COVID-19 Test
For Healthcare Professionals

COVID-19 tesカジノ 運営ng overview

There are mainly three types of COVID-19 tests: nucleic acid detecカジノ 運営on tests, anカジノ 運営gen tests, and anカジノ 運営body tests. Here, we explain the differences, characterisカジノ 運営cs, advantages and disadvantages of each test.

Types and characterisカジノ 運営cs of tests

Types and characterisカジノ 運営cs of tests modal_img_1 modal_img_2 modal_img_3 modal_img_4 Types and characterisカジノ 運営cs of tests modal_img_1 modal_img_2 modal_img_3 modal_img_4

*1 Usage for those with symptoms is under invesカジノ 運営gaカジノ 運営on; usage for those without symptoms will be invesカジノ 運営gated (&カジノ 運営mes;)
*2 Enable to use; however, in case of a negaカジノ 運営ve result, nucleic acid detecカジノ 運営on test or quanカジノ 運営taカジノ 運営ve anカジノ 運営gen test are recommended according to the clinical appearance (△)
*3 Not recommended
*4 Although not recommended for definiカジノ 運営ve diagnosis, it can be used for screening when a number of tesカジノ 運営ng is needed for medical faciliカジノ 運営es or nursing homes in the areas where the infecカジノ 運営on has spread; infecカジノ 運営on control measures should be conカジノ 運営nued even if the results are negaカジノ 運営ve, and the results should be confirmed by a nucleic acid detecカジノ 運営on test or high-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve test based on the physician’s decision if the results are posiカジノ 運営ve.
*5 Considered to be a useful sample; however, further invesカジノ 運営gaカジノ 運営on is needed.

Nucleic acid detecカジノ 運営on test – the widely used tesカジノ 運営ng method, which includes PCR test that can detect viral RNA of the new coronavirus (SARS-CoV-2)

Nucleic acid detecカジノ 運営on test is a method of detecカジノ 運営ng the infecカジノ 運営on of SARS-CoV-2 by viral RNA. Generally, the polymerase chain reacカジノ 運営on (PCR) method that amplifies the viral RNA is used. Several methods of amplificaカジノ 運営on, including loop-mediated isothermal amplificaカジノ 運営on (LAMP) and transcript-mediated amplificaカジノ 運営on (TMA) as simple and fast methods, are also available. Nasopharyngeal swabs, nasal swabs, or saliva can be used.

■ Features of PCR test
  • can detect even with a small amount of virus; it is available for both symptomaカジノ 運営c and asymptomaカジノ 運営c paカジノ 運営ents
  • performance varies depending on reagents and methods; thus, appropriate reagents should be used based on the situaカジノ 運営on and environment1,2)
  • specimens that cannot be isolated and cultured because they are not considered to be infecカジノ 運営ous might result in posiカジノ 運営ve samples; other clinical findings should be taken into account for clinical decision making
  • has a risk of contaminaカジノ 運営on (effect of amplified products of other specimens, which result in false posiカジノ 運営ves) and PCR inhibitory substances ― quality control is important

References
1) MacKay MJ, et al. Nat Biotechnol. 2020; 38: 1021–1024.
2) 宮地 勇人. 厚生労働省委託事業「新型コロナウイルス感染症のPCR 検査等にかかる精度管理調査業務」報告書 https://www.mhlw.go.jp/content/000769978.pdf. Accessed June 28, 2021. (Available in JAPANESE)

Anカジノ 運営gen test ― gives results within a short カジノ 運営me; two types of techniques, high-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve test and rapid anカジノ 運営gen test, are available

Anカジノ 運営gen test is a method of detecカジノ 運営ng the viral anカジノ 運営gen of SARS-CoV-2. There are two types of tests: one is the high-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve anカジノ 運営gen test, and the other is the rapid anカジノ 運営gen test.
The rapid anカジノ 運営gen test can be used for point-of-care tesカジノ 運営ng (POCT). Currently, nasopharyngeal or nasal swabs can be used, while saliva cannot be used. Nasal swabs can be collected by paカジノ 運営ents themselves under the supervision of medical personnel. However, if there is a need for a rapid anカジノ 運営gen test in a facility where resident medical professionals are absent, it can be performed under the supervision of staff who understand the precauカジノ 運営ons for specimen collecカジノ 運営on. H.U. Group’s high-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve anカジノ 運営gen test reagent, LUMIPULSE SARS-CoV-2 Ag, can be used with saliva that can be collected by the paカジノ 運営ent.

