EN

Substrate Solution is added and mixed with the

Read this insert carefully before performing the assay and make sure Enzyme Reaction
particles. AMPPD* contained in the Substrate
you are using the most recent version of the package insert.
Solution is dephosphorylated by the catalysis of
The reliability of assay procedures other than those described in this
ALP indirectly conjugated to particles.
package insert cannot be guaranteed.
Luminescence (at a maximum wavelength of 477
L2B01TE KEY-CODE: FRI50944 Luminescence
Measurement nm) is generated by the cleavage reaction of
In Vitro Diagnostic Use Aug. 2020 (ver.1) dephosphorylated AMPPD. The luminescent
signal reflects the amount of SARS-CoV-2 antigen
present in samples.
Chemiluminescent Enzyme Immunoassay Reagent
* AMPPD: 3-(2’-spiroadamantane)-4-methoxy-4-(3”-phosphoryloxy)
phenyl-1, 2-dioxetane disodium salt

¢  MATERIALS PROVIDED
Immunoreaction Cartridges Lumipulse G SARS-CoV-2 Ag Immunoreaction Cartridges: IRC
3 × 14 Tests REF 260340
1) Antibody-Coated Particle Solution
¢ NAME (Liquid when used, 150 μL/Immunoreaction Cartridge)
Lumipulse G SARS-CoV-2 Ag Immunoreaction Cartridges Contains anti-SARS-CoV-2 monoclonal antibodies (mouse)-coated
(Also referred to as ‘SARS-CoV-2 Ag Cartridges’ in this package insert) ferrite particles in Tris buffer. This solution contains gelatin and turns
into gel at 15 °C or lower. Preservative: sodium azide
¢  INTENDED USE 2) Enzyme-Labeled Antibody Solution
For in vitro diagnostic use with the LUMIPULSE G System for the (Liquid, 250 μL/Immunoreaction Cartridge)
quantitative measurement of SARS-CoV-2 antigen in human nasopharyngeal Contains alkaline phosphatase (ALP)-labeled anti-SARS-CoV-2
swab fluid or saliva. SARS-CoV-2 antigen measurement is an aid in the antibodies (mouse) in MES buffer. Preservative: sodium azide
diagnosis of COVID-19. This product is for professional use only. 3) Sample Treatment Solution
(Liquid, 120 μL/Immunoreaction Cartridge)
¢  SUMMARY AND EXPLANATION OF THE ASSAY Contains detergent in MES buffer. Preservative: sodium azide
The 2019 novel coronavirus infection disease (COVID-19) is caused by the
novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).1,2)
In December 2019, the Health Commission of the City of Wuhan, Hubei
Province, China, reported multiple pneumonia patients with unknown
cause. On January 7th 2020, the World Health Organization (WHO) Enzyme-Labeled
Antibody Solution
announced that the National Health Commission of China identified a
new type of coronavirus, SARS-CoV-2.3) The WHO declared a COVID-
Sample Treatment Solution
19 pandemic on March 11th 2020 due to the worldwide spread of novel
coronavirus infection.4)
To detect the virus, lower respiratory tract specimen, nasopharyngeal
swab fluid and saliva of the patient are shown to be reliable samples for ¢  MATERIALS REQUIRED BUT PROVIDED SEPARATELY
the detection of the SARS-CoV-2 virus.5, 6) In general, the diagnosis of 1. Lumipulse G SARS-CoV-2 Ag Calibrators set: CAL SET ,
SARS-CoV-2 infection is made by molecular detection of the SARS-CoV-2 4 × 4 Concentrations REF 231869
genes. Although nucleic acid-based tests can detect SARS-CoV-2 gene CAL Calibrators: Lyophilized,
with high sensitivity, it is restricted by the needs of special equipment and
0 pg/mL SARS-CoV-2 Ag calibrator (4 × ( 0.5 mL))
turnaround time. Lumipulse G SARS-CoV-2 Ag is useful as a diagnostic
tool for the confirmation of a SARS-CoV-2 infection by detecting the 50 pg/mL SARS-CoV-2 Ag calibrator (4 × ( 0.5 mL))
SARS-CoV-2 antigen. 1000 pg/mL SARS-CoV-2 Ag calibrator (4 × ( 0.5 mL))
5000 pg/mL SARS-CoV-2 Ag calibrator (4 × ( 0.5 mL))
¢  PRINCIPLE OF THE PROCEDURE
Lumipulse G SARS-CoV-2 Ag is an assay system, including a set of Contains SARS-CoV-2 antigen ( ~ CAL 4 ) in MES buffer
immunoassay reagents, for the quantitative measurement of SARS-CoV-2 with a protein stabilizer (bovine). Preservative: 0.1% ProClin 300
antigen in specimens based on CLEIA technology7) by a specific two-step
immunoassay method on the LUMIPULSE G System. RS Reconstituting Solution: Liquid, 1×10 mL
Preservative: sodium azide
<Reaction Protocol; Specific Two-Step Mode>
Traceability
Reagent/Specimen Set
Calibration of the Lumipulse G SARS-CoV-2 Ag is traceable to
SARS-CoV-2 virus N antigen prepared by research of Japan Agency
of Medical Research and Development (AMED) contributing to the
First Reaction
Specimen or SARS-CoV-2 Ag calibrator and development of diagnostic tests for novel coronavirus disease (2019-
Sample Treatment Solution are added to the nCOV).
Antibody-Coated Particle Solution, and mixed.
SARS-CoV-2 antigen in specimens specifically 2. Lumipulse SARS-CoV-2 Ag Sample Extraction Solution set for
binds to anti-SARS-CoV-2 monoclonal antibodies Nasopharynx swab:
(mouse) on the particles, and antigen-antibody 20 Tests REF 231883
immunocomplexes are formed.
SES Sample Extraction Solution: Liquid, 1 × 9 mL
Washing The particles are washed and rinsed to remove Contains detergent in MES buffer with chemical stabilizers.
unbound materials. Preservative: 0.1% ProClin 300

