instructions for use3 sars-cov-2 fluorescent pcr instructions for use doc. rev. 1.0 intended use...
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SARS-CoV-2 Fluorescent PCR Kit
For Research Use Only (RUO)
Instructions for Use
Catalog Number
BUSGN7101109 32 tests
BUSGN7102109 64 tests
BUSGN7103109 96 tests
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Content
Intended Use .......................................................................................................... 3
Product Description ............................................................................................... 3
Summary and Explanation .................................................................................... 3
Contents and Storage ............................................................................................. 4
Equipment and Consumables Required ................................................................ 5
Warnings and Precautions ..................................................................................... 6
Workflow ............................................................................................................... 7
Specimen Collection and Preparation ................................................................... 8
Extract RNA with Nucleic Acid Extraction Kit .................................................... 9
Perform RT-PCR ................................................................................................. 11
Analyze the Data ................................................................................................. 12
Results Interpretation .......................................................................................... 13
Assay Limitations ................................................................................................ 14
Conditions of Authorization for the Laboratory ................................................. 14
Performance Characteristics ................................................................................ 16
Limit of Detection (LoD) ............................................................................ 16
Inclusivity .................................................................................................... 16
Cross-reactivity ........................................................................................... 16
Interference Substances Studies .................................................................. 19
Clinical Evaluation ...................................................................................... 19
Disposal ............................................................................................................... 20
Manufacturer and Distributors ............................................................................ 21
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Intended Use
SARS-CoV-2 Fluorescent PCR Kit is a real-time RT-PCR test intended for the qualitative
detection of nucleic acid from the SARS-CoV-2 in oropharyngeal swab and sputum specimens
from individuals with signs and symptoms of infection who meet CDC criteria for SARS-CoV-
2 testing.
Testing is limited to qualified laboratories designated by CDC and, in the United States,
certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.
§ 263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories
The SARS-CoV-2 RNA is generally detectable in oropharyngeal swabs and sputa during the
acute phase of infection. Positive results are indicative of presence of SARS-CoV-2 RNA,
clinical correlation with patient history, clinical observations and other diagnostic information
is needed to determine patient infection status. Laboratories within the United States and its
territories are required to report all positive results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis
for patient management decisions. Negative results must be combined with clinical
observations, patient history, and epidemiological information.
The SARS-CoV-2 Fluorescent PCR Kit is intended for use by experimental operators who have
received professional training in genetic amplification or molecular biological method testing,
and have relevant experimental operation qualifications. The SARS-CoV-2 Fluorescent PCR
Kit is only for use under the Food and Drug Administration’s Emergency Use Authorization.
Product Description
The SARS-CoV-2 Fluorescent PCR Kit contains 3 primer/probe sets which designed to detect
RNA from the SARS-CoV-2 in oropharyngeal swabs and sputa from patients with signs and
symptoms of infection who are suspected of COVID-19, the 3 primer/probe sets target ORF1ab,
N and E gene, respectively.
Summary and Explanation
A cluster of unknown pneumonia cases was reported in Wuhan City, Hubei Province, People’s
Republic of China in late December 2019, which later became a pandemic outbreak known as
coronavirus disease 2019 (COVID-19). Severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2), previously known by the provisional name 2019-nCoV, is the cause of COVID-
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19. SARS-CoV-2 is a positive-sense single-stranded RNA virus, belonging to genus
Betacoronavirus. Patients infected with the SARS-CoV-2 may be asymptomatic or develop
symptoms such as fever, cough, fatigue, sputum production, shortness of breath, or muscle pain.
Further development can lead to severe pneumonia, acute respiratory distress syndrome, sepsis,
septic shock, and death.
The SARS-CoV-2 Fluorescent PCR Kit is a molecular in vitro diagnostic test that aids in the
detection and diagnosis SARS-CoV-2 and is based on widely used nucleic acid amplification
technology. The product contains oligonucleotide primers and dual-labeled hydrolysis probes
and control material used in real time RT-PCR for the in vitro qualitative detection of SARS-
CoV-2 RNA in respiratory specimens.