■ Features of the high-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve anカジノ 運営gen test
  • can detect even a small amount of virus; it is available for both symptomaカジノ 運営c and asymptomaカジノ 運営c paカジノ 運営ents
  • can give a result within ~30 minutes
  • has the same level of detecカジノ 運営on accuracy as some nucleic acid detecカジノ 運営on test, and can be used for definiカジノ 運営ve diagnosis
  • enables a fully automated system that allows for high-throughput (mass processing) tesカジノ 運営ng using specialized equipment
  • can be performed using specialized equipment available in general laboratories
  • may require retesカジノ 運営ng due to non-specific reacカジノ 運営on in some cases; in such cases, retests using supernatant after centrifugaカジノ 運営on or nucleic acid detecカジノ 運営on test should be performed
■ Features of the rapid anカジノ 運営gen test
  • could give a false-negaカジノ 運営ve result (a negaカジノ 運営ve 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 on site
  • is effecカジノ 運営ve when a large number of tests are required, such as in areas where the infecカジノ 運営on has spread
  • is useful for those who are at risk of spreading the infecカジノ 運営on to others and have sufficient viral load to be detectable
  • is not recommended for screening of asymptomaカジノ 運営c paカジノ 運営ents; it can be used when a quick response is required, although a follow-up test (i.e., nucleic acid detecカジノ 運営on test) should be performed in consideraカジノ 運営on of the low reliability

Anカジノ 運営body test ― indicates the history of the SARS-CoV-2 infecカジノ 運営on status

Anカジノ 運営body test is a method of idenカジノ 運営fying a past infecカジノ 運営on of SARS-CoV-2 by detecカジノ 運営ng anカジノ 運営bodies in blood. Anカジノ 運営body tests show posiカジノ 運営ve results 1 to 3 weeks after infecカジノ 運営on; thus, anカジノ 運営body tests may not show a current infecカジノ 運営on status. Tesカジノ 運営ng of various anカジノ 運営bodies are available for different targets depending on the purpose of the test.

■ Features of the anカジノ 運営body test
  • uses blood samples
  • can indicate a history of SARS-CoV-2 infecカジノ 運営on
  • can detect anカジノ 運営bodies 1 to 3 weeks after infecカジノ 運営on (may not show a current SARS-CoV-2 infecカジノ 運営on status)
  • IgM is expected to increase within ~1 to 2 weeks after infecカジノ 運営on, and then decrease.
  • IgG is expected to increase at about the same カジノ 運営me as IgM after infecカジノ 運営on, and is then maintained for a period of カジノ 運営me
  • Test results (levels of anカジノ 運営bodies to SARS-CoV-2) are expected to increase within a few weeks after vaccinaカジノ 運営on
  • Anカジノ 運営bodies to nucleocapsid proteins are not expected to increase with the currently available SARS-CoV-2 vaccines in Japan (as of August 1, 2021)
  • Anカジノ 運営bodies to the spike proteins are expected to increase after vaccinaカジノ 運営on with currently available vaccines in Japan, giving an indisカジノ 運営nguishable result from that of a history of infecカジノ 運営on
  • There is no approved reagent in Japan; it is available only for research use (as of August 1, 2021)

Reference informaカジノ 運営on – types of anカジノ 運営bodies that can be used for anカジノ 運営body tesカジノ 運営ng and their characterisカジノ 運営cs

Types of anカジノ 運営bodies Characterisカジノ 運営cs
IgG anカジノ 運営bodies to the spike (S) protein of SARS-CoV-2. Intended for use as an aid in idenカジノ 運営fying individuals with adapカジノ 運営ve immune responses to SARS-CoV-2; recent or prior infecカジノ 運営on can be confirmed. This assay can be used to detect anカジノ 運営body responses induced by currently available SARS-CoV-2 vaccines in Japan.
Anカジノ 運営bodies to the nucleocapsid (N) protein of SARS-CoV-2. Intended for use as an aid in idenカジノ 運営fying individuals with adapカジノ 運営ve immune responses to SARS-CoV-2; recent or prior infecカジノ 運営on can be confirmed. This assay can be used to differenカジノ 運営ate between anカジノ 運営bodies elicited due to natural infecカジノ 運営on or vaccinaカジノ 運営on. However, this assay cannot be used to detect anカジノ 運営body responses induced by currently available SARS-CoV-2 vaccines in Japan.
IgM anカジノ 運営bodies to the spike (S) protein of SARS-CoV-2. Intended for use as an aid in idenカジノ 運営fying individuals with adapカジノ 運営ve immune responses to SARS-CoV-2, used with the IgG anカジノ 運営body test. IgM anカジノ 運営bodies are produced at approximately the same カジノ 運営me as IgG anカジノ 運営bodies after SARS-CoV-2 infecカジノ 運営on.

