TEST RÁPIDO DE ANTÍGENOS 25 ud.
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TE
STRÁPI
DODEANTÍ
GENOS25ud.
Declaration of Conformity
ACON Laboratories, Incorporated
5850 Oberlin Drive, #340
San Diego, CA 92121, USA
We, the manufacturer, declare under our sole responsibility that
the in vitro diagnostic device:
Flowflex® SARS-CoV-2 Antigen Rapid Test (L031-11815)
classified as Others in the directive 98/79/EC,
meets all the provisions of the directive 98/79/EC on in vitro diagnostic
medical devices which apply to it
The self-declaration is according to Annex III
(excluding Section 6) of the Directive.
Authorized Representative:
Medical Device Safety Service GmbH
Schiffgraben 41
30175 Hannover, Germany
Signed this 13 day of October, 2020
in San Diego, CA, USA
Qiyi Xie, MD, MPH
Senior Staff, Regulatory Affairs & Clinical Affairs
Acon Laboratories, Inc.
5850 Oberlin Drive, #340 · San Diego, CA 92121, USA · Tel: (858) 875-8000 · Fax: (858) 875-8099
E-mail: info@aconlabs.comFlowflexTM SARS-CoV-2 Antigen Rapid Test
Evaluation Report
November 2020Flowflex SARS-CoV-2 Antigen Rapid Test Evaluation Report
The Flowflex SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the
qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens
directly from individuals who are suspected of COVID-19 by their healthcare provider within the first seven
days of the onset of symptoms. The Flowflex SARS-CoV-2 Antigen Rapid Test does not differentiate
between SARS-CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid antigen. This antigen is generally detectable
in upper respiratory samples during the acute phase of infection. Positive results indicate the presence of
viral antigens, but clinical correlation with patient history and other diagnostic information is necessary
to determine infection status. Positive results do not rule out bacterial infection or co-infection with other
viruses. The agent detected may not be the definite cause of disease.
Negative results from patients with more than seven days post symptom onset should be treated as
presumptive and confirmed with a molecular assay, if necessary, for patient management. Negative
results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or
patient management decisions, including infection control decisions. Negative results should be
considered in the context of a patient s recent exposures, history and the presence of clinical signs and
symptoms consistent with COVID-19.
The Flowflex SARS-CoV-2 Antigen Rapid Test is intended for use by trained clinical laboratory personnel
and individuals trained in point of care settings.
1. Purpose: To evaluate the performance of the Flowflex SARS-CoV-2 Antigen Rapid Test
2. Material:
Materials Lot
SARS-CoV-2 Antigen Rapid Test 202009101 202009001 202009201
Extraction Buffer 202008001 202008002 202008003
3. Study procedure and results
3.1 Imprecision/reproducibility Study
Material:
SARS-CoV-2 Antigen Rapid Test, Lot#1:202009101, Lot#2:202009001, Lot#3:202009201
Extraction Buffer, Lot1#:202008001, Lot2#:202008002, Lot3#:202008003
SARS-CoV-2 Antigen Negative Sample Lot#: COVAG200904N
SARS-CoV-2 Antigen Low Positive Sample P3 Lot#: COVAG200904P3
SARS-CoV-2 Antigen Middle Positive Sample P2 Lot#: COVAG200904P2
SARS-CoV-2 Antigen High Positive Sample P1 Lot#: COVAG200904P1
2Procedure:
3 Lots of SARS-CoV-2 Antigen Rapid Test were tested according to the package insert by
3 operators. Each operator performed 2 tests on each control for 5 days in 2 sites in China.
Total 180 tests were performed per each control: 2 replicates X 5 days X 3 lots X 3
operators X 2 sites = 180 tests.
Test results:
SARS-CoV-2 Lot 1 Lot 2 Lot 3
Samples
High Pos + / 60 replicates + / 60 replicates + / 60 replicates
Mid Pos + / 60 replicates + / 60 replicates + / 60 replicates
Low Pos + / 60 replicates + / 60 replicates + / 60 replicates
Neg - / 60 replicates - / 60 replicates - / 60 replicates
Conclusions:
All three lots identified the samples 100% correctly as negative or positive.
3.2 Limit of Detection (LOD)
Material:
SARS-CoV-2 Antigen Rapid Test, Lot#1:202009101, Lot#2:202009001, Lot#3:202009201
Extraction Buffer, Lot1#:202008001, Lot2#:202008002, Lot3#:202008003
SARS-CoV-2 viral culture
Procedure:
1. Sample Application Method: Apply 4~5 drops (approximately 100~125 ul) of sample to
the sample well on the test cassette, then start the timer, read the result at 15-20 minutes.