Second Reaction Alkaline phosphatase (ALP)-labeled anti-SARS- TUBE Squeeze Tube 20 pieces (2×10/bag)
CoV-2 monoclonal antibodies (mouse) TIP Applicator Tip 20 applicator tips (2×10 tips/bag)
specifically binds to SARS-CoV-2 antigen of the
immunocomplexes on the particles, and additional 3. Lumipulse G Substrate Solution: Liquid,
immunocomplexes are formed. 6 × 50 mL REF 231166 (For G600II)
6 × 100 mL REF 231197 (For G1200)
Washing The particles are washed and rinsed to remove Contains 0.2 mg/mL AMPPD as a substrate in diethanolamine buffer
unbound materials. with a chemical stabilizer. Preservative: sodium azide

-1-
 4. Lumipulse G Wash Solution: Concentrate, 2. PRECAUTIONS FOR HANDLING
1 × 1000 mL REF 231173 1) The products contain biological materials (See ¢ MATERIALS
Contains 342 mM sodium chloride in Tris buffer with a detergent. PROVIDED and ¢  MATERIALS REQUIRED BUT
Preservative: sodium azide PROVIDED SEPARATELY). No given tests can completely
guarantee that infected materials are absent. Accordingly, such
5. Lumipulse G Specimen Diluent 1: Liquid, materials should be considered potentially infectious. To avoid
4 × 80 mL REF 231180 (For G600II) risk of infection when using these products and human specimens,
4 × 300 mL REF 231203 (For G1200) wear disposable gloves and safety goggles to avoid direct contact
to them, do not perform pipetting by mouth and follow appropriate
Contains 0.15 M sodium chloride in Tris buffer with protein (bovine) biosafety practice.8)
and chemical stabilizers. Preservative: sodium azide 2) The following reagents contain sodium azide as a preservative.
Avoid contact with skin, eyes or mouth, and toxic gas formation
6. Sampling tips for LUMIPULSE SYSTEM (rack packed): with acids.
10 × 96 tips REF 302392 Wash Solution: 1.0% (w/v) (before dilution)
Ready to use for G600II. Substrate Solution: 0.05% (w/v)
Specimen Diluent 1: 0.1% (w/v)
7. Sampling tips for LUMIPULSE SYSTEM: Antibody - Coated Particle Solution: 0.095% (w/v)
12 × 96 tips REF 304945 Enzyme - Labeled Antibody Solution: 0.095% (w/v)
Ready to use for G1200. Sample Treatment Solution: 0.095% (w/v)
Reconstituting Solution: 0.05% (w/v)
8. Soda lime for LUMIPULSE SYSTEM: 3) The Substrate Solution is an alkaline solution (pH 10). Handle
6 × 2 tubes REF 234440 carefully to avoid contact with skin, eyes or mouth.
Ready to use. 4) In the event of accidental contact of any reagent with eyes or mouth,
perform first aid procedures such as rinsing thoroughly with water
9. Lumipulse G Dilution Cartridges: and seek medical attention if necessary.
3 × 14 Cartridges REF 230466
Ready to use. 3. PRECAUTIONS FOR USE
1) Read through this package insert, the safety data sheet (SDS)
* Lumipulse G SARS-CoV-2 Ag Calibrators set, Lumipulse SARS- and the LUMIPULSE G System Operation Manual. Follow the
CoV-2 Ag Sample Extraction Solution set for Nasopharynx swab, instructions. Incorrect use of the reagents, instruments, or other
Lumipulse G Substrate Solution, Lumipulse G Wash Solution and consumables may result in unreliable data or accident hazard.
Lumipulse G Specimen Diluent 1 are also referred to in this package 2) The SARS-CoV-2 Ag Cartridges (Antibody-Coated Particle
insert as ‘SARS-CoV-2 Ag Calibrators set’, ‘Sample Extraction Solution / Enzyme-Labeled Antibody Solution / Sample Treatment
Solution’, ‘Substrate Solution’, ‘Wash Solution’ and ‘Specimen Solution), SARS-CoV-2 Ag Calibrators set, Sample Extraction
Diluent 1’, respectively. Solution, Substrate Solution, Wash Solution and Specimen Diluent
1 are packed separately.
¢  MATERIALS REQUIRED BUT NOT PROVIDED 3) The SARS-CoV-2 Ag Cartridges can be stored on-board the