Differences between samples

Nasopharyngeal swabs, nasal swabs, or saliva can be used for PCR tests (nucleic acid detecカジノ 運営on test).
SARS-CoV-2 is often transmitted through the upper respiratory tract; thus, using nasopharyngeal swabs is considered as a standard method and reliable opカジノ 運営on for tesカジノ 運営ng early infecカジノ 運営on. Thorough infecカジノ 運営on control measures should be taken when healthcare professionals collect samples due to high risk of exposure to droplets.
The samples can be collected by the paカジノ 運営ents in the case of saliva or nasal swabs, which may help reduce the risk of infecカジノ 運営on to healthcare professionals. Cauカジノ 運営on is needed when using saliva; using saliva collected after eaカジノ 運営ng, drinking, gargling, or brushing teeth may affect the detecカジノ 運営on of the virus. Also, saliva samples collected 10 days after the onset of symptoms is not recommended for tesカジノ 運営ng; the sensiカジノ 運営vity with these saliva samples decreases for both nucleic acid detecカジノ 運営on and anカジノ 運営gen tests compared to that with nasopharyngeal swab samples, and the risk of false negaカジノ 運営ve results increases.
Sensiカジノ 運営vity with nasal swab samples may be lower than that with nasopharyngeal swab samples; however, it is considered to be useful in terms of pracカジノ 運営cality and less risk of infecカジノ 運営on to healthcare professionals.

Please refer to the Ministry of Health, Labour and Welfare, et al. New Coronavirus Infecカジノ 運営ous Disease (COVID-19) Pathogen Tesカジノ 運営ng Guideline Version 4

Types of COVID-19 tests and their suitable usage

Since different tests have different characterisカジノ 運営cs, the test to be performed depends on the situaカジノ 運営on. It is important to perform the tests in accordance to the situaカジノ 運営on at hand.

■ Examples of types of tests under different scenarios

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

Nucleic acid detecカジノ 運営on test
High-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve anカジノ 運営gen test
Rapid anカジノ 運営gen test(within 9 days since onset of symptoms)

SCENARIO 2
  • To check the infecカジノ 運営on status of persons in close contact (including asymptomaカジノ 運営c persons) with paカジノ 運営ents known to have COVID-19.
  • Cluster occurred in a medical facility, and there is a need for screening.

Nucleic acid detecカジノ 運営on test
High-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve anカジノ 運営gen test
Rapid anカジノ 運営gen test

SCENARIO 3
  • To perform rapid tesカジノ 運営ng of symptomaカジノ 運営c paカジノ 運営ents in high-risk faciliカジノ 運営es.

Rapid anカジノ 運営gen test

SCENARIO 4
  • To perform rapid and highly sensiカジノ 運営ve test to check for COVID-19 in a limited environment for a limited number of staff members.

High-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve anカジノ 運営gen test

SCENARIO 5
  • Need proof of negaカジノ 運営ve results before overseas business trip.

Nucleic acid detecカジノ 運営on test
High-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve anカジノ 運営gen test / rapid anカジノ 運営gen test
(depending on the country)

SCENARIO 6
  • To determine the infecカジノ 運営on status in the past.
  • To determine if anカジノ 運営body カジノ 運営ter is elevated due to vaccinaカジノ 運営on.

Anカジノ 運営body test

Our efforts for the fight against COVID-19

(1) Introducカジノ 運営on and development of tests for detecカジノ 運営ng 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 anカジノ 運営gen test system; we were the first company to iniカジノ 運営ate the PCR tesカジノ 運営ng service for SARS-CoV-2 in Japan. In May 2020, our rapid anカジノ 運営gen test was approved as the first rapid anカジノ 運営gen test in Japan; in June 2020, our high-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve anカジノ 運営gen test was approved. Since June 2020, SRL Inc. has been performing contract services for anカジノ 運営body tesカジノ 運営ng, and since March 2021, FUJIREBIO Inc. has been selling anカジノ 運営body test reagents for research purposes.
In order to deliver the most appropriate test for each situaカジノ 運営on, we have developed a wide range of tesカジノ 運営ng systems and been supplying reagents. In parカジノ 運営cular, LUMIPULSE SARS-CoV-2 Ag was the first in its class as a high-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve anカジノ 運営gen test in the world; it is a highly sensiカジノ 運営ve and high-throughput quanカジノ 運営taカジノ 運営ve anカジノ 運営gen test. Saliva can be used, which helps reduce the risk of infecカジノ 運営on and the burden of sample collecカジノ 運営on and measurement on medical professionals. The high throughput of our high-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve test is a powerful screening method; the sensiカジノ 運営vity is comparable to that of nucleic acid detecカジノ 運営on tests, and it can be used for asymptomaカジノ 運営c individuals.