2. Dilute the high concentration SARS-CoV-2 viral culture with the Extraction Buffer.
3. Use 3 lots of SARS-CoV-2 antigen rapid test to test the samples, and every sample is tested
in 10 replicates. Calculate the detectable rate for each sample.
4. The minimum concentration with detectable rate is defined as the minimum
detectability (LOD).
Test results:
Culture sample:
Detectable
Concentration Lot Test Result
rate
Lot 1 + / 10 replicates
2.56 x 103 100%
Lot 2 + / 10 replicates
TCID50/mL (30/30)
Lot 3 + / 10 replicates
Lot 1 + / 10 replicates
3
1.28 x 10 100%
Lot 2 + / 10 replicates
TCID50/mL (30/30)
Lot 3 + / 10 replicates
3Lot 1 + / 10 replicates
2
6.4 x 10 100%
Lot 2 + / 10 replicates
TCID50/mL (30/30)
Lot 3 + / 10 replicates
Lot 1 + / 10 replicates
2
3.2 x 10 100%
Lot 2 + / 10 replicates
TCID50/mL (30/30)
Lot 3 + / 10 replicates
Lot 1 + / 10 replicates
1.6 x 102 96.7%
Lot 2 + / 10 replicates
TCID50/mL (29/30)
Lot 3 + 9 replicates / - 1 replicate
Lot 1 - / 10 replicates
8 x 10
Lot 2 - / 10 replicates 0% (0/30)
TCID50/mL
Lot 3 - / 10 replicates
Conclusion:
According to the test result, the LOD is 1.6 x 102 TCID50/mL
3.3 Clinical study – nasal swabs
A multi-site clinical study was conducted to evaluate the performance of the SARS-CoV-2
Antigen Rapid Test, and the results are shown below.
Site 1 Material:
SARS-CoV-2 Antigen Rapid Test, Lot# 202009001
Comparison method: RT-PCR, Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit
(PCR-Fluorescence Probing), manufactured by Sansure BioTech Inc.
Extraction Buffer, Lot1#:202008001
Nasal swab samples from infected patients and non-infected patients
Site 1 Procedure:
1. Study was conducted in Hangzhou, China
304 clinical nasal swabs were collected from patients who were suspected of
COVID-19 (within 7 days of onset). All the samples were confirmed with RT-PCR.
34 positive clinical nasal swabs collected from patients. 29 samples with Ct counts2. Following product package insert, performed the test and read the result at 15-20
minutes.
Test results:
Candidate method RT-PCR method
Negative Positive* Total
Flowflex Negative 269 1 270
Test Positive 1 33 34
Results Total 270 34 304
Site 2 Material:
SARS-CoV-2 Antigen Rapid Test, Lot# 202009001
Comparison method: TaqPath COVID-19 Combo Kit, FDA authorized RT-PCR test for
emergency use, manufactured by Thermo Fisher Scientific, Inc.
Nasal swab samples from infected patients and non-infected patients
Site 2 Procedure:
1. Study is being conducted in multiple U.S. sites in California and Florida, and it is ongoing.
So far, 125 clinical nasal swabs were collected from patients who were suspected of
COVID-19 (within 7 days of onset). All the samples were confirmed with RT-PCR method.
2. Following product package insert, performed the test and read the result at 15-20
minutes.
Test results:
Candidate method RT-PCR method
Negative Positive Total
Flowflex Negative 32 3* 35
Test Positive 1 89 90
Results Total 33 92 125
*3 samples with PCR CT value 33.97 – 33.99
Summary of combined clinical studies at all sites:
Candidate method RT-PCR method
Negative Positive Total
Flowflex Negative 301 4 305
Test Positive 2 122 124
Results Total 303 126 429
5Conclusions:
The sensitivity, specificity, and accuracy are meeting MHRA acceptable requirement, which
has sensitivity greater than 80% and specificity greater than 95%.
Performance 95% CI
Sensitivity 96.8% 92.1%-
(122/126) 99.1%
Specificity 99.3% 97.6%-
(301/303) 99.9%
Accuracy 98.6% 97.0%
(423/429) -99.5%
3.4 Endogenous Interfering Substances
To determine if the substances that naturally present in respiratory specimens or that may
be artificially introduced into the nasal cavity interfere with Flowflex SARS-CoV-2 Antigen
Test.