1. Purified water LUMIPULSE G System for a maximum of 30 days.
2. Control materials; refer to ¢  QUALITY CONTROL 4) Do not use expired reagents.
3. Micropipettes 5) To ensure measurement accuracy, always use freshly purified water.
4. Recommended sample cups; refer to the LUMIPULSE G System 6) Avoid using the reagents which may have been stored in an
Operation Manual and ¢ SPECIMEN COLLECTION AND improper way.
PREPARATION. Blood collection tubes without anticoagulant 7) Use new sampling tips and new sample cups as specified by the
can also be used as sample containers. Refer to the LUMIPULSE G LUMIPULSE G system. Refer to the LUMIPULSE G System
System Operation Manual. Operation Manual.
5. Recommended sterile swab: following swab is recommended for 8) Bring the SARS-CoV-2 Ag Calibrators set to room temperature (15-
use in the Lumipulse G SARS-CoV-2 Ag. 25 °C) before use. Add exactly 0.5 mL of Reconstituting Solution to
Nasopharyngeal swab: Sterile plain swab (CH swab AR, Catalog each lyophilized calibrator. Mix the calibrators by gentle inversion.
No. 170KS01. CE0124: Copan Italia S.p.A, Italy) Reconstituted SARS-CoV-2 Ag calibrators may be stored at 25
°C for up to 7 hours and 2-10 °C for up to 2 days when they are
¢  WARNINGS AND PRECAUTIONS stored in a proper way of avoiding contamination and evaporation.
For in vitro diagnostic use only. Do not freeze-thaw more than 2 times.
9) Do not transfer the reconstituted calibrators to another glass
1. SAFETY PRECAUTIONS container as this vial underwent special treatment.
Please refer to the safety data sheet (SDS) and product labeling for 10) Avoid contamination when handling calibrators set. Cap the vials
information on potentially hazardous components. The most recent immediately after use.
SDS version is available on the website www.fujirebio-europe.com. 11) Start the SARS-CoV-2 Ag assay immediately after sample setup
to avoid evaporation of the specimen or the SARS-CoV-2 Ag
Warning calibrators and controls.
H315: Causes skin irritation. 12) Avoid removing the Substrate Solution until replacement is
H319: Causes serious eye irritation. required. The Substrate Solution cannot be used if it is contaminated
H412: Harmful to aquatic life with long with ALP. Use new gloves when replacing the Substrate Solution.
lasting effects. 13) Replace the Soda lime on the LUMIPULSE G System according
P273: Avoid release to the environment. to the LUMIPULSE G System Operation Manual.
P280: Wear protective gloves/protective
clothing/eye protection/face protection. 4. PRECAUTIONS FOR WASTE
P305+P351 1) The reagents contain chemical components as previously described
+P338: IF IN EYES: Rinse cautiously with (For details see 2. PRECAUTIONS FOR HANDLING). Follow
water for several minutes. Remove any applicable regulations for disposal. If flushing down the drain,
contact lenses, if present and easy to use generous amount of water when discarding to prevent the
do. Continue rinsing. formation of explosive metal azides.
P332 + P313 If skin irritation occurs: Get medical 2) Handle any medical waste produced by this assay in compliance
advice/attention. with waste-related regulations in each country or region.
P337+P313: If eye irritation persists: Get medical 3) When any liquid such as specimen or assay waste is splashed,
advice/attention. wipe and disinfect the whole area with an appropriate disinfectant
P362 + P364: Take off contaminated clothing and such as sodium hypochlorite or ethanol, conform to the institute’s
wash it before reuse. biosafety requirements.
4) Avoid the use of acids to decontaminate the waste since sodium
azide with acids liberates toxic gases.