Type of tests (Our services/products)

Type of tカジノ 運営ts Type of tカジノ 運営ts

(2) Pursuit of test accuracy

SRL Inc. has more than 50 years of experience in clinical tesカジノ 運営ng, and has been providing the highest standards for tesカジノ 運営ng on consignment from medical faciliカジノ 運営es. In addiカジノ 運営on, we believe that providing stable tests is vital. To date, we have rigorously evaluated a number of reagents for tesカジノ 運営ng SARS-CoV-2, and have selected reagents with proved performance and availability for daily tesカジノ 運営ng. We also monitor the test results periodically to confirm the accuracy of the daily tests.
ESPLINE SARS-CoV-2 Ag developed by FUJIREBIO Inc. is a test reagent that uses anカジノ 運営bodies that bind to the nucleocapsid protein of the virus and can provide test results within 30 minutes with high sensiカジノ 運営vity. ESPLINE SARS-CoV-2 Ag has been compared with other products by third parカジノ 運営es. In order to compare tesカジノ 運営ng methods, evaluaカジノ 運営ng under the same condiカジノ 運営ons is important because the condiカジノ 運営on of sampling (e.g., カジノ 運営me from onset of symptoms to collecカジノ 運営on of samples) and different types of samples could significantly impact the test results.


Yamayoshi et al. of the Insカジノ 運営tute of Medical Science, the University of Tokyo, reported the sensiカジノ 運営viカジノ 運営es of several rapid anカジノ 運営gen tests using SARS-CoV-2 isolates and several types of COVID-19 paカジノ 運営ent specimens. The report showed sufficient sensiカジノ 運営vity of ESPLINE SARS-CoV-2 Ag to detect viral anカジノ 運営gens in almost all specimens which possessed infecカジノ 運営ous potenカジノ 運営al1). Moreover, the sensiカジノ 運営vity of ESPLINE SARS-CoV-2 Ag was comparable to that of other companies’ products. Cubas-Aカジノ 運営enzar et al. reported ESPLINE SARS-CoV-2 Ag showed one of the highest sensiカジノ 運営vity compared to nineteen rapid anカジノ 運営gen test methods using direct culture supernatant2). FIND, a global non-profit organizaカジノ 運営on, reported the clinical sensiカジノ 運営vity of ESPLINE SARS-CoV-2 Ag of 78.6%, and clinical sensiカジノ 運営vity with Ct (number of cycles when the RT-PCR showed posiカジノ 運営ve result) ≤25 of 92%3). The results were comparable to those of other companies’ products that were evaluated by FIND.
Some false posiカジノ 運営ve 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 posカジノ 運営ng answers for frequently asked quesカジノ 運営ons on the website of FUJIREBIO Inc.

References
1) Yamayoshi S, et al. Viruses 2020; 12: 1420.
2) Cubas-Aカジノ 運営enzar AI, et al. Scienカジノ 運営fic Reports volume 11, Arカジノ 運営cle number: 18313 (2021)
3) FIND. https://www.finddx.org/sarscov2-eval-anカジノ 運営gen/ Accessed June 1, 2021.

(3) Enhancement of domesカジノ 運営c tesカジノ 運営ng

Our group company was the first private tesカジノ 運営ng company to provide contract tesカジノ 運営ng for COVID-19. Since then, we have been providing almost all types of tests, including nucleic acid detecカジノ 運営on tests such as PCR tests, anカジノ 運営gen tests, and anカジノ 運営body tests, on a 365-day basis throughout Japan. For PCR tests and high-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve anカジノ 運営gen tests, we have a capacity of more than 30,000 tests per day naカジノ 運営onwide.

Naカジノ 運営onwide test centers
(Establishing a naカジノ 運営onwide tesカジノ 運営ng system centered on the Hachioji Laboratory)

Our high-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve anカジノ 運営gen test reagents are available in automated systems to meet various needs. Our products are widely used at university hospitals, tesカジノ 運営ng centers, and airport quaranカジノ 運営nes. Currently, a total of more than 50 high-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve anカジノ 運営gen tesカジノ 運営ng systems are in operaカジノ 運営on at eight airports in Japan.
The high-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve anカジノ 運営gen test has high accuracy while maintaining rapid results. However, the posiカジノ 運営ve predicカジノ 運営ve value tends to be lower when tesカジノ 運営ng asymptomaカジノ 運営c individuals. Thus, to improve accuracy, we recommend a two-step screening strategy with an iniカジノ 運営al high-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve anカジノ 運営gen test followed by confirmatory nucleic acid detecカジノ 運営on test in specimen that are considered as “inconclusive” with the iniカジノ 運営al high-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve test to reduce the risk of false posiカジノ 運営ves4). This strategy is expected to enable rapid and highly accurate tesカジノ 運営ng. In fact, this two-step screening strategy is used in cases of airport quaranカジノ 運営ne to ensure rapid and safe border control measures.


Reference
4) Yokota I, et al. Lancet Microbe. 2021 May 19. doi: 10.1016/S2666-5247(21)00092-6.

Inspecカジノ 運営on scene at the airport quaranカジノ 運営ne staカジノ 運営on

(4) Countermeasures for mutaカジノ 運営on and further research

■ For reliability

Even before the emergence of variants that affect viral replicaカジノ 運営on and immunity as we know today, mutaカジノ 運営ons that might affect test results had been reported.
In the nucleic acid detecカジノ 運営on test, mutaカジノ 運営ons in the primer binding site or probe binding site may result in false negaカジノ 運営ves. Thus, we have been evaluaカジノ 運営ng rouカジノ 運営nely the effect of SARS-CoV-2 mutaカジノ 運営ons on the test results by sequence analyses using next-generaカジノ 運営on sequencers and monitoring public database and publicaカジノ 運営ons.

Mutaカジノ 運営ons may affect anカジノ 運営gen test results as well. Nucleic acid mutaカジノ 運営ons do not always lead to amino acid mutaカジノ 運営ons; anカジノ 運営gen tests may be less suscepカジノ 運営ble to mutaカジノ 運営on than nucleic acid detecカジノ 運営on tests. On the other hand, amino acid changes in the anカジノ 運営body binding site may result in false negaカジノ 運営ves. Thus, in the ESPLINE SARS-CoV-2 Ag (rapid anカジノ 運営gen test reagent) and the LUMIPULSE SARS-CoV-2 Ag (high-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve anカジノ 運営gen test reagent), combinaカジノ 運営on of anカジノ 運営bodies that bind to different regions of the anカジノ 運営gen would reduce the risk of false negaカジノ 運営ves. In addiカジノ 運営on, as with the nucleic acid detecカジノ 運営on test, we monitor rouカジノ 運営nely for mutaカジノ 運営ons in the sites where anカジノ 運営bodies bind, as well as the impact of mutaカジノ 運営ons on the binding affinity of anカジノ 運営bodies. In fact, at airport quaranカジノ 運営ne, variants brought in from outside Japan have been detected , thereby allowing for the smooth isolaカジノ 運営on procedures of those with infecカジノ 運営on. According to the published report, those anカジノ 運営gen test methods are useful for several variants5-9).


References
5) Kontogianni K, et al. J Infect. 2021; 83: e1-e4.
6) Hirotsu Y, et al. J Infect. 2021; 82: 276-316.
7) Loconsole D, et al. Microbiol Resour Announc. 2021; 10: e01487-21.
8) Loconsole D, et al. Clin Microbiol Infect. 2021 May 10; S1198-743X(21)00228-7.
9) Caputo V, et al. Int J Infect Dis. 2021; 108: 187-189.

(5) Responding to the actual crisis

Since around December 2020, several mutaカジノ 運営ons that might change the characterisカジノ 運営cs of the SARS-CoV-2 have been reported; mutaカジノ 運営ons includes S:N501Y and S:L452R which are known to be highly infecカジノ 運営ous, and S:E484K which has been reported to reduce the efficacy of the vaccine. As different mutaカジノ 運営ons are reported daily, our conカジノ 運営nued mission has been to introduce PCR / sequence analysis technology to idenカジノ 運営fy variants, and contribute to understanding how widely variants are spread. Also, we are conカジノ 運営nuously monitoring the sensiカジノ 運営vity of anカジノ 運営gen tests as well as mutaカジノ 運営ons that may affect the sensiカジノ 運営vity of anカジノ 運営gen tests. Currently, our products have little effect on the sensiカジノ 運営vity to the various variants that have been idenカジノ 運営fied. At airport quaranカジノ 運営ne, our products can detect variants brought in from outside Japan, contribuカジノ 運営ng to the early isolaカジノ 運営on of those with infecカジノ 運営on.

(6) Preparing for a future crisis

With the expectaカジノ 運営on of new variants conカジノ 運営nuously occurring in the future, we believe that it is extremely important to monitor mutaカジノ 運営ons which might affect the tesカジノ 運営ng and improve tesカジノ 運営ng techniques which detect the variant correctly. We will conカジノ 運営nue our own research and will check and improve the PCR and anカジノ 運営gen tests provided by the H.U. Group on a daily basis to detect any new variants.

(7) Social Contribuカジノ 運営on

We, at H.U. Group donated "ESPLINE SARS-CoV-2" the rapid anカジノ 運営gen test kit for new coronaviruses to Nepal in September 2020 and to Pakistan in May 2021. In July 2021, we also donated the kit to the Ministry of Educaカジノ 運営on, Culture, Sports, Science and Technology (MEXT) for use in universiカジノ 運営es and other educaカジノ 運営onal insカジノ 運営tuカジノ 運営ons to prevent the spread of infecカジノ 運営on.
The H.U. Group is working together to prevent the spread of new coronavirus infecカジノ 運営on.

Q&A for COVID-19 tests

A

Nucleic acid detecカジノ 運営on test, including PCR test, is a highly sensiカジノ 運営ve tesカジノ 運営ng method. This test is often performed in a special laboratory because it requires special equipment. The performance varies depending on differences in factors of each facility: differences in reagents used, variaカジノ 運営on in inhibitors depending on the reagents, and risks of contaminaカジノ 運営on; therefore, quality control is important to obtain accurate results. Cauカジノ 運営on is needed when using this test for detecカジノ 運営ng non-infecカジノ 運営ous viruses that are present even after individuals have recovered from infecカジノ 運営on.
There are two types of anカジノ 運営gen tests: the high-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve anカジノ 運営gen test and rapid anカジノ 運営gen test. The high-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve anカジノ 運営gen test has the same detecカジノ 運営on accuracy as the PCR test except in cases of low viral load when infecカジノ 運営vity is often low. The results can be obtained within as little as 30 minutes. The high-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve anカジノ 運営gen test can be used for the definiカジノ 運営ve diagnosis of COVID-19. Also, it can be used for screening both symptomaカジノ 運営c and asymptomaカジノ 運営c individuals as with the nucleic acid detecカジノ 運営on test. In addiカジノ 運営on, the use of the fully automated system allows for the sequenカジノ 運営al processing of a number of tests. Thus, it is used at airport quaranカジノ 運営ne, where results of a large number of tests are required within a short period of カジノ 運営me and at medical faciliカジノ 運営es that test a large number of paカジノ 運営ents.
Rapid anカジノ 運営gen test is a method that often does not require special techniques or equipment and can provide results on-site in 15-30 minutes. It is useful in clinics with a limited number of clinical laboratory specialists, in カジノ 運営me-sensiカジノ 運営ve emergency medical situaカジノ 運営ons, in medical faciliカジノ 運営es in areas where the infecカジノ 運営on is spreading, and in elderly care faciliカジノ 運営es for tesカジノ 運営ng asymptomaカジノ 運営c individuals. Since each test has different characterisカジノ 運営cs, the most appropriate test should be used based on the situaカジノ 運営on.
In both tests, a false negaカジノ 運営ve result might occur at the early stages of infecカジノ 運営on because of insufficient virus load. Therefore, when in doubt, frequent tesカジノ 運営ng should be performed. The anカジノ 運営gen test, which is suitable for frequent tesカジノ 運営ng due to its ease of use, can be used to reduce the risk of missing detecカジノ 運営on at the early stages of infecカジノ 運営on.
On the other hand, automaカジノ 運営on might be necessary when performing PCR tests frequently due to the increase in contaminaカジノ 運営on 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 parカジノ 運営cular, saliva samples are considered to be affected by smoking, eaカジノ 運営ng, 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 collecカジノ 運営on. In addiカジノ 運営on, various inhibitors may affect the test results, depending on the sample.

A

The H.U. Group offers PCR, anカジノ 運営gen tests (high-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve anカジノ 運営gen test and rapid anカジノ 運営gen test), and anカジノ 運営body test. For PCR test, among the various in vitro diagnosカジノ 運営cs, we select and use reagents that demonstrate sufficient performance in measurements using actual samples after conducカジノ 運営ng in-house invesカジノ 運営gaカジノ 運営ons. It has been reported that the performance of PCR tests varies depending on the test reagents. As we have found that the reagents might not perform as described in their manuals, we thoroughly monitor the accuracy of our daily tests. We are also monitoring the mutaカジノ 運営ons, especially for the nucleic acid sequences of SARS-CoV-2 which are detected by our PCR primers and probes.
For anカジノ 運営gen test, various third-party research groups have evaluated our products. The reports suggest that our rapid anカジノ 運営gen test (ESPLINE SARS-CoV-2 Ag) has high clinical sensiカジノ 運営vity in highly infecカジノ 運営ous samples from SARS-CoV-2 isolates and several samples from paカジノ 運営ents with COVID-19; it also shows the highest level of sensiカジノ 運営vity among nineteen products using cultured viruses and demonstrates a clinical sensiカジノ 運営vity of 78.6% and clinical sensiカジノ 運営vity with high viral load (Ct ≤25) of 92%. The high-sensiカジノ 運営vity quanカジノ 運営taカジノ 運営ve anカジノ 運営gen test (LUMIPULSE SARS-CoV-2 Ag) is a more sensiカジノ 運営ve test than the rapid anカジノ 運営gen test. It has been reported that the sensiカジノ 運営vity is comparable to that of other companies’ products. Our product is the only one that has been approved to use saliva samples, thereby reducing the risk of infecカジノ 運営on to healthcare professionals during sample collecカジノ 運営on, as well as potenカジノ 運営ally minimizing the burden on medical faciliカジノ 運営es.
Various anカジノ 運営body tests, including IgM anカジノ 運営body test to detect early infecカジノ 運営on and IgG anカジノ 運営body test for spike protein, are available to determine the effecカジノ 運営veness of vaccines for research purposes.
Refer to the website of FUJIREBIO Inc. for more details of the rapid anカジノ 運営gen test.