Material:
SARS-CoV-2 Antigen Rapid Test, Lot# 202009001
Heat inactivated SARS-CoV-2 virus: Isolate USA-WA1/2020, Cat# 0810587CFHI,
Lot#324615
Extraction Buffer, Lot# 102820
Pooled human negative clinical matrix
Procedure 1: Test the endogenous substances in the absence of heat inactivated SARS-Cov-
2 virus.
The samples were prepared by spiking each substance into the human negative clinical
matrix to the target concentration listed in the table below. Each sample was tested in
triplicate with Flowflex SARS-CoV-2 Antigen Test according to the package insert.
Test Results:
No cross-reactivity was observed with the endogenous interfering substances when tested
at the concentration presented in the table below.
Procedure 2: Test the endogenous substances in the presence of heat inactivated SARS-CoV-
2 virus.
The samples were prepared by spiking each substance and heat inactivated SARS-Cov-2
virus into the human negative clinical matrix to the target concentration in the presence of
heat inactivated SARS-CoV-2 virus at 9.71 x 102 TCID50/mL. Each sample was tested in
triplicate according to the package insert.
Test Results:
6No interference was observed.
Endogenous Interference Substances Study Results
Cross-
Interference
Interfering Substances Active Ingredient Concentration Reactive
Results
Results
Mucin 0.5% w/v - - - + + +
Endogenous
Whole Blood 4% v/v - - - + + +
Afrin Original Nasal Spray Oxymetazoline 15% v/v - - - + + +
ALKALOL Allergy Relief Nasal Spray Homeopathic 1:10 Dilution - - - + + +
Menthol,
Chloraseptic Max Sore Throat Lozenges 1.5 mg/mL - - - + + +
Benzocaine
CVS Health Fluticasone Propionate Fluticasone
5% v/v - - - + + +
Nasal Spray propionate
Equate Fast-Acting Nasal Spray Phenylephrine 15% v/v - - - + + +
Equate Sore Throat Phenol Oral
Phenol 15% v/v - - - + + +
Anesthetic Spray
Original Extra Strong Menthol Cough
Menthol 1.5 mg/mL - - - + + +
Lozenges
NasalCrom Nasal Spray Cromolyn 15% v/v - - - + + +
NeilMed NasoGel for Dry Noses Sodium Hyaluronate 5% v/v - - - + + +
Dyclonine
Throat Lozenge 1.5mg/mL - - - + + +
Hydrochloride
Galphimia glauca,
Zicam Cold Remedy Luffa operculata, 5% v/v - - - + + +
Sabadilla
Antibiotic Mupirocin 10 mg/mL - - - + + +
Oseltamivir
Tamiflu 5 mg/mL - - - + + +
Phosphate
Antibiotic Tobramycin 4 ug/mL - - - + + +
Conclusion:
Based on the data generated by this study, the endogenous interfering substances tested do
not cross-react or interfere with Flowflex SARS-CoV-2 Antigen test.
73.5 Cross Reactivity (Analytical Specificity)
To demonstrate the related pathogens and organisms that are reasonably likely to be
present in the nasal cavity do not interfere with test performance of Flowflex SARS-Cov-2
Antigen Test.
Material:
SARS-CoV-2 Antigen Rapid Test, Lot#2:202009001
Extraction Buffer, Lot#102820
Pooled human negative clinical matrix
Procedure: Cross-Reactivity Wet Testing
Samples were prepared by spiking each stock inactivated viruses and bacteria into the pooled
human negative clinical matrix. Each organism and virus were tested in triplicate with Flowflex
SARS-CoV-2 Antigen Test.
Test Results:
No cross-reactivity was observed with the following bacteria and viruses when tested at the
concentration presented in the table below.
