SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)

SARS-CoV-2 Antigen Fast Check Package
(Colloidal Gold)

【PRODUCT NAME】

SARS-CoV-2 Antigen Fast Check Package (Colloidal Gold)

【PACKAGE AND SPECIFICATION】

20 Exams/field (1Test/bag ×20 Baggage) ,40 Exams/field (1Test/bag ×40 Baggage)

【INTENDED USE】

For in vitro qualitative detection of SARS-CoV-2 nucleocapsid
antigen in nasal (NS) swab specimens straight from
people who’re suspected of COVID-19 by their healthcare supplier throughout the first 5 days after onset of signs. This take a look at is barely offered to be used by scientific
laboratories or to healthcare employees for point-of-care testing, not for at-home testing. Extreme acute respiratory syndrome coronavirus 2
(SARS-CoV-2, or 2019-nCoV) is an enveloped
non-segmented positive-sense RNA virus. It’s the reason for coronavirus illness (COVID-19), which is contagious in
people. SARS-CoV-2 has a number of structural proteins
together with spike (S), envelope (E), membrane (M), and
nucleocapsid (N). The antigen is mostly detectable in higher respiratory
samples through the acute section of an infection. Constructive outcomes
point out the presence of viral antigens, however the scientific correlation with affected person historical past and different diagnostic
info is critical to find out an infection standing.

ace2 receptor
ace2 receptor

Constructive outcomes don’t rule out a bacterial an infection or co-infection with
different viruses. The agent detected might not be the particular reason for illness. Destructive outcomes must be handled as presumptive, which do
not rule out SARS-CoV-2 an infection and shouldn’t be used as
the only real foundation for therapy or affected person administration choices, together with an infection management choices. Destructive outcomes ought to
be thought of within the context of a affected person’s latest exposures, historical past, and the presence of scientific indicators and signs in step with COVID-19, and confirmed with a molecular assay, if essential, for affected person administration. For in vitro diagnostic use solely. For skilled use solely

【TEST PRINCIPLE】
JOYSBIO Biotechnology’s SARS-CoV-2 Antigen Fast Check Package makes use of an immunocapture methodology, it’s designed to detect the presence or absence of SARS-CoV-2 nucleocapsid proteins in
respiratory samples from sufferers with indicators and signs of
an infection who’re suspected of COVID-19. Key elements: the anti-nucleocapsid protein antibody and
rooster IgY labeled by colloidal gold, the nitrocellulose membrane coated with anti-nucleocapsid protein antibody, and
goat anti-chicken IgY antibody. When specimens are processed and added to the take a look at machine, SARS-CoV-2 antigens current within the specimen bind to
antibodies conjugated to colloidal gold within the take a look at strip. The
antigen-conjugate complexes migrate throughout the take a look at strip to
the response space and are captured by a line of antibodies certain on the membrane. A shade band will present up when
antigen-conjugate is deposited on the Check “T” place and the Management “C” place on the machine.

【COMPONENT】
Supplies offered: COMPON
ENT
20Exams
/Package 40Exams
/Package Fundamental
elements Check card
20
Exams/Package (1Test/bag ×20 Baggage)
40
Exams/Package (1Test/bag ×40 Baggage)
The
anti-nucleocapsid
protein antibody
and rooster IgY
labeled by
colloidal gold, the nitrocellulose membrane coated
with
anti-nucleocapsid
protein antibody
and goat anti-chicken IgY
antibody. Desiccant 20 packs 40 packs Silica Gel
Buffer 20
single-use bottles, every with
350 μL
extraction
buffer
40
single-use bottles, every with
350 μL
extraction
buffer Detergent answer Extraction
tube 20
single-use
response
tubes, every with 1x
nozzle cap
40
single-use
response
tubes, every with 1x
nozzle cap
/
Specimen
sampling
swabs 20 sterile, single-use
specimen
sampling
swabs 40 sterile, single-use
specimen
sampling
swabs
/
Supplies required however not supplied with the package: SARS-CoV-2 (+)
Management Swab
1 every –
individually wrapped for single-use Non-infectious, recombinant viral
protein antigen with
lower than 0.1%
sodium azide. SARS-CoV-2 (–)
Management Swab
1 every –
individually wrapped for single-use Buffer with much less
than 0.1% sodium
azide.