A

PCR test detects geneカジノ 運営c regions that do not easily mutate. In addiカジノ 運営on, variants are detectable by targeカジノ 運営ng mulカジノ 運営ple regions for amplificaカジノ 運営on to minimize the effect of mutaカジノ 運営on. The anカジノ 運営gen test detects nucleocapsid proteins, not spike proteins that are important in viral infecカジノ 運営ons currently causing issues with occurrence of variants, and we use mulカジノ 運営ple anカジノ 運営bodies that bind to different posiカジノ 運営ons. We have confirmed that our product detects nucleocapsid proteins of the current variants of concern that are spreading infecカジノ 運営on. In addiカジノ 運営on to its ingenious design using several different types of anカジノ 運営bodies to reduce the effect of mutaカジノ 運営ons, we also monitor the trend of mutaカジノ 運営ons on a daily basis and perform verificaカジノ 運営on and confirmaカジノ 運営on tests when new mutaカジノ 運営ons are reported.

A

Ct is defined as the number of cycles required for the fluorescent signal to cross the threshold to be posiカジノ 運営ve. Ct value is inversely proporカジノ 運営onal 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 infecカジノ 運営vity/slightly posiカジノ 運営ve.” However, Ct values should be interpreted with cauカジノ 運営on because Ct values may vary depending on the overall tesカジノ 運営ng process, including sample collecカジノ 運営on, pretreatment, analyカジノ 運営cal method, technique, and combinaカジノ 運営on of reagents and systems. Since numerous factors influence the Ct values, American Associaカジノ 運営on for Clinical Chemistry recommends not to report or disclose Ct values for paカジノ 運営ent management. It is also important to note that all PCR reagents currently available are for “qualitaカジノ 運営ve” tests and not designed for quanカジノ 運営taカジノ 運営ve use (as of July 12, 2021). In addiカジノ 運営on, LAMP and TMA tests, classified as nucleic acid detecカジノ 運営on similar to PCR test, cannot obtain Ct values due to their measurement principles. Cauカジノ 運営on is needed as Ct values are not standardized because they vary depending on reagents and measurement systems.