Test Cross-Reactive
Potential Cross -Reactant
Concentration Results
1.14 x 106
Adenovirus - - -
TCID50/mL
9.50 x 105
Enterovirus - - -
TCID50/mL
1.04 x 105
Human coronavirus 229E - - -
TCID50/mL
2.63 x 105
Human coronavirus OC43 - - -
Virus TCID50/mL
1.0 x 105
Human coronavirus NL63 - - -
TCID50/mL
1.25 x 105
Human Metapneumovirus - - -
TCID50/mL
7.90 x 105
MERS-coronavirus - - -
TCID50/mL
81.04 x 105
Influenza A - - -
TCID50/mL
1.04 x 105
Influenza B - - -
TCID50/mL
1.25 x 105
Parainfluenza virus 1 - - -
TCID50/mL
3.78 x 105
Parainfluenza virus 2 - - -
TCID50/mL
1.0 x 105
Parainfluenza virus 3 - - -
TCID50/mL
2.88 x 106
Parainfluenza virus 4 - - -
TCID50/mL
3.15 x 105
Respiratory syncytial virus - - -
TCID50/mL
3.15 x 105
Rhinovirus - - -
TCID50/mL
2.83 x 109
Bordetella pertussis - - -
CFU/mL
3.13 x 108
Chlamydia trachomatis - - -
CFU/mL
1.36 x 108
Haemophilus influenza - - -
CFU/mL
4.08 x 109
Legionella pneumophila - - -
CFU/mL
1.72 x 107
Mycobacterium tuberculosis - - -
CFU/mL
7.90 x 107
Mycoplasma pneumoniae - - -
Bacteria CFU/mL
2.32 x 109
Staphylococcus epidermidis - - -
CFU/mL
1.04 x 108
Streptococcus pneumoniae - - -
CFU/mL
4.10 x 106
Streptococcus pyogenes - - -
CFU/mL
Pneumocystis jirovecii-S. 8.63 x 107
- - -
cerevisiae CFU/mL
1.87 x 108
Pseudomonas aeruginosa - - -
CFU/mL
Pooled human nasal wash N/A - - -
8
1.57 x 10
Yeast Candida albicans - - -
CFU/mL
93.6 Microbial Interference Studies
To demonstrate that false negatives will not occur with Flowflex SARS-Cov-2 Antigen Test
when SARS-CoV-2 is present in a specimen with other microorganisms.
Material:
SARS-CoV-2 Antigen Rapid Test, Lot# 202009001
Heat inactivated SARS-CoV-2 virus: Isolate USA-WA1/2020, Cat# 0810587CFHI,
Lot#324615
Extraction Buffer, Lot#102820
Pooled human negative clinical matrix
Procedure:
The samples were prepared by spiking each inactivated viruses and bacterial cells and heat
inactivated SARS-CoV-2 virus into the pooled human negative clinical matrix. Each organism
and virus in the presence of heat inactivated SARS-CoV-2 virus at 9.71 x 102 TCID50/mL were
tested in triplicate with Flowflex SARS-CoV-2 Antigen Test.
Test Results:
No interference was observed in the presence of heat inactivated SARS-CoV-2 virus with the
following bacteria and viruses when tested at the concentration presented in the table below.
Test Interference
Potential Cross -Reactant
Concentration Results
1.14 x 106
Adenovirus + + +
TCID50/mL
9.50 x 105
Enterovirus + + +
TCID50/mL
1.04 x 105
Human coronavirus 229E + + +
TCID50/mL
2.63 x 105
Human coronavirus OC43 + + +
Virus TCID50/mL
1.0 x 105
Human coronavirus NL63 + + +
TCID50/mL
1.25 x 105
Human Metapneumovirus + + +
TCID50/mL
7.90 x 105
MERS-coronavirus + + +
TCID50/mL
101.04 x 105
Influenza A + + +
TCID50/mL
1.04 x 105
Influenza B + + +
TCID50/mL
1.25 x 105
Parainfluenza virus 1 + + +
TCID50/mL
3.78 x 105
Parainfluenza virus 2 + + +
TCID50/mL
1.0 x 105
Parainfluenza virus 3 + + +
TCID50/mL
2.88 x 106
Parainfluenza virus 4 + + +
TCID50/mL
3.15 x 105
Respiratory syncytial virus + + +
TCID50/mL
3.15 x 105
Rhinovirus + + +
TCID50/mL
2.83 x 109
Bordetella pertussis + + +
CFU/mL
3.13 x 108
Chlamydia trachomatis + + +
CFU/mL
1.36 x 108
Haemophilus influenza + + +
CFU/mL
4.08 x 109
Legionella pneumophila + + +
CFU/mL
1.72 x 107
Mycobacterium tuberculosis + + +
CFU/mL
7.90 x 107
Mycoplasma pneumoniae + + +
Bacteria CFU/mL
2.32 x 109
Staphylococcus epidermidis + + +
CFU/mL
1.04 x 108
Streptococcus pneumoniae + + +
CFU/mL
4.10 x 106
Streptococcus pyogenes + + +
CFU/mL
Pneumocystis jirovecii-S. 8.63 x 107
+ + +
cerevisiae CFU/mL
1.87 x 108
Pseudomonas aeruginosa + + +
CFU/mL
Pooled human nasal wash N/A + + +
8
1.57 x 10
Yeast Candida albicans + + +
CFU/mL
Conclusion:
11Based on the data generated by this study, the organisms or viruses tested do not cross-react
or interfere with Flowflex SARS-CoV-2 Antigen test.