【STORAGE AND STABILITY】
1.Retailer at 2~30ºC within the sealed pouch as much as the expiration date
and the validity is tentatively 24 months. Don’t freeze. 2.The take a look at cassette must be used inside 1 hour after taking
out from the aluminum foil bag. 3.Avoid daylight, moisture, and warmth. 【SPECIMEN COLLECTION AND HANDLING】
1.Specimen Assortment and Preparation Acceptable specimens for testing with this package embrace nasal swab specimens obtained by the twin nares assortment methodology. Appropriate specimen assortment and preparation strategies have to be
adopted. Specimens obtained early throughout symptom onset will include the best viral titers; specimens obtained after
5 days of signs usually tend to produce detrimental
outcomes when in comparison with an RT-PCR assay. Insufficient
specimen assortment, improper specimen dealing with and/or
transport might yield a falsely detrimental outcome; due to this fact, coaching in specimen assortment is very really helpful resulting from
the significance of specimen high quality for producing correct take a look at outcomes. 2.Specimen Transport and Storage Freshly collected specimens must be processed as quickly as doable, however no later than one hour after specimen assortment. Appropriate specimen assortment and preparation strategies have to be
adopted. 3.Nasal Swab Specimen Assortment a. Insert the swab into one nostril of the affected person. The swab
tip must be inserted as much as 2.5
cm (1 inch) from the sting of
the nostril. Roll the swab 5
instances alongside the mucosa inside
the nostril to make sure that each mucus and cells are collected.
b. Utilizing the identical swab, repeat this course of for the opposite nostril to make sure that an
enough pattern is collected
from each nasal cavities. c. Withdraw the swab from
the nasal cavity. The pattern is now prepared for processing utilizing
the package. 4.DOs and DON’Ts of Pattern Assortment  Do acquire samples as quickly as doable after the onset of signs.  Do take a look at samples instantly.  Use solely swabs supplied with the package.  Don’t place the swab again into the swab packaging
sleeve after specimen assortment.

【TEST PROCEDURE】
1.The take a look at package, the specimen have to be at room temperature
(15~30ºC) for earlier than testing. The package is barely meant for nasal swab specimens which might be collected and examined straight (i.e., swabs which have NOT been positioned in transport media). The package
features a pre-diluted processing reagent in a prepared to make use of buffer bottle. This package IS NOT INTENDED for testing liquid
samples corresponding to a wash or aspirate samples or swabs in
transport media as outcomes will be compromised by over dilution. 2.Freshly collected specimens must be processed inside 1
hour. •Step 1: Twist of the highest of the buf er bottle, slowly dispense all of
the buf er into the extraction Tube. •Step 2: After assortment of nasal (NS) swab specimen, insert the swab
into the tube and plunge the
swab up and down within the fluid
for no less than 20 seconds, then maintain the swab towards the underside of the tube and roll 5
turns, taking care to not splash
contents out of the tube. •Step 3: Take away the swab whereas
squeezing the perimeters of the tube to
extract the liquid from the swab. •Step 4: Press the nozzle cap firmly onto
the extraction tube containing
the processed pattern (threading
or twisting shouldn’t be required). Combine
totally by swirling or
flicking the underside of the tube.
Place the extraction tube(s) in a
rack within the designated space of the workspace. •Step 5
Tear of the foil pouch, take out the take a look at strip/cassette and
place the take a look at package on a clear
and stage floor. Label the
take a look at machine and one extraction
tube for every specimen or management to be examined. •Step 6
Gently squeeze the ridged
physique of the tube, dishing out
three (3) drops of the processed specimen into the
pattern properly. •Step 7
Learn the take a look at outcomes between
15 and 20 minutes. Don’t learn the outcomes after 20 minutes. NOTE: Don’t use tubes or ideas from some other product, or
from different producers.