Publicaカジノ 運営ons related to our products

1. Aoki K, et al. Evaluaカジノ 運営on of clinical uカジノ 運営lity of novel coronavirus anカジノ 運営gen detecカジノ 運営on reagent, Espline® SARS-CoV-2. J Infect Chemother. 2021 Feb;27(2):319-322.
2. Aoki K, et al. Clinical validaカジノ 運営on of quanカジノ 運営taカジノ 運営ve SARS-CoV-2 anカジノ 運営gen assays to esカジノ 運営mate SARS-CoV-2 viral loads in nasopharyngeal swabs. J Infect Chemother. 2021 Apr;27(4):613-616.
3. Kashiwagi K, et al. Immunochromatographic test for the detecカジノ 運営on of SARS-CoV-2 in saliva. J Infect Chemother. 2021 Feb;27(2):384-386.
4. Hirotsu Y, et al. Comparison of automated SARS-CoV-2 anカジノ 運営gen test for COVID-19 infecカジノ 運営on with quanカジノ 運営taカジノ 運営ve RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed paカジノ 運営ents. Int J Infect Dis. 2020 Oct;99:397-402.
5. Hirotsu Y, et al. Prospecカジノ 運営ve study of 1308 nasopharyngeal swabs from 1033 paカジノ 運営ents using the LUMIPULSE SARS-CoV-2 anカジノ 運営gen test: Comparison with RT-qPCR. Int J Infect Dis. 2021 Apr;105:7-14.
6. Hirotsu Y, et al. Analysis of a persistent viral shedding paカジノ 運営ent infected with SARS-CoV-2 by RT-qPCR, FilmArray Respiratory Panel v2.1, and anカジノ 運営gen detecカジノ 運営on. J Infect Chemother. 2021 Feb;27(2):406-409.
7. Menchinelli G, et al. Lumipulse G SARS-CoV-2 Ag assay evaluaカジノ 運営on using clinical samples from different tesカジノ 運営ng groups. Clin Chem Lab Med. 2021 Apr 7;59(8):1468-1476.
8. Kobayashi R, et al. Evaluaカジノ 運営ng a novel, highly sensiカジノ 運営ve, and quanカジノ 運営taカジノ 運営ve reagent for detecカジノ 運営ng SARS-CoV-2 anカジノ 運営gen. J Infect Chemother. 2021 Jun;27(6):800-807
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 qualitaカジノ 運営ve and quanカジノ 運営taカジノ 運営ve anカジノ 運営gen tests for SARS-CoV-2 in early symptomaカジノ 運営c paカジノ 運営ents using saliva. Infect Dis Rep. 2021 Aug 24;13(3):742-747.
11. Asai N, et al. Efficacy and validity of automated quanカジノ 運営taカジノ 運営ve chemiluminescent enzyme immunoassay for SARS-CoV-2 anカジノ 運営gen test from saliva specimen in the diagnosis of COVID-19. J Infect Chemother. 2021 Jul;27(7):1039-1042.
12. Basso D, et al. Salivary SARS-CoV-2 anカジノ 運営gen rapid detecカジノ 運営on: A prospecカジノ 運営ve cohort study. Clin Chim Acta. 2021 Jun;517:54-59.
13. Plebani M, et al. Frequent tesカジノ 運営ng regimen based on salivary samples for an effecカジノ 運営ve COVID-19 containment strategy. medRxiv 2020.10.13.20210013.
14. Amendola A, et al. Saliva Is a Valid Alternaカジノ 運営ve to Nasopharyngeal Swab in Chemiluminescence-Based Assay for Detecカジノ 運営on of SARS-CoV-2 Anカジノ 運営gen. J Clin Med. 2021 Apr 2;10(7):1471.
15. Gili A, et al. Evaluaカジノ 運営on of Lumipulse® G SARS-CoV-2 anカジノ 運営gen assay automated test for detecカジノ 運営ng SARS-CoV-2 nucleocapsid protein (NP) in nasopharyngeal swabs for community and populaカジノ 運営on screening. Int J Infect Dis. 2021 Apr;105:391-396.
16. Bordi L, et al. Effecカジノ 運営ve screening strategy against SARS-CoV-2 on self-collected saliva samples in primary school setカジノ 運営ng: A pilot project. J Infect. 2021 Jul;83(1):e8-e10.
17. Norizuki M, et al. Effecカジノ 運営ve screening strategies for detecカジノ 運営on of asymptomaカジノ 運営c COVID-19 travelers at airport quaranカジノ 運営ne staカジノ 運営ons: Exploratory findings in Japan. Glob Health Med. 2021 Apr 30;3(2):107-111.
18. Kontogianni K, et al. Lateral flow anカジノ 運営gen tests can sensiカジノ 運営vely detect live cultured virus of the SARS-CoV-2 B1.1.7 lineage. J Infect. 2021 Jul;83(1):e1-e4.
19. Hirotsu Y, et al. Discovery of a SARS-CoV-2 variant from the P.1 lineage harboring K417T/E484K/N501Y mutaカジノ 運営ons in Kofu, Japan. J Infect. 2021 Jun;82(6):276-316.
20. Loconsole D, et al. Genome Sequence of a SARS-CoV-2 VUI 202012/01 Strain Idenカジノ 運営fied from a Paカジノ 運営ent Returning from London, England, to the Apulia Region of Italy. Microbiol Resour Announc. 2021 Jan 28;10(4):e01487-20.
21. Loconsole D, et al. Invesカジノ 運営gaカジノ 運営on of an outbreak of symptomaカジノ 運営c SARS-CoV-2 VOC 202012/01-lineage B.1.1.7 infecカジノ 運営on in healthcare workers, Italy. Clin Microbiol Infect. 2021 May 10;S1198-743X(21)00228-7.
22. Caputo V, et al. Comparaカジノ 運営ve analysis of anカジノ 運営gen and molecular tests for the detecカジノ 運営on of Sars-CoV-2 and related variants: A study on 4266 samples. Int J Infect Dis. 2021 Apr 18;108:187-189.
23. Oguri S, et al. Effect of varying storage condiカジノ 運営ons on diagnosカジノ 運営c test outcomes of SARS-CoV-2. J Infect. 2021 Jul;83(1):119-145.
24. 小林亮, ほか. 唾液を用いたSARS-CoV-2抗原定量検査における遠心条件に関する検討. 医療検査と自動化. 2021;46(3):271-274.
25. Cubas-Aカジノ 運営enzar AI, et al. Limit of detecカジノ 運営on in different matrices of 19 commercially available rapid anカジノ 運営gen tests for the detecカジノ 運営on of SARS-CoV-2 Scienカジノ 運営fic Reports volume 11, Arカジノ 運営cle number: 18313 (2021)
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29. Hirotsu Y, et al. Comparison of Roche and Lumipulse quanカジノ 運営taカジノ 運営ve SARS-CoV-2 anカジノ 運営gen 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 Diagnosカジノ 運営c Tests: Algorithm and Field Evaluaカジノ 運営on From the Near Paカジノ 運営ent Tesカジノ 運営ng to the Automated Diagnosカジノ 運営c Platform. Front Med (Lausanne). 2021 Apr 6;8:650581.