3.7 Hook effect
To evaluate if the false negative result can be observed when test very high levels of heat
inactivated SARS-CoV-2 virus with Flowflex SARS-Cov-2 Antigen Test.
Material:
SARS-CoV-2 Antigen Rapid Test, Lot# 202009001
Heat inactivated SARS-CoV-2 virus: Isolate USA-WA1/2020, Cat# 0810587CFHI,
Lot#324615
Extraction Buffer, Lot#102820
Pooled human negative clinical matrix
Procedure:
Samples were prepared by adding heat inactivated SARS CoV-2 virus into the human negative
nasal matrix pool for preparing the highest concentration 7.5 x 105 TCID50/mL of heat
inactivated SARS-CoV-2 available in the human negative nasal matrix. Contrived nasal swab
samples were prepared by absorbing 50 uL of the virus at 7.5 x 105 TCID50/mL onto the swab.
The contrived swab samples were tested in triplicate according to the package insert.
Conclusion:
No high dose hook effect was observed when tested with up to a concentration of 7.5 x 105
TCID50/mL of heat inactivated SARS CoV virus with Flowflex SARS CoV Antigen Test.
3.8 Read Time Flex
To demonstrate that the test result is stable when read within the recommended time
window.
Material:
SARS-CoV-2 Antigen Rapid Test, Lot#1:COV0110005
Buffer, Lot#:TDE20110009
SARS-CoV-2 Antigen Negative Sample Lot#: 20201104
SARS-CoV-2 Antigen Low Positive Control Lot#: COVAG200930L
SARS-CoV-2 Antigen Middle Positive Control Lot#: COVAG200930M
ACON Rapid Flow Test Color Card, Lot#20200112
Procedure:
SARS-CoV-2 Antigen negative, high, middle and low positive sample are tested with SARS-
CoV-2 Antigen Rapid Test according to package insert. Each test was performed in triplicate.
The test results were recorded at 5, 10, 15, 20 and 30 mins.
12Test results:
SARS-CoV- 5 min 10 min 15 min 20 min 30 min
2 Samples
Neg -/3 -/3 -/3 -/3 -/3
replicates replicates replicates replicates replicates
Low Pos -/3 +/ 3 +/3 +/3 +/3
replicates replicates replicates replicates replicates
Mid Pos +/3 +/3 +/3 +/3 +/3
replicates replicates replicates replicates replicates
High Pos +/3 +/3 +/3 +/3 +/3
replicates replicates replicates replicates replicates
Conclusion:
The results are stable when read between 10 minutes to 30 minutes.
3.9 Stability Study
Material:
SARS-CoV-2 Antigen Rapid Test, Lot#1:202009101, Lot#2:202009001, Lot#3:202009201
Extraction Buffer, Lot1#:202008001, Lot2#:202008002, Lot3#:202008003
SARS-CoV-2 Antigen Negative Sample Lot#: COVAG200904N
SARS-CoV-2 Antigen Low Positive Sample P3 Lot#: COVAG200904P3
SARS-CoV-2 Antigen Middle Positive Sample P2 Lot#: COVAG200904P2
SARS-CoV-2 Antigen High Positive Sample P1 Lot#: COVAG200904P1
SARS-CoV-2 Antigen positive control swab, Lot#1: 202009003P-1, Lot#2: 202009003P-2,
Lot#3: 202009003P-3
SARS-CoV-2 Antigen negative control swab, Lot#1: 202009003N-1, Lot#2: 202009003N-
2, Lot#3: 202009003N-3
3.9.1 Accelerated stability
Estimate the shelf life for SARS-CoV-2 Antigen Rapid Test, Extraction Buffer and Control
Swabs basing on the accelerate stability study.
Procedure:
Accelerated stability study for three lots (including tests in individual pouches, control swabs
in individual pouches, extraction buffer in tube) will be stored at 55°C/65°C to estimate
product stability. Tests will be assayed according to package insert at designated time points.
For each device lot, run 3 replicates per sample at each time points. Read the results according
to package insert.
13Test results:
Result of SARS-CoV-2 Antigen Rapid Test
55°C
SARS-CoV-2 Samples 0 day 7 days 14 days
Neg - / 3 tests x 3 - / 3 tests x 3 - / 3 tests x 3
lots lots lots
Low Pos + / 3 tests x 3 + / 3 tests x 3 + / 3 tests x 3
lots lots lots
Mid Pos + / 3 tests x 3 + / 3 tests x 3 + / 3 tests x 3
lots lots lots
High Pos + / 3 tests x 3 + / 3 tests x 3 + / 3 tests x 3
lots lots lots
65°C
SARS-CoV-2 Samples 0 day 7 days 14 days
Neg - / 3 tests x 3 - / 3 tests x 3 - / 3 tests x 3
lots lots lots
Low Pos + / 3 tests x 3 + / 3 tests x 3 + / 3 tests x 3
lots lots lots
Mid Pos + / 3 tests x 3 + / 3 tests x 3 + / 3 tests x 3
lots lots lots
High Pos + / 3 tests x 3 + / 3 tests x 3 + / 3 tests x 3
lots lots lots
Result of SARS-CoV-2 Antigen Control swab:
55°C
Samples 0 day 7 days 14 days
Positive Control Swab + / 3 tests x 3 + / 3 tests x 3 + / 3 tests x 3
lots lots lots
Negative Control Swab - / 3 tests x 3 - / 3 tests x 3 - / 3 tests x 3
lots lots lots
65°C
Samples 0 day 7 days 14 days
Positive Control Swab + / 3 tests x 3 + / 3 tests x 3 + / 3 tests x 3
lots lots lots
Negative Control Swab - / 3 tests x 3 - / 3 tests x 3 - / 3 tests x 3
lots lots lots
Conclusion:
14SARS-CoV-2 Antigen Rapid Test, extraction buffer and SARS-CoV-2 Antigen Control Swabs are
stable at 65°C for 14 days, so the shelf life can be estimated at least 24 months.
3.9.2 Real time stability
Estimate the shelf life for SARS-CoV-2 Antigen Rapid Test, Extraction Buffer and Control
Swabs basing on the real time stability study.
Procedure:
Real time stability study for three lots (including tests in individual pouches, control swabs in
individual pouches, extraction buffer in tube) will be stored at 2-8°C/30°C to estimate product
stability. Tests will be assayed according to package insert at designated time points every 3
months until the timepoints that performance does not meet the acceptance criteria. For
each device lot, negative and different levels of positive samples will be tested, run 3
replicates per sample at each time points. Read the results according to package insert.
Acceptance criteria:
Negative sample will generate negative result
Low positive, medium positive and high positive sample will generate positive results
Test results:
Result of SARS-CoV-2 Antigen Rapid Test:
2-8°C
SARS-CoV-
Neg Low Pos Mid Pos High Pos
2 Samples
0 day - / 3 tests x 3 lots + / 3 tests x 3 lots + / 3 tests x 3 lots + / 3 tests x 3 lots
3 months
6 months
9 months
12 months
30°C
SARS-CoV-
Neg Low Pos Mid Pos High Pos
2 Samples
0 day - / 3 tests x 3 lots + / 3 tests x 3 lots + / 3 tests x 3 lots + / 3 tests x 3 lots
3 months
156 months
9 months
12 months
Result of SARS-CoV-2 Antigen Control swab:
2-8°C
SARS-CoV-2
Neg control swab Pos control swab
Samples
0 day - / 3 tests x 3 lots + / 3 tests x 3 lots
3 months
6 months
9 months
12 months
30°C
SARS-CoV-2
Neg control swab Pos control swab
Samples
0 day - / 3 tests x 3 lots + / 3 tests x 3 lots
3 months
6 months
9 months
12 months
Conclusion:
The real time stability of SARS-CoV-2 Antigen Rapid Test, extraction buffer and SARS-CoV-2
Antigen Control Swab are still in process. It is scheduled to finish in December 2022.
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
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para el SARS-CoV-2 no diferencia en re el SARS-CoV el SARS-CoV-2. extracción sin apretar.
desecharse de ac erdo con las norma i as locales.
Los res l ados ienen el obje i o de iden ificar el an geno de la n cleoc pside del SARS- 3. In rod ca el hisopo en el bo rem alo d ran e al menos 30 seg ndos. A
La h medad la empera ra p eden infl ir de forma nega i a en los res l ados.
CoV-2. Es e an geno generalmen e p ede de ec arse en las m es ras ob enidas de las con in aci n, g relo al menos cinco eces mien ras ejerce presi n en los la erales
Es e prospec o debe leerse por comple o an es de reali ar la pr eba. Si no se sig en
as respira orias s periores d ran e la fase ag da de la infecci n. Un res l ado posi i o del bo. Tenga c idado de no er er el con enido del bo.
las ins r cciones del prospec o, podr an prod cirse res l ados imprecisos en las pr ebas.
indica la presencia de an genos ricos, pero es necesario reali ar na correlaci n cl nica 4. Saq e el hisopo mien ras presiona los la erales del bo para e raerle el l q ido.
con el his orial del pacien e o ros da os diagn s icos para de erminar el es ado de ALMACENAMIENTO Y ESTABILIDAD
infecci n. Un res l ado posi i o no descar a las infecciones bac erianas ni las coinfecciones 5. Enrosq e firmemen e la apa del go ero en el bo de amp n de e racci n q e con iene
El ki p ede almacenarse a empera ras de en re 2 30 C.
con o ros ir s. El ir s de ec ado podr a no ser la ca sa final de la enfermedad. la m es ra. Me cle bien la m es ra remo iendo o agi ando la par e inferior del bo.
La pr eba man iene s es abilidad has a la fecha de cad cidad q e fig ra en la bolsa
Un res l ado nega i o en pacien es con s n omas ransc rridos sie e d as deber a ra arse sellada. 6. Saq e el case e de la pr eba de la bolsa de al minio selo lo an es posible. Los
como indicio confirmarse con n an lisis molec lar, si f era necesario, para poder ra ar La pr eba debe conser arse en la bolsa sellada has a s so. mejores res l ados se ob endr n si el an lisis se lle a a cabo lo an es posible ras la
al pacien e. Un res l ado nega i o no descar a el con agio del SARS-CoV-2 no debe NO CONGELAR. e racci n de la m es ra en un plazo máximo de una hora desde dicha e racci n.
emplearse como base nica para las decisiones rela i as al ra amien o o la ges i n de No sar ras la fecha de cad cidad. 7. Coloq e el case e de la pr eba sobre na s perficie plana limpia.
los pacien es, incl idas las decisiones rela i as al con rol de la infecci n. Los res l ados 8. Vier a la m es ra en el pocillo del case e de la pr eba
nega i os deben en enderse en el con e o de las e posiciones recien es del pacien e, MATERIALES
a. Desenrosq e la peq e a apa de la p n a del go ero.
s his orial la presencia de signos s n omas correspondien es a la COVID-19. Materiales suministrados b. In ier a el bo del amp n de e racci n con el ap n de go eo hacia abajo
El es r pido de an genos para el SARS-CoV-2 deben sarlo profesionales de Case es de pr eba T bos del amp n de e racci n s j elo en er ical (a apro imadamen e nos 2,5 cm del pocillo de la m es ra).
labora orios cl nicos formados personas formadas en ins alaciones de a enci n m dica. Hisopo de con rol posi i o Hisopo de con rol nega i o c. Aprie e el bo con s a idad ier a 4 go as de la m es ra procesada en el pocillo
RESUMEN Hisopos nasales es riles* Prospec o de la m es ra.
Los n e os corona ir s per enecen al g nero .1 La COVID-19 es na enfermedad * Los hisopos nasales est riles los produce otro fabricante. 9. Espere a q e apare ca(n) la(s) l nea(s) de color. El res l ado deber erse en
respira oria infecciosa ag da. Todas las personas presen an na predisposici n Materiales necesarios y no suministrados 15 - 30 min os. No lea al resultado una vez transcurridos 30 minutos.
general hacia ella. Ac almen e, los pacien es con agiados con el n e o corona ir s
Eq ipo de pro ecci n personal Tempori ador
represen an la principal f en e de infecci n; las personas con agiadas asin om icas
ambi n p eden ser na f en e de infecci n. De ac erdo con las in es igaciones EXTRACCI N DE MUESTRAS Y PREPARACI N
epidemiol gicas ac ales, el periodo de inc baci n d ra en re 1 14 d as; generalmen e El es r pido de an genos para el SARS-CoV-2 p ede reali arse sando m es ras
en re 3 7 d as. Los principales s n omas son la fiebre, el cansancio la os seca. ob enidas median e hisopos nasales.
Tambi n p ede obser arse en alg nos casos conges i n nasal, m cosidad nasal, dolor La pr eba debe reali arse de inmedia o ras la e racci n de la m es ra o en n pla o
de gargan a, mialgia diarrea. m imo de na (1) hora desde dicha e racci n.
PRINCIPIO Para e raer na m es ra median e hisopo nasal:
El es r pido de an genos para el SARS-CoV-2 es n inm noan lisis croma ogr fico 1. In rod ca con c idado n hisopo nasal es ril, que se
c ali a i o basado en membranas des inado a la de ecci n c ali a i a del an geno de la suministra en el kit, en n orificio nasal. Median e na
n cleoc pside del SARS-CoV-2 en m es ras h manas ob enidas median e hisopos s a e ro aci n, emp je el hisopo nos 2,5 cm desde el
nasales. borde del orificio nasal.
Al procesar las m es ras e incorporarlas al case e de la pr eba, los an genos del SARS-
CoV-2, de haberlos en la m es ra, reaccionar n con las par c las impregnadas de
an ic erpos fren e al SARS-CoV-2, q e se habr n impregnado pre iamen e en la ira
reac i a. A con in aci n, la me cla se despla a hacia arriba por la membrana median e 2. Gire el hisopo cinco eces ocando la m cosa del in erior
acci n capilar. Los complejos conj gados con el an geno se despla an por la ira del orificio nasal para garan i ar q e se e raiga na 4 gotas de la
reac i a hacia la ona de reacci n na l nea de fijaci n median e an ic erpos los muestra
m es ra s ficien e.
cap ra sobre la membrana. Los res l ados de la pr eba p eden obser arse a simple procesada
is a en 15 min os en f nci n de la presencia o a sencia de l neas de color.
Para con ar con n con rol del procedimien o, siempre aparecer na l nea de color en 15-30 min. Negativo Positivo No Válido
la regi n de la l nea de con rol para indicar q e se ha a incorporado el ol men de
m es ra adec ado q e la membrana ha a absorbido la s s ancia.INTERPRETACI N DE LOS RESULTADOS Rendimiento clínico del test rápido de antígenos para el SARS-CoV-2 ndice de símbolos
(Cons l e la il s raci n an erior) Método RT-PCR Resultados Con iene s ficien e para
NEGATIVO: solo aparece na l nea de color en la regi n de con rol (C). No aparecen Tes r pido de Resultados Nega i o Posi i o totales Fabrican e
pr ebas
l neas de color aparen es en la regi n de la l nea de la pr eba (T). Es o indica q e no se an genos para el Nega i o 269 1 270
han de ec ado an genos del SARS-CoV-2. Diagn s ico in vitro
SARS-CoV-2 Posi i o 1 33 34 IVD Fecha de cad cidad
POSITIVO:* Aparecen dos l neas de color diferen es. Una l nea en la regi n de la l nea disposi i o m dico
Resultados totales 270 34 304
de con rol (C) o ra en la regi n de la l nea de la pr eba (T). Es o indica q e se ha Cons l ar ins r cciones
de ec ado la presencia de an genos del SARS-CoV-2. Sensibilidad rela i a: 97,1 % (83,8 % - 99,9 %)* LOT C digo del lo e
an es de sar
* NOTA: La in ensidad del color de la l nea de la pr eba (T) p ede ariar en f nci n del Especificidad rela i a: 99,6 % (97,7 % - 99,9 %)*
ni el de an genos del SARS-CoV-2 presen es en la m es ra. Por lo an o, c alq ier Precisi n: 99,3 % (97,5 % - 99,9 %)*
L mi e de empera ra No re ili ar
onalidad de color en la regi n de la l nea de la pr eba (T) debe considerarse como n * 95% Intervalos de confianza
res l ado posi i o.
Límite de detecci n
NO V LIDO: no aparece la línea de control. Un ol men ins ficien e de la m es ra o REF N mero del ca logo Fecha de fabricaci n
El l mi e de de ecci n del es r pido de an genos para el SARS-CoV-2 se es ableci
n procedimien o incorrec o son los mo i os m s probables para q e no apare ca la
sando dil ciones res ric i as de na m es ra rica inac i a median e irradiaci n
l nea de con rol. Re ise el procