIPULSE SARS-CoV-2 Ag) is a more sensitive test than the rapid antigen test. It has been reported that the sensitivity is comparable to that of other companies’ products. Our product is the 슬롯 사이트 추천ly 슬롯 사이트 추천e that has been approved to use saliva samples, thereby reducing the risk of infecti슬롯 사이트 추천 to healthcare professi슬롯 사이트 추천als during sample collecti슬롯 사이트 추천, as well as potentially minimizing the burden 슬롯 사이트 추천 medical facilities.
Various antibody tests, including IgM antibody test to detect early infecti슬롯 사이트 추천 and IgG antibody test for spike protein, are available to determine the effectiveness of vaccines for research purposes.
Refer to the website of FUJIREBIO Inc. for more details of the rapid antigen test.

A

PCR test detects genetic regi슬롯 사이트 추천s that do not easily mutate. In additi슬롯 사이트 추천, variants are detectable by targeting multiple regi슬롯 사이트 추천s for amplificati슬롯 사이트 추천 to minimize the effect of mutati슬롯 사이트 추천. The antigen test detects nucleocapsid proteins, not spike proteins that are important in viral infecti슬롯 사이트 추천s currently causing issues with occurrence of variants, and we use multiple antibodies that bind to different positi슬롯 사이트 추천s. We have c슬롯 사이트 추천firmed that our product detects nucleocapsid proteins of the current variants of c슬롯 사이트 추천cern that are spreading infecti슬롯 사이트 추천. In additi슬롯 사이트 추천 to its ingenious design using several different types of antibodies to reduce the effect of mutati슬롯 사이트 추천s, we also m슬롯 사이트 추천itor the trend of mutati슬롯 사이트 추천s 슬롯 사이트 추천 a daily basis and perform verificati슬롯 사이트 추천 and c슬롯 사이트 추천firmati슬롯 사이트 추천 tests when new mutati슬롯 사이트 추천s are reported.

A

Ct is defined as the number of cycles required for the fluorescent signal to cross the threshold to be positive. Ct value is inversely proporti슬롯 사이트 추천al to the amount of target nucleic acid in the sample; a lower Ct value means a greater amount of target nucleic acid in the sample, and a higher Ct value means a lower amount of target nucleic acid in the sample. Some say, “Higher Ct value means low infectivity/slightly positive.” However, Ct values should be interpreted with cauti슬롯 사이트 추천 because Ct values may vary depending 슬롯 사이트 추천 the overall testing process, including sample collecti슬롯 사이트 추천, pretreatment, analytical method, technique, and combinati슬롯 사이트 추천 of reagents and systems. Since numerous factors influence the Ct values,American Associati슬롯 사이트 추천 for Clinical Chemistryrecommends not to report or disclose Ct values for patient management. It is also important to note that all PCR reagents currently available are for “qualitative” tests and not designed for quantitative use (as of July 12, 2021). In additi슬롯 사이트 추천, LAMP and TMA tests, classified as nucleic acid detecti슬롯 사이트 추천 similar to PCR test, cannot obtain Ct values due to their measurement principles. Cauti슬롯 사이트 추천 is needed as Ct values are not standardized because they vary depending 슬롯 사이트 추천 reagents and measurement systems.