Contents and Storage
Table 1 SARS-CoV-2 Fluorescent PCR Kit
Component Storage 32 Tests 64 Tests 96 Tests
qRT-PCR Reaction Mix -30℃ to -10℃ 544 μL×1 1088 μL×1 816 μL×2
qRT-PCR Enzyme Mix -30℃ to -10℃ 96 μL×1 192 μL×1 288 μL×1
Negative Control -30℃ to -10℃ 450 μL×1 900 μL×1 1350 μL×1
Positive Control -30℃ to -10℃ 450 μL×1 900 μL×1 1350 μL×1
Internal Control -30℃ to -10℃ 64 μL×1 128 μL×1 192 μL×1
Table 2 Nucleic Acid Extraction Kit, Manual Version (Cat. No. GN7102903, 48 tests)
Component Ingredient Storage 48 Tests
Extraction reagent ① Proteinase K 2°C to 8°C 500 μL×1
Extraction reagent ② Lysis Buffer 2°C to 8°C 31 mL×1
Extraction reagent ③ Magnetic nanoparticles 2°C to 8°C 250 μL×1
Extraction reagent ④ Wash Buffer 1 2°C to 8°C 41 mL×1
Extraction reagent ⑤ Wash Buffer 2 2°C to 8°C 36 mL×1
Extraction reagent ⑥ Mineral oil 2°C to 8°C 5 mL×1
Extraction reagent ⑦ Elution Buffer 2°C to 8°C 1.8 mL×1
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Table 3 Nucleic Acid Extraction Kit, Fast Version (Cat. No. GN7101909, 32 tests)
Component Ingredient Storage 32 Tests
Extraction reagent
Tris Hydrochloride, Triton X-
100, Sodium hydroxide,
Carrier RNA, DEPC treated
water
-30℃ to -10℃ 1.8 mL×1
Equipment and Consumables Required
Vortex mixer
Microcentrifuge
DynaMag-2 Magnet (Invitrogen, Cat. No. 12321D)
Micropipettes (2 or 10 μL, 200 μL and 1000 μL)
Aerosol barrier pipette tips
Racks for 1.5 mL microcentrifuge tubes
Disposable powder-free gloves and surgical gowns
1.5 mL microcentrifuge tubes (DNase/RNase free)
0.2 mL PCR reaction plates, or 0.2 mL Flat PCR tube 8-cap strips
QIAamp Viral RNA Mini Kit (QIAGEN)
7500 Real-Time PCR Systems with v2.3 software (Applied Biosystems)
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Warnings and Precautions
For Research Use Only.
Follow standard precautions. All patient specimens and positive controls should be considered
potentially infectious and handled accordingly.
Do not eat, drink, smoke, apply cosmetics or handle contact lenses in areas where reagents and
human specimens are handled.
Modifications to assay reagents, assay protocol, or instrumentation are not permitted, and are
in violation of the product Emergency Use Authorization.
Handle all specimens as if infectious using safe laboratory procedures. Refer to Interim
Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with
SARS-CoV-2 https://www.cdc.gov/coronavirus/2019-nCoV/lab-biosafety-guidelines.html.
Specimen processing should be performed in accordance with national biological safety
regulations.
Dispose of waste in compliance with the local, state, and federal regulations.
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Workflow
The workflow begins with nucleic acids extraction from oropharyngeal swabs which arrive in
the testing site in sample transport/preservation media and sputa. Nucleic acid isolated and
purified using Nucleic Acid Extraction Kit (Maccura), Fast version and Manual version are
provided respectively. For Fast version (only compatible with swab sample), inputting 200μL
sample, 50μL nucleic acid is then eluted, for Manual version, inputting 200μL sample, nucleic
acid is eluted with the volume of 35μL. QIAamp Viral RNA Mini Kit (QIAGEN) is the
alternative for RNA Isolation, 140μL sample input, elution volume is recommended as 80μL.
The purified nucleic acid is reverse transcribed and amplified in One-Step using qRT-PCR
Reaction Mix and qRT-PCR Enzyme Mix, 20μL RNA template is added in qRT-PCR mix, and
the RT-PCR is performed in Applied Biosystems™ 7500 Real-Time PCR instrument. In the
process, the probe anneals to a specific target sequence located between the forward and reverse
primers. During the extension phase of the PCR cycle, the 5’ nuclease activity of Taq
polymerase degrades the probe, causing the reporter dye to separate from the quencher dye,
generating a fluorescent signal. With each cycle, additional reporter dye molecules are cleaved
from their respective probes, increasing the fluorescence intensity. Fluorescence intensity is
monitored at each PCR cycle by Applied Biosystems™ 7500 Real-Time PCR Systems.