-2-
¢  STORAGE INSTRUCTIONS
Store the following reagents at 2-10 °C.
DO NOT FREEZE.
1) Lumipulse G SARS-CoV-2 Ag Immunoreaction Cartridges
2) Lumipulse G SARS-CoV-2 Ag Calibrators set
3) Lumipulse SARS-CoV-2 Ag Sample Extraction Solution set for
Nasopharynx swab
4) Lumipulse G Substrate Solution
5) Lumipulse G Wash Solution
6) Lumipulse G Specimen Diluent 1
When stored and handled properly, reagents remain stable until the
expiration date. Refer to the expiration date shown on the immediate
container labels.
¢ INSTRUMENT
The reagents are designed for a fully automated chemiluminescent
enzyme immunoassay (CLEIA) on the LUMIPULSE G System
(LUMIPULSE G1200 as leading instrument). Refer to the LUMIPULSE G
System Operation Manual for further information.
¢  REAGENT PREPARATION
1. Lumipulse G SARS-CoV-2 Ag Immunoreaction Cartridges
SARS-CoV-2 Ag Cartridges are filled with Antibody-Coated Particle
Solution, Enzyme-Labeled Antibody Solution, and Sample Treatment
Solution. Peel off the transparent film from the Immunoreaction
Cartridge case before installing the case for measurement.
2. Lumipulse G SARS-CoV-2 Ag Calibrators set
Bring the SARS-CoV-2 Ag Calibrators set to room temperature (15-25
°C). Add exactly 0.5 mL of Reconstituting Solution to each lyophilized
calibrator. Mix the calibrators by gentle inversion. Attach the bar code
label included in this kit on a sample tube (A sample cup cannot be
used because the size is not appropriate for the label) and dispense the
required amount (more than 200 μL) of calibrators into the sample
tube, taking into account the dead volume which is at least 250 μL
(total volume at least 450 μL) when using recommended sample tubes
with the LUMIPULSE G System. Refer to the LUMIPULSE G System
Operation Manual for recommended sample tubes, and the dead volume
of each type of sample tube.
3. Lumipulse SARS-CoV-2 Ag Sample Extraction Solution set for
Nasopharynx swab
Bring the Sample Extraction Solution to ambient temperature (20-
37°C) before use. Refer to the package insert of Lumipulse SARS-
CoV-2 Ag Sample Extraction Solution set for Nasopharynx swab for
general information.
4. Lumipulse G Substrate Solution
Use as is. Refer to the LUMIPULSE G System Operation Manual for
installing into the LUMIPULSE G System and the package insert of
Lumipulse G Substrate Solution for general information. Ensure the
substrate cap seal is properly installed to avoid air entering the system.
5. Lumipulse G Wash Solution
10 × concentrated solution. Prior to use, dilute 10 × with purified water
and mix thoroughly. The diluted Wash Solution shall be brought to room
temperature (15-25 °C). Refer to the LUMIPULSE G System Operation
Manual for loading onto the LUMIPULSE G System and the package
insert of Lumipulse G Wash Solution for general information.
6. Lumipulse G Specimen Diluent 1
Use as is, brought to room temperature (15-25 °C). Refer to the
LUMIPULSE G System Operation Manual for loading into the
LUMIPULSE G System and the package insert of Lumipulse G
Specimen Diluent 1 for general information.
¢  SPECIMEN COLLECTION AND PREPARATION
1. It is recommended to use fresh specimens.
2. The following specimen types may be used with the Lumipulse G
SARS-CoV-2 Ag: Refer to ¢  SAMPLE PREPARATION for each
specimen.
Specimen Types
nasopharyngeal swab fluid
saliva
virus preservation solution for nucleic acid testing
3. Samples may be stored at 15-25 °C for up to 24 hours, at 2-10 °C for
up to 7 days and at -20 °C for up to 30 days.
4. Do not perform a freeze/thaw cycle 4 or more times.
5. Specimens on-board the LUMIPULSE G System shall be tested within
3 hours.
-3-
6. Handle specimens carefully to avoid cross-contamination.
7. When specimens contain impurities, or are viscous, centrifuge at 2000g
for 5 minutes to obtain supernatant solution and assay the obtained
solution diluted with Specimen Diluent 1.
8. Specimens using sputum lysing enzymes or reducing agents may affect
the measurement values.
9. Dispense specimens to the sample containers. Sample cups and sample
tubes may be used as the sample containers. Refer to the LUMIPULSE
G System Operation Manual for the recommended sample cups and
sample tubes.
10. The Lumipulse G SARS-CoV-2 Ag uses 100 μL of specimen for each
assay. The dead volume is at least 100 μL and 250 μL when using
recommended sample cups and sample tubes with the LUMIPULSE
G System respectively. Therefore, the total sample volume required per
assay is over 200 μL for sample cups and 350 μL for sample tubes. The
size of the sample tubes for the LUMIPULSE G System is described
in the LUMIPULSE G System Operation Manual.
11. When shipped, package and label specimens in compliance with any
applicable regulations for the transport of clinical specimens and
infectious substances.
¢ SAMPLE PREPARATION for nasopharyngeal swab fluid
Following procedure is required for nasopharyngeal swab prior to start
assay.
1. Specimen Collection
1) Prepare a sterile swab.
2) Insert the sterile swab deeply into the nasopharyngeal cavity from
the nostril to reach adenoids and rub the nasopharyngeal turbinates
a few times to collect epidermis from the mucosa.
2. Specimen preparation
I) When using a squeeze tube
1) Bring the Sample Extraction Solution to ambient temperature (20-
37°C) before use.
2) Dispense 400 μL of the Sample Extraction Solution into the Squeeze
Tube using a micropipette.
3) Samples must be prepared immediately after specimen collection.
4) Insert the sterile swab deeply into the nasopharyngeal cavity from
the nostril to reach adenoids and rub the nasopharyngeal turbinates
a few times to collect epidermis from the mucosa.
5) Immediately immerse the cotton ball part of the swab in the Sample
Extraction Solution in the Squeeze Tube.
6) While holding the cotton ball part outside the Squeeze Tube with
your fingers, rotate the cotton swab about 10 times to extract the
sample from the cotton ball part.
7) Prepare the sample solution by slightly pressing the part above the
liquid surface below the neck of the Squeeze Tube and squeezing
out the liquid from the cotton ball part and take out the swab.
8) Firmly attach the Applicator Tip to the Squeeze Tube containing
the prepared sample solution.
9) Leave at the bench for about 5 minutes.
10) Add the entire amount of the sample solution from the Applicator
Tip (set into Squeeze Tube) into the sample cup, without bubbles
to prevent sampling errors.
II) When using test tubes, Spitz tubes, etc.
1) Bring the Sample Extraction Solution to ambient temperature (20-
37°C) before use.
2) Dispense 400 μL to 1mL of the Sample Extraction Solution into the
test tube using a micropipette.
3) Immediately immerse the cotton ball of the swab into the Sample
Extraction Solution in the container and suspend it.
4) After removing the swab, centrifuge at 2000g for 5 minutes. Take
the supernatant for measurement.
SAMPLE PREPARATION for saliva
¢
1. Collect about 1 mL of saliva in a sterile container.
2. Distribute the collected saliva into a commercially available sample
tube using a micropipette, etc., and add 1 to 3 fold the volume of PBS
or Specimen Diluent 1 to the saliva. The viscosity varies depending on
saliva, so change the volume accordingly.
3. Stir with a vortex mixer.
4. Centrifuge at 2000g for 5 minutes and dispense 250 μL or more of the
supernatant into the sample cup without bubbles.
¢  SAMPLE PREPARATION for virus preservation solution for
nucleic acid testing
Centrifuge at 2000g for 5 minutes. Take the supernatant for measurement.
To avoid risk of infection, please follow necessary biohazard practice
when handling samples. To be inactivated, please refer to reference etc.
if necessary.13)
*If the volume of the virus preservation solution is low or contains a
large amount of impurities and is highly viscous, centrifuge at 2000g for
5 minutes, take the supernatant, and dilute with Specimen Diluent 1 to
measure. Please set the dilution ratio in consideration of the viscosity of
the sample.
*There is a possibility making the detection sensitivity lower by the
specimen dilution process.
  ¢  ASSAY PROCEDURE
1. Refer to the LUMIPULSE G System Operation Manual and place
the specimens and reagents needed for measurement in the specified
locations. (The minimum specimen volume depends on the type of
container and the system. Refer to the Operation Manual of the system)
2. Enter the assay requests of SARS-CoV-2 Ag Calibrators and specimens.
3. Before starting the assay, confirm that the required amounts of SARS-
CoV-2 Ag Cartridges, Substrate Solution, diluted Wash Solution,
Specimen Diluent 1 and Sampling tips are set on the LUMIPULSE G
System.
4. Press the [Assay start] key to start the measurement. For automated
measurement method, refer to the “Reaction Protocol” of this package
insert.
5. If the SARS-CoV-2 antigen concentration in the specimen exceeds the
measurement range (>5000 pg/mL), dilute the specimen with Specimen
Diluent 1 and re-measure.
1) Automated dilution can be performed by making a dilution of
the specimen with the Lumipulse G Specimen Diluent 1 and
Lumipulse G Dilution Cartridges. It is confirmed that there is
no remarkable influence to the assay results when the sample is
diluted with 1:10, 1:100 or 1:200 dilution ratio on G600II, with
1:10, 1:100, 1:200 or 1:1000 dilution ratio on G1200. Refer to
the LUMIPULSE G System Operation Manual for additional
information of sample dilutions.
2) Manual dilution can be performed using Lumipulse G Specimen
Diluent 1 to the dilution ratio of up to 1:1000.
received for measurement of that analyte. Local regulations may require
more, or permit fewer controls than these recommendations. It is the
responsibility of the user to conduct Quality Control testing in accordance
with local regulations.9)
Fujirebio has quality control material available for use with the Lumipulse
G SARS-CoV-2 Ag assay on the LUMIPULSE G System.
Details of this material are as follows:
Lumipulse SARS-CoV-2 Ag Controls: REF 231876
Level 1 (6× ( 1.0 mL))
Level 2 (6× ( 1.0 mL))
RS Reconstituting Solution (2× 10 mL)
¢  LIMITATIONS OF THE PROCEDURE
1. For comprehensive diagnosis, consider all the various factors including
the results of other tests and clinical symptoms in addition to the values
obtained with this product.
2. Interference may be encountered with certain samples containing
nonspecific and/or unidentified reactive substances.
3. This reagent has been confirmed to be reactive to SARS-CoV.
4. Interfering Substances/Medications:
The addition of endogenous substances does not affect the measured
values. A list of tested compounds is shown in ¢ PERFORMANCE
CHARACTERISTICS. Other interfering substances may affect the
measurement results.
5. Precautions for interpretation
In case the measurement results are 1.00-10.00 pg/mL in nasopharyngeal
swab fluid, or 0.67 - 4.00 pg/mL in saliva, diagnose SARS-CoV-2
infection comprehensively, including the results of the nucleic acid
test method, if necessary.
¢  PERFORMANCE CHARACTERISTICS
1. Clinical data
1) Nasopharyngeal swab specimen using virus preservation solution
Using 325 Japanese clinical specimenss (Nasopharyngeal swab
specimen), we examined the correlation with the RT-PCR method.
For COVID-19 patients, a high correlation was observed between the
RNA copy number calculated from the RT-PCR Ct (Cycle Threshold)
value and the antigen concentration measured from this product.
㻝㻜㻜㻘㻜㻜㻜
Lumipulse G S A RS -CoV- 2 A g ( pg/mL)

¢ CALIBRATION 㻝㻜㻘㻜㻜㻜
1. Required Calibrators
Lumipulse G SARS-CoV-2 Ag Calibrators set 㻝㻘㻜㻜㻜
2. Calibration Procedure
Refer to ¢  REAGENT PREPARATION. For subsequent procedures,
㻝㻜㻜
follow the LUMIPULSE G System Operation Manual.
3. When to calibrate
Calibration is performed in the following cases: 㻝㻜

1) On the first assay of the Lumipulse G SARS-CoV-2 Ag. 㻝 㻚㻟㻠㻌

2) When the SARS-CoV-2 Ag Cartridges are replaced with a different 㻝
293 cases of negative concordance are
lot. distributed in this range but not shown.
3) When quality control results fall out of the range.
Ғ

㻜 Ғ
4) When 30 days have elapsed since the previous calibration. 㻜 㻝 㻡㻌 㻝㻜 㻝㻜㻜 㻝㻘㻜㻜㻜 㻝㻜㻘㻜㻜㻜 㻝㻜㻜㻘㻜㻜㻜 㻝㻘㻜㻜㻜㻘㻜㻜㻜

Update the calibration data whenever needed. Amount of RN A ( c opies/test)

4. The calibrator must be tested in duplicate.
5. Measurement Range Fig.1 Correlation with RT-PCR method
0.60 to 5000.00 pg/mL (Be careful that the LUMIPULSE G System
may indicate down to 0.01 pg/mL of SARS-CoV-2 antigen, which is The cut-off value of this product calculated by Youden's index by ROC
out of the measurement range.) analysis was 1.34 pg/mL. When the correlation was confirmed using
When SARS-CoV-2 antigen concentration in specimens exceeds this value, the sensitivity (positive concordance rate) was 91.7% (22/24
5000.00 pg/mL, dilute using Specimen Diluent 1 and then re-measure. cases), specificity (negative concordance rate) was 97.3% (293/301
cases), overall concordance rate was 96.9% (315/325 cases) (Table 1).
¢ RESULTS
The SARS-CoV-2 antigen concentration of a specimen is automatically Table 1. Comparison with RT-PCR method when the cutoff value is
calculated from the calibration curve, which is also automatically created 1.34 pg/mL
from calibration data. The result of the calculation is reported in pg/mL. RT-PCR method
Positive Negative Total
¢  QUALITY CONTROL
Good Laboratory Practice requires that controls are used to monitor Positive 22 8 30
the correctness of laboratory results. Fujirebio recommends that for This product Negative 2 293 295
LUMIPULSE G Series reagents, controls should be tested each time that Total 24 301 325
an assay is calibrated. In addition, we recommend that the laboratory
performs at least one, and preferably two or more levels of control on an 2) Saliva specimen
assay when samples are being run in a 24-hour period. Control testing Correlation to RT-PCR method was studied by using 1,924 specimens
of an assay is NOT recommended on days when no patient samples are (from Airport quarantine group and Close contact group) in Japan.

-4-
 A ROC analysis was implemented, and cutoff value calculated from by a commercially available purchased sample, there was a positive
results with Youden’s index was determined at 0.67 pg/mL. Results from correlation between the virus amount and the antigen amount
correlation study with the cutoff values showed as follows: sensitivity measured with this product, the coefficient of correlation was 0.9.
(positive concordance rate) 100.0% (4/4 cases), specificity (negative
concordance rate) 99.3% (1,746/1,759 cases), overall concordance 2) Saliva specimen
rate 99.3% (1,750/1,763 cases) on Airport quarantine group (see Table As a result of investigating the correlation with the RT-PCR
2), and sensitivity (positive concordance rate) 70.5% (31/44 cases), method by adding a commercially available purchased sample
specificity (negative concordance rate) 100.0% (117/117 cases), overall to the SARS-CoV-2 antigen-negative saliva sample, there was a
concordance rate 91.9% (148/161 cases) on Close contact group (see positive correlation between the virus amount and the antigen amount
Table 3). For 13 discordant samples on Close contact group for RT-PCR measured with this product, the coefficient of correlation was 0.8.
method, the Ct value for RT-PCR was 33-35 for 4 cases and 35 or over
for 9 cases. ¢ BIBLIOGRAPHY
1) Wu F, et al. A new coronavirus associated with human respiratory
Table 2. Comparison with RT-PCR method when the cutoff value is disease in China Nature, 579: 265-269, 2020.
0.67 pg/mL 2) Coronaviridae Study Group of the International Committee on
Taxonomy of Viruses. The species Severe acute respiratory syndrome-
Airport quarantine group related coronavirus: classifying 2019-nCoV and naming it SARS-
RT-PCR method CoV-2. Nat Microbiol, 5: 536-544, 2020.
3) WHO website ”Rolling updates on coronavirus disease(COVID-19)”
Positive Negative Total
(https://www.who.int/emergencies/diseases/novel-coronavirus-2019/
Positive 4 13 17 events-as-they-happen) Medical Research and Development.
This product Negative 0 1746 1746 4) WHO Director-General's opening remarks at the media briefing on
Total 4 1759 1763 COVID-19 - 11 March 2020
(https://www.who.int/dg/speeches/detail/who-director-general-s-
Close contact group opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020)
RT-PCR method 5) Di Gennaro F, et al. Coronavirus Diseases (COVID-19) Current Status
and Future Perspectives: A Narrative Review. Int J Environ Res Public
Positive Negative Total
Health, 17: 2690, 2020.
Positive 31 0 31 6) Iwasaki S, et al. Comparison of SARS-CoV-2 detection in
This product Negative 13 117 130 nasopharyngeal swab and saliva [published online ahead of print,
Total 44 117 161 2020 Jun 4]. J Infect. 2020;S0163-4453(20)30349-2. doi:10.1016/j.
jinf.2020.05.071.
7) Nishizono I, et al. Rapid and sensitive chemiluminescent enzyme
2. Sensitivity immunoassay for measuring tumor markers. Clin Chem, 37: 1639-
1) Analytical sensitivity 1644, 1991.
The limit of detection (LoD) for Lumipulse G SARS-CoV-2 Ag 8) World Health Organization. Laboratory Biosafety Manual – Third
was determined to be 0.19 pg/mL when analyzed in accordance to Edition. Geneva: World Health Organization; 2004.
the guidelines in the CLSI document EP17-A2.10) 9) Clinical and Laboratory Standards Institute. Statistical Quality Control
for Quantitative Measurement Procedures: Principles and Definitions;
2) Functional sensitivity Approved Guideline – 4th Edition. CLSI guideline C24.
The limit of quantification (LoQ) for Lumipulse G SARS-CoV-2 Ag 10) Clinical and Laboratory Standards Institute. Evaluation of Detection
were determined to be 0.60 pg/mL when analyzed in accordance to Capability for Clinical Laboratory Measurement Procedures; Approved
the guidelines in the CLSI document EP17-A2.10) Guideline – Second Edition. CLSI document EP17-A2.
11) Clinical and Laboratory Standards Institute. Interference Testing in
3. Interference Clinical Chemistry. Third Edition. CLSI guideline EP07-A3.
Lumipulse G SARS-CoV-2 Ag demonstrated interference for each 12) Clinical and Laboratory Standards Institute. Evaluation of the Linearity
compound shown in the tables below, in a study consistent with the of Quantitative Measurement Procedures: A Statistical Approach;
guidelines in the CLSI document EP07-A3.11) Approved Guideline – CLSI document EP06-A.
Endogenous Interferences 13) Darnell ME, et al. Inactivation of the coronavirus that induces severe
acute respiratory syndrome, SARS-CoV. J Virol Methods, 121: 85-91,
Whole blood 0.5%
2004.
Hemoglobin 115mg/dL
Specimens using sputum lysing enzymes and reducing agents may
affect the measured values.

4. Cross-reactivity
Lumipulse G SARS-CoV-2 Ag did not show cross-reactivity with
inactivated Influenza viruses (Influenza virus H1N1, Influenza virus
H3N2, Influenza virus B) and in-house recombinant human coronavirus
antigens (MERS-CoV, HCoV-229E, HCoV-OC43, HCoV-NL63,
HCoV-HKU1), but reacted with in-house recombinant human
coronavirus antigen SARS-CoV. However, we have not examined the
cross reactivity with the native antigen.

5. Linearity
The linearity with Lumipulse G SARS-CoV-2 Ag on the LUMIPULSE
G1200 was evaluated according to an internal protocol based on CLSI
document EP06-A.12) The linearity was shown between 0.36pg/mL to
6056.64 pg/mL.

6. Method Comparison
The method comparison was performed on LUMIPULSE G600II.

1) Nasopharyngeal swab specimen using virus preservation solution

As a result of investigating the correlation with the RT-PCR method

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¢ CONTACT
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Fujirebio Europe N.V.
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FAX: +39-06 965 28 765 FAX: +34-93 270 53 02
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Fujirebio Europe N.V.

TEL: +32-9 329 13 29
FAX: +32-9 329 19 11
customer.support@fujirebio-europe.com

Lumipulse is a registered trademark of Fujirebio Inc. in Japan and in other

countries.

¢  GLOSSARY OF SYMBOLS
CE Marking (European directive 98/79/EC on in vitro diagnostic medical
devices)

Authorised Representative in the European Community

In Vitro Diagnostic Medical

Batch Code
Device

Contains Sufficient for

Consult Instructions for Use
<n> Tests

REF Catalogue Number Use by

Keep Away from Sunlight Do Not Reuse

Manufacturer Temperature Limitation

Contents of the Kit Fragile, handle with care

CAL SET Calibrators set IRC Immunoreaction Cartridges

CAL Calibrators CAL 1 Calibrator (1-4)

RS Reconstituting Solution Level (1-2)

After reconstitution SES Sample Extraction Solution

Warning TUBE Squeeze Tube

Warning TIP Applicator Tip

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