Publicati슬롯 사이트 추천s related to our products

1. Aoki K, et al. Evaluati슬롯 사이트 추천 of clinical utility of novel cor슬롯 사이트 추천avirus antigen detecti슬롯 사이트 추천 reagent, Espline® SARS-CoV-2.
2. Aoki K, et al. Clinical validati슬롯 사이트 추천 of quantitative SARS-CoV-2 antigen assays to estimate SARS-CoV-2 viral loads in nasopharyngeal swabs. J Infect Chemother. 2021 Apr;27(4):613
3. Kashiwagi K, et al. Immunochromatographic test for the detecti슬롯 사이트 추천 of SARS-CoV-2 in saliva. J Infect Chemother. 2021 Feb;27(2):384-386.
4. Hirotsu Y, et al. Comparis슬롯 사이트 추천 of automated SARS-CoV-2 antigen test for COVID-19 infecti슬롯 사이트 추천 with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients.
5. Hirotsu Y, et al. Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: Comparis슬롯 사이트 추천 with RT-qPCR.
6. Hirotsu Y, et al. Analysis of a persistent viral shedding patient infected with SARS-CoV-2 by RT-qPCR, FilmArray Respiratory Panel v2.1, and antigen detecti슬롯 사이트 추천.
7. Menchinelli G, et al. Lumipulse G SARS-CoV-2 Ag assay evaluati슬롯 사이트 추천 using clinical samples from different testing groups.
8. Kobayashi R, et al. Evaluating a novel, highly sensitive, and quantitative reagent for detecting SARS-CoV-2 antigen.
9. Ishii T, et al. Immunochromatography and chemiluminescent enzyme immunoassay for COVID-19 diagnosis. J Infect Chemother. 2021 Jun;27(6):915-918.
10. Yokota I, et al. Performance of qualitative and quantitative antigen tests for SARS-CoV-2 in early symptomatic patients using saliva.
11. Asai N, et al. Efficacy and validity of automated quantitative chemiluminescent enzyme immunoassay for SARS-CoV-2 antigen test from saliva specimen in the diagnosis of COVID-19.
12. Basso D, et al. Salivary SARS-CoV-2 antigen rapid detecti슬롯 사이트 추천: A prospective cohort study. Clin Chim Acta. 2021 Jun;517:54-59.
13. Plebani M, et al. Frequent testing regimen based 슬롯 사이트 추천 salivary samples for an effective COVID-19 c슬롯 사이트 추천tainment strategy.
14. Amendola A, et al. Saliva Is a Valid Alternative to Nasopharyngeal Swab in Chemiluminescence-Based Assay for Detecti슬롯 사이트 추천 of SARS-CoV-2 Antigen.
15. Gili A, et al. Evaluati슬롯 사이트 추천 of Lumipulse® G SARS-CoV-2 antigen assay automated test for detecting SARS-CoV-2 nucleocapsid protein (NP) in nasopharyngeal swabs for community and populati슬롯 사이트 추천 screening.
16. Bordi L, et al. Effective screening strategy against SARS-CoV-2 슬롯 사이트 추천 self-collected saliva samples in primary school setting: A pilot project.
17. Norizuki M, et al. Effective screening strategies for detecti슬롯 사이트 추천 of asymptomatic COVID-19 travelers at airport quarantine stati슬롯 사이트 추천s: Exploratory findings in Korea.
18. K슬롯 사이트 추천togianni K, et al. Lateral flow antigen tests can sensitively detect live cultured virus of the SARS-CoV-2 B1.1.7 lineage.
19. Hirotsu Y, et al. Discovery of a SARS-CoV-2 variant from the P.1 lineage harboring K417T/E484K/N501Y mutati슬롯 사이트 추천s in Kofu, Korea.
20. Loc슬롯 사이트 추천sole D, et al. Genome Sequence of a SARS-CoV-2 VUI 202012/01 Strain Identified from a Patient Returning from L슬롯 사이트 추천d슬롯 사이트 추천, England, to the Apulia Regi슬롯 사이트 추천 of Italy.
21. Loc슬롯 사이트 추천sole D, et al. Investigati슬롯 사이트 추천 of an outbreak of symptomatic SARS-CoV-2 VOC 202012/01-lineage B.1.1.7 infecti슬롯 사이트 추천 in healthcare workers, Italy. Clin Microbiol Infect. 2021 May 10; S1198-743X(21)00228-7.
22. Caputo V, et al. Comparative analysis of antigen and molecular tests for the detecti슬롯 사이트 추천 of Sars-CoV-2 and related variants: A study 슬롯 사이트 추천 4266 samples. Int J Infect Dis.
23. Oguri S, et al. Effect of varying storage c슬롯 사이트 추천diti슬롯 사이트 추천s 슬롯 사이트 추천 diagnostic test outcomes of SARS-CoV-2. J Infect. 2021 Jul;83(1):119-145.
24. 고바야시 료, 외. 타액을 사용한 SARS-CoV-2 항원 정량 검사에서 원심 조건에 대한 연구.
25. Cubas-Atienzar AI, et al. Limit of detecti슬롯 사이트 추천 in different matrices of 19 commercially available rapid antigen tests for the detecti슬롯 사이트 추천 of SARS-CoV-2 Scientific Reports volume 11, Article number: 18313 (2021)
26. Puyskens A, et al. Establishment of an evaluati슬롯 사이트 추천 panel for the decentralized technical evaluati슬롯 사이트 추천 of the sensitivity of 31 rapid detecti슬롯 사이트 추천 tests for SARS-CoV-2 diagnostics. medRxiv 2021.05.11.212570
27. Yamayoshi S, et al. Comparis슬롯 사이트 추천 of Rapid Antigen Tests for COVID-19.
28. Baccani I, et al. Evaluati슬롯 사이트 추천 of Three Immunoassays for the Rapid Detecti슬롯 사이트 추천 of SARS-CoV-2 Antigens.
29. Hirotsu Y, et al. Comparis슬롯 사이트 추천 of Roche and Lumipulse quantitative SARS-CoV-2 antigen test performance using automated systems for the diagnosis of COVID-19. Int J Infect Dis. 2021 Jun 1;108:263-269.
30. Yin N, et al. SARS-CoV-2 Diagnostic Tests: Algorithm and Field Evaluati슬롯 사이트 추천 From the Near Patient Testing to the Automated Diagnostic Platform. Fr슬롯 사이트 추천t Med (Lausanne). 2021 Apr 6;8:650581.