【INTERPRETATION OF TEST RESULTS】
1.POSITIVE: Two strains seem. A coloured line must be in
the management line area (C), a coloured line seems within the take a look at
line (T) area. Constructive outcomes point out the presence of viral antigens, however the scientific correlation with affected person historical past and
different diagnostic info is critical to find out
an infection standing. Constructive outcomes don’t rule out a bacterial
an infection or co-infection with different viruses. The agent detected might not be the particular reason for illness. 2.NEGATIVE: Just one coloured management line seems. Destructive outcomes are presumptive. Destructive take a look at outcomes don’t preclude an infection and shouldn’t be used as the only real foundation for
therapy or different affected person administration choices, together with
an infection management choices, significantly within the presence of scientific indicators and signs in step with COVID-19, or in
those that have been involved with the virus. It’s
really helpful that these outcomes be confirmed by a molecular
testing methodology, if essential, for affected person administration. 3.INVALID: Management line fails to look. Inadequate buffer quantity or incorrect procedural methods are the probably
causes for management line failure. Evaluation the process and
repeat the process with a brand new take a look at cassette. If the issue
persists, discontinue utilizing the take a look at package instantly and make contact with your native distributor. 4.End result dedication time: The outcome must be judged inside 15~20 minutes after the pattern is added into the
pattern properly, and the outcome displayed after 20 minutes is
invalid.
(The image is for reference solely)

【LIMITATIONS OF TEST METHOD】
1.This product is barely appropriate for a qualitative take a look at and
auxiliary analysis.
2.The take a look at outcomes are just for scientific reference and shouldn’t be the one foundation for scientific analysis and therapy. The
scientific administration of sufferers must be thought of in
mixture with their signs, bodily indicators, medical
historical past, different laboratory assessments, therapeutic response, and
epidemiological info. 3.Customers ought to take a look at specimens as rapidly as doable after specimen assortment. 4.Constructive take a look at outcomes don’t rule out co-infections with different pathogens. 5.Outcomes from the take a look at must be correlated with the scientific
historical past, epidemiological knowledge, and different knowledge out there to the
clinician evaluating the affected person. 6.A false-negative take a look at outcome might happen if the extent of viral antigen in a pattern is under the detection restrict of the take a look at or if
the pattern was collected or transported improperly; due to this fact, a detrimental take a look at outcome doesn’t eradicate the potential for
SARS-CoV-2 an infection. 7.The quantity of antigen in a pattern might lower because the period of sickness will increase. Specimens collected after day 5
of sickness usually tend to be detrimental in comparison with an RT-PCR assay. 8.Failure to comply with the take a look at process might adversely have an effect on take a look at efficiency and/or invalidate the take a look at outcome. 9.The contents of this package are for use for the qualitative detection of SARS-CoV-2 antigens from nasal swab
specimens solely. 10.The package efficiency relies on antigen load and will not correlate with different diagnostic strategies carried out on the
identical specimen. 11.Destructive take a look at outcomes aren’t meant to rule in different non-SARS-CoV-2 viral or bacterial infections. 12.Constructive and detrimental predictive values are extremely
depending on prevalence charges. Constructive take a look at outcomes are extra
more likely to characterize false-positive outcomes in periods of
little/no SARS-CoV-2 exercise when illness prevalence is low. False-negative take a look at outcomes are extra possible when the prevalence of illness brought on by SARS-CoV-2 is excessive. 13.This package has been evaluated to be used with human specimen materials solely. 14.Monoclonal antibodies might fail to detect or detect with much less
sensitivity, SARS-CoV-2 viruses which have undergone minor amino acid modifications within the goal epitope area. 15.The efficiency of this take a look at has not been evaluated to be used
in sufferers with out indicators and signs of respiratory
an infection and efficiency might differ in asymptomatic
people. 16.The sensitivity of the take a look at after the primary 5 days of the onset of signs has been demonstrated to lower as in comparison with an RT-PCR SARS-CoV-2 assay. 17.Destructive outcomes must be handled as presumptive and
confirmed with an FDA licensed molecular assay, if essential, for scientific administration, together with an infection
management. 18.Specimen stability suggestions are based mostly upon
stability knowledge from influenza testing and efficiency could also be totally different from SARS-CoV-2. Customers ought to take a look at specimens as rapidly as doable after specimen assortment, and inside one hour after specimen assortment. 19.The validity of the package has not been confirmed for
identification/affirmation of tissue tradition isolates and
shouldn’t be used on this capability.

【PERFORMANCE CHARACTERISTICS】
1.Scientific Efficiency The efficiency of the package was established with 310 direct nasal swabs prospectively collected and enrolled from
particular person symptomatic sufferers (inside 5 days of onset) who have been suspected of COVID-19. As with all antigen assessments, efficiency might lower as days since symptom onset
will increase. Samples have been collected by certified personnel in China.
Nasal swabs have been collected following the twin nares methodology
and dealt with as described within the instruction of the package. Specimens have been frozen inside 30 minutes of assortment and
saved till examined. All specimens inside a pre-specified date
vary have been chosen after which sequentially examined in a blinded
vogue. The efficiency of the package was in comparison with outcomes of a nasopharyngeal or oropharyngeal swab examined with a
commercialized molecular assay. The package confirmed 81.48% of sensitivity and 99.01% of specificity. Desk 1. Scientific Research Outcomes from symptom onset Reagent take a look at outcomes PCR Comparator po Subtotal sitive detrimental constructive 88 2 90
detrimental 20 200 220
Subtotal 108 202 310
Constructive P.c Settlement (PPA)= 88/108(81.48%)
(95%CI:72.9%~88.3%)
Destructive P.c Settlement (NPA)= 200/202 (99.01%)
(95%CI:96.5%~99.9%)
Accuracy=(88+200)/310×100%=92.90%
Kappa=2×17560/41940=0.84>0.5
2.Assay Cross-Reactivity
Cross-Reactivity: There was no cross-reaction with potential cross-reactive substances besides SARS-coronavirus. Desk 2: Cross-reactivity Outcomes Potential
Cross-Reactant Focus Examined
Cross-Reactivity
(Sure/No)
Influenza A
1.6 x 10
5 TCID50/mL NO
Influenza B
1.6 x 10
5 TCID50/mL NO
Human coronavirus HKU1
1.6 x10
5 TCID50/mL NO
Human coronavirus OC43
1.6 x10
5 TCID50/mL NO
Haemophilus
influenzae 2.2x 10
5 TCID50/mL NO
MERS-coronavirus 2.1 x 10
5 TCID50/mL NO
SARS-coronavirus 3.2 x 10
5 PFU/mL YES
Adenovirus C1
1.5 x 10
5 TCID50/mL NO
Adenovirus 71
1.5 x 10
5 TCID50/mL NO
Candida albicans 4.2 x 10
5 CFU/mL NO
Respiratory
syncytial virus 5.1 x 10
5 TCID50/mL NO
Enterovirus 5.Four x 10
5 TCID50/mL NO
Malaria 2.2 x 10
6 CFU/mL NO
Dengue 1.2 x 10
5 TCID50/mL NO
Human coronavirus NL63
1.7x 10
5 TCID50/mL NO
Human coronavirus 229E
2.2 x 10
5 TCID50/mL NO
Streptococcus pneumoniae 1.1 x 10
6 CFU/mL NO
Pneumocystis 1.Zero x 10
5 NO
jirovecii TCID50/mL
Legionella pneumophila 1.Four x 10
6 CFU/mL NO
Chlamydia pneumoniae 1.1 x 10
6 IFU/mL NO
Human Metapneumovirus
(hMPV)
1.1 x
10
5TCID50/mL NO
Parainfluenza virus 1
1.Zero x 10
5 TCID50/mL NO
Parainfluenza virus 2
1.Zero x 10
5 TCID50/mL NO
Parainfluenza virus 3
3.5 x 10
5 TCID50/mL NO
Parainfluenza virus 4
1.Four x 10
5 TCID50/mL NO
Rhinovirus 1.Three x 10
5 PFU/mL NO
Mycoplasma pneumoniae 1.Eight x 10
6 CFU/mL NO
Bordetella pertussis 1.5 x 10
6 CFU/mL NO
Mycobacterium
tuberculosis 1.Zero x 10
6 CFU/mL NO
Pooled human nasal wash-representative of regular respiratory microbial flora 100% NO
Streptococcus pyogenes 1.Zero x 10
6 CFU/mL NO
3.Doubtlessly Endogenous Interfering Substances SARS-CoV-2 Antigen nasal swab samples have been spiked with
one of many following substances to specified concentrations and examined in a number of replicates. No false positivity or false negativity was discovered with the next: Interfering
substances concent ration
Interfering
substances concent ration Complete Blood 5%
Naso GEL(Nei
Med)
6percentv/v Fluticasone Propionate 4percentv/v Mucin 0.54%
CVS Nasal Drops
(Phenylephrine) 17%v/v Ricola(Ment hol)
1.6mg/ mL
Tamiflu(Oseltamivir Phosphate) 6mg/ml Afrin(Oxym
etazoline) 14%v/v Sucrets(Dyclonin/M
enthol)
1.Four mg/mL
CVC Nasal
Spray(Crom
olyn)
16%v/v Chloraseptic(Mentho
l/Benzocaine)
1.Eight mg/mL
Nasal
Gel(Oxymet azoline)
9percentv/v Homeopathic(Alkalo
l)
1:10dil ution Mupiro
cin
12 mg/mL
Ore Throat Phenol
Spray
16%v/v Fisherm
an’s Buddy
1.3mg/ ml
Tobramycin
5
ug/mL
Zicam 4percentv/v
4.Restrict of Detection(ANALYTICAL SENSITIVITY)
The LOD for the SARS-CoV-2 antigen speedy take a look at package is 1.Three x
10
3TCID50/mL. The LOD for the SARS-CoV-2 antigen speedy take a look at package was established utilizing limiting dilutions of a viral pattern
inactivated by gamma irradiation. The fabric was provided
at a focus of 1.Three x 10
6 TCID50/mL. On this examine, designed to estimate the LOD of the assay when utilizing a direct
nasal swab, the beginning materials was spiked right into a quantity of virus dilution in saline. An preliminary range-finding examine was carried out testing gadgets in triplicate utilizing a 10-fold dilution
sequence. At every dilution, 50 μL samples have been added to swabs after which examined utilizing the process applicable for affected person nasal swab specimens. A focus was chosen between
the final dilution to offer Three constructive outcomes and the primary to offer 3
detrimental outcomes. Utilizing this focus, the LOD was
additional refined with a 2-fold dilution sequence. The final dilution
demonstrating 100% positivity was then examined in a further
20 replicates examined in the identical approach. 5.Hook Impact: As a part of the LoD examine, the best focus of the
pattern (1.Three x 10
6 TCID50/mL) was examined. There was no Hook
impact detected.

【WARNINGS】
1.A detrimental outcome can happen if the SARS-CoV-2 virus current
within the specimen is under the sensitivity of the package. 2.Not for the screening of donated blood. 3.Don’t smoke, drink, or eat in areas the place specimens or package reagents are being dealt with. 4.Eliminate all specimens and supplies used to carry out the
take a look at as biohazardous waste. 5.Deal with the detrimental and constructive controls in the identical method as affected person specimens for operator safety. 6.Don’t carry out the take a look at in a room with robust airflow, i.e. an
electrical fan or robust air-conditioning