Extract RNA from OP or sputum specimens using Nucleic Acid Extraction Kit
Perform RT-PCR using the Applied Biosystems™ 7500 Real-Time PCR Instrument
Analyze data using the Applied Biosystems™ 7500 Real-Time PCR Systems with
v2.3 software
Review results interpretation for patient samples
Prepare qRT-PCR Mix (17 μL qRT-PCR Reaction Mix + 3 μL qRT-PCR Enzyme Mix)
Add sample and control (20 μL RNA template)
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Specimen Collection and Preparation
For oropharyngeal swabs
Put the collected oropharyngeal swabs into the disposable virus sampling tube containing virus
preservation solution, discard the tail and tighten lid.
For sputa
Sputum specimen should be liquefied with phosphate buffer which contains 1g/L proteinase K,
then tighten lid and seal with sealing film. The sputum specimen should be sent for test within
30 minutes as far as possible.
Before the test of sputum specimen, incubate the specimen at 55℃ for 15 minutes to inactivate
virus. Add proteinase K after incubation if sputum collection cup not containing proteinase K,
then repeat the incubation step.
General requirements for specimen transport and inactivation
It is recommended to test the specimen as soon as possible. Specimens may be stored for up to
24 hours at 2°C~8°C, otherwise shall be stored at -70°C for longer storage, however, multiple
freeze-thaw cycles of specimens should be avoided.
For inactivating virus, preheat a constant temperature water bath to 56℃ in advance, spray the
sealed package containing the specimen with 75% ethanol in a biosafety cabinet. After wiping
the sealed package with absorbent paper, place the specimen in the water bath for 30min. Cover
the collection tube with heavy objects to prevent it from floating. Gently blend the specimen
per 10min.
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Extract RNA with Nucleic Acid Extraction Kit
Before you begin
Take out and equilibrate all extraction reagent components and Internal Control (from SARS-
CoV-2 Fluorescent PCR Kit) at ambient temperature, vortex and transfer to the sample area.
Manual Version (Cat. No. GN7102903)
Sample preparation
This step requires laboratory’s own magnetic separator (DynaMag-2 Magnet (Invitrogen, Cat.
No. 12321D) is recommended).
1. Mark 1.5mL or 2.0mL centrifuge tube and add 10μL of Extraction reagent ① to each tube.
2. Add 200~300μL of specimen to each tube, close the lid, vortex for 5 seconds, and spin down
briefly.
3. Prepare Magnetic beads Mix:
Name Reagent Volume/test Number of tests
Magnetic beads Mix
Extraction reagent ③ 5μL N=n+2
Internal Control 2μL
Note: The number of tests is N = n + 2, where n is the number of samples to be tested, and 2
indicate Negative Control and Positive Control. Based on laboratory conditions, due
consideration shall be given to the losses in the mixture dispensing process.
4. Add 600μL of Extraction reagent ②, 7μL of Magnetic beads Mix to each tube, close the lid,
vortex for 10 seconds, and incubate for 10 minutes at ambient temperature.
5. Spin down briefly and place the tube on the magnetic separator, hold for 3 minutes, then
slowly pipette out and discard the supernatant (avoid touching the brown sediment attached to
the wall of the tube).
6. Add 800µL of Extraction reagent ④ to each tube, close the lid, vortex for 5 seconds, spin
down briefly and place the tube on the magnetic separator, hold for 3 minutes, then slowly
pipette out and discard the supernatant (avoid touching the brown sediments attached to the
wall of the tube).
7. Add 700µL of Extraction reagent ⑤ and 100µL of Extraction reagent ⑥ to each tube,
close the lid, vortex for 5 seconds, spin down briefly and place the tube on the magnetic
separator again.
8. After holding for 3 minutes, two layers of supernatant are obviously visible, insert the pipette
tip to the bottom, slowly pipette out and discard the bottom layer, vortex for 30 seconds and
place the tube on the magnetic separator again.
9. After holding for 3 minutes, pipette out and discard residual supernatant.
10. Add 35µL of Extraction reagent ⑦ to each tube, vortex to resuspend brown sediments
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completely in the solution, then incubate at 60℃ for 10 minutes.
11. Spin down briefly, place the tube on the magnetic separator and hold for 3 minutes, the
supernatant can be used for subsequent tests, or transferred to a clean Eppendorf tube and stored
at -20℃ or below.
Fast Version (Cat. No. GN7101909)
Sample preparation (only compatible with oropharyngeal swab)
1. Transfer 200μL of specimen, add 2μL Internal Control to 1.5mL centrifuge tube, centrifuge
at ambient temperature for 10min at 13,000 xg.
2. After centrifugation, remove supernatant by pipetting. (avoid touching the sediment if there
is any).
3. Add 50μL of Extraction Reagent, vortex for 10 seconds, and incubate for 10 minutes at
ambient temperature for later use.
Note: If nucleic acid is extracted with QIAamp Viral RNA Mini Kit (QIAGEN), remember to
add 2μL Internal Control with per sample. Recommended volume of extraction and elution is
as follows:
Extraction reagent Volume of sample Volume of elution buffer
QIAamp Viral RNA Mini Kit 140μL 80μL
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Perform RT-PCR
Reagent preparation (in reagent preparation area)
1. Take out and equilibrate all reagent components at ambient temperature, vortex briefly.
2. Prepare qRT-PCR Mix according to the following table:
Name Reagent Volume/test Number of tests
qRT-PCR Mix qRT-PCR Reaction Mix 17μL
N=n+2 qRT-PCR Enzyme Mix 3μL
Note: The number of tests is N = n + 2, where n is the number of samples to be tested, and 2
indicate negative control and positive control. Based on laboratory conditions, due
consideration shall be given to the losses in the mixture dispensing process.
3. Aliquot qRT-PCR Mix (20μL/test) into PCR reaction tube/plate.
Sample preparation (in the sample preparation area)
1. Add 20μL RNA template (nucleic acid extracted from Negative Control, Positive Control
and specimen) to the PCR reaction tube/plate containing qRT-PCR Mix, Final volume should
be 40μL/test.
2. Close the lid or seal the plate immediately to avoid contamination. Spin down briefly and get
ready to perform PCR reaction.
PCR amplification (in the thermal-cycling area)
1. Set up the Applied Biosystems™ 7500 Real-Time PCR Instrument.
Reaction volume: 40μL.
Passive reference: None
Assay is as follows:
IMPORTANT!
• The experiment workflow is recommended to be carried out in segmented PCR
laboratories.
• To prevent contamination, prepare reagents in a PCR workstation or equivalent
amplicon-free area, always use aerosol barrier pipette tips processing samples and
positive controls, and do not reuse the pipette.
• Run the plate / strip within two hours of preparation.
• Include one Positive Control and one Negative Control per run, at least.
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Fluorescence channel setting:
Reporter Dye FAM VIC / HEX ROX CY5
Quencher None None None None
Detector ORF1ab Internal Control E gene N gene
Set up the plate layout by assigning a unique sample name to each well.
Set and confirm the thermal-cycling protocol:
Step Temperature Time Cycles
1 Reverse transcription 55℃ 15min 1
2 Taq polymerase activation, pre-denaturing 95℃ 2min 1
3 Denaturation 95℃ 15sec
40 Annealing, extension, fluorescence acquisition 58℃ 35sec
4 Instrument cooling 40℃ 10sec 1
2. Save file, start run.
Analyze the Data
1. Set the Ct Threshold
Please save the result after run is completed at first. Threshold level, Start value and End value
of baseline of different channel could be manually adjusted as follows: Start value sets to 3~15,
end value sets to 5~20. Threshold level should be adjusted according to fluorescence
background and Negative Control (NC): higher than fluorescence background and NC. FAM,
ROX, CY5 amplification curve of NC should be horizontal or lower than Threshold level. Click
“Analyze” and view the results on the Report screen.
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2. Quality control
Any experiment should meet the following requirements, otherwise the sample results are
invalid and should be retested.
Control Name FAM VIC / HEX ROX CY5
Positive Control ≤32 ≤38 ≤32 ≤32
Negative Control >38 or no Ct value ≤38 >37 or no Ct value >38 or no Ct value
3. Export data
Select the well containing samples and controls, export file (XLSX) to a folder.
Results Interpretation
Interpretation of Ct value of the target gene
Result of judgement Negative (-) Positive (+)
FAM channel (ORF1ab) >38 or no Ct value ≤38
ROX channel(E gene) >37 or no Ct value ≤37
Cy5 channel(N gene) >38 or no Ct value ≤38
HEX or VIC channel(Internal Control) ≤38 /
Based on the above test results, the sample interpretation is as follows:
Test result Result interpretation
ORF1ab, N gene and E gene are all (+)
SARS-CoV-2 positive ORF1ab (+) and N gene (+)
ORF1ab (+) and E gene (+)
Only ORF1ab gene (+) Repeat the test (on the same sample). If it is still (+), it will be
interpreted as SARS-CoV-2 positive
Only ORF1ab gene (-) Repeat the test. If ORF1ab, and N gene and/or E gene are (+),
interpret the result as SARS-CoV-2 positive; Otherwise
interpret the result as suspect who need to be retested the other
time.
ORF1ab (-) and N gene (+)
ORF1ab (-) and E gene (+)
ORF1ab, N gene and E gene are all (-) SARS-CoV-2 negative
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Assay Limitations
• The test result of this product is positive, which can indicate the presence of SARS-CoV-2
in the tested samples. The clinical diagnosis and treatment of patients should be considered
in combination with other symptoms/signs, medical history, other laboratory tests and
treatment responses.
• The results of sample testing are related to the process of sample collection, transfer,
storage and processing, and any mistakes may lead to inaccurate results. If cross-
contamination is not properly controlled during sample processing, false positive results
may occur.
• The test is limited to the specified extraction reagents, specimen types, and applicable
instruments. Other unverified situations require laboratory verification before use.
• During the design of this product, relatively conservative fragments of viral nucleic acids
were selected for amplification and detection, but the virus gene is possible to mutate.
Although the mutation rate in the conservative region which selected for amplification
detection is very small, but the possibility cannot be completely avoided theoretically.
• This product cannot be used for the differential diagnosis of SARS.
• Test results shall be determined according to the “result interpretation”.
Conditions of Authorization for the Laboratory
The SARS-CoV-2 Fluorescent PCR Kit Letter of Authorization, along with the authorized Fact
Sheet for Healthcare Providers, the authorized Fact Sheet for Patients and authorized labeling
are available on the FDA website:
Use of the SARS-CoV-2 Fluorescent PCR Kit must follow the procedures outlined in these
manufacturer’s Instructions for Use and the conditions of authorization outlined in the Letter of
Authorization. Deviations from the procedures outlined are not permitted under the Emergency
Use Authorization (EUA). To assist clinical laboratories running the SARS-CoV-2 Fluorescent
PCR Kit, the relevant Conditions of Authorization are listed verbatim below, and are required
to be met by laboratories performing the EUA test.
Authorized laboratories1 will include with reports of the results of the SARS-CoV-2
Fluorescent PCR Kit, all authorized Fact Sheets. Under exigent circumstances, other
appropriate methods for disseminating these Fact Sheets may be used, which may include mass
media.
Authorized laboratories will perform the SARS-CoV-2 Fluorescent PCR Kit as outlined in the
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SARS-CoV-2 Fluorescent PCR Kit Instructions for Use. Deviations from the authorized
procedures, including the authorized RT-PCR instruments, authorized extraction methods,
authorized clinical specimen types, authorized control materials, authorized other ancillary
reagents and authorized materials required to perform the SARS-CoV-2 Fluorescent PCR Kit
are not permitted.
Authorized laboratories will have a process in place for reporting test results to healthcare
providers and relevant public health authorities, as appropriate.
Authorized laboratories will collect information on the performance of the test and report to
DMD/OHT7-OIR/OPEQ/CDRH (via email: [email protected]) and CDC
([email protected]) any suspected occurrence of false positive or false negative results and
significant deviations from the established performance characteristics of the test of which they
become aware.
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Performance Characteristics
Limit of Detection (LoD)
LoD studies determine the lowest detectable concentration of SARS-CoV-2 at which
approximately 95% of 20 replicates test positive. The LoD was determined by limiting dilution
studies using contrived samples which prepared by oropharyngeal swab and sputum matrix,
respectively, and spiked with viral genomic RNA at several concentrations and processed
through the SARS-CoV-2 Fluorescent PCR Kit workflow.
Extraction Reagent LoD
Oropharyngeal swab Sputum
Nucleic Acid Extraction Kit (Manual) 1000 copies/mL 1000 copies/mL
Nucleic Acid Extraction Kit (Fast) 1000 copies/mL Not compatible
QIAamp Viral RNA mini Kit 1000 copies/mL 1000 copies/mL
Inclusivity
In silico analysis including NCBI Nucleotide BLAST and MegAlign analysis, typical SARS-
CoV-2 isolate sequences (published on GISAID and NCBI) from different country were chosen
to analyze. Results show ORF1ab primer/probe set is the most specific primer/probe set among
the three, targeting all SARS-CoV-2 strains, but not any other human coronavirus, while N gene
and E gene primer/probe sets not only targeting SARS-CoV-2, but also targeting SARS-CoV
or bat coronavirus.
Thus, ORF1ab + E + N was used in combination to interpret result, and ORF1ab result serves
as the most important and final determination to indicate the presence of SARS-CoV-2 RNA.
N gene and E gene results serve as the measure to prevent false negative result. Thus in silico
inclusivity results were acceptable for this product.
Cross-reactivity
In silico analysis of the following microorganisms:
Microorganism
Alignment between primer/probe and sequence
ORF1ab E gene N gene
Primer Set Probe Primer Set Probe Primer Set Probe
Human coronavirus 229E No PCR product
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Microorganism
Alignment between primer/probe and sequence
ORF1ab E gene N gene
Primer Set Probe Primer Set Probe Primer Set Probe
Human coronavirus HKU1 No PCR product
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Microorganism
Alignment between primer/probe and sequence
ORF1ab E gene N gene
Primer Set Probe Primer Set Probe Primer Set Probe
Respiratory syncytial virus No PCR product
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The In silico analysis including Primer-BLAST and probe blastn. Primer-BLAST results
indicate SARS-CoV has potential amplification of ORF1ab, E gene and N gene, while blastn
results indicate the probe of E gene and N gene have 100% identity with SARS-CoV, the probe
of ORF1ab has 88% identity. Given the low prevalence of SARS-CoV, the in silico results are
clinically irrelevant. Other selected organism isolates show no PCR product of ORF1ab, E gene
and N gene, probe blastn results show alignments have
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that the comparator assay and the evaluated assay are highly consistent.
In between clinical diagnosis and the evaluated assay, a total number of 537 samples were
statistically analyzed, in which 231 samples were clinically diagnosed as positive for SARS-
CoV-2, while 306 samples were excluded for SARS-CoV-2. As a result, 230 samples are
consistently positive between clinical diagnosis and the evaluated assay, and the positive
coincidence rate is 99.57% [95%CI:97.59%~99.92%], while 306 samples are consistently
negative, and the negative coincidence rate is 100%[95%CI:98.76%~100%]. Total coincidence
rate is 99.81% [95%CI:98.95%~99.97%]. Kappa coefficients is 0.996, which is higher than
0.8, indicating that clinical diagnosis and the evaluated assay are highly consistent.
To summarize, the evaluated assay (Maccura) is equivalent to similar NMPA approved
comparator assays as well as clinical diagnosis. The analytical sensitivity and analytical
specificity of the evaluated assay is sufficient to meet clinical needs.
Disposal
Dispose of hazardous or biologically contaminated materials according to the practices of your
institution.
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Manufacturer and Distributors
Manufacturer information
Manufacturer Name: Maccura Biotechnology Co., Ltd.
Address: 16#, Baichuan Road, Hi-tech Zone, 611731 Chengdu, PEOPLE'S REPUBLIC OF CHINA
Post-sale Service Unit: Maccura Biotechnology Co., Ltd.
Tel: +86 28 8782 6777
Fax: +86 28 8782 5783
E-mail: [email protected]
Production Address: 16#, Baichuan Road, Hi-tech Zone, 611731 Chengdu, PEOPLE'S REPUBLIC OF CHINA
Distributor information
Maccura Biotechnology (USA) LLC
11300 Rockville Pike, Suite 715, Rockville, MD 20852
Tel: 240-669-9948
Fax:240-833-3956
Symbols for use in the labeling
Symbols Definition
PROTECT FROM SUNLIGHT
STORAGE TEMPERATURE LIMITATION
IN VITRO DIAGNOSTIC USE
UPWARD
DISPOSE IN TRASH AFTER USE
RECYCLABLE MATERIAL
CONSULT INSTRUCTIONS FOR USE
BATCH CODE
CATALOGUE NUMBER
USE BY
DATE OF MANUFACTURE
MANUFACTURER
SUFFICIENT FOR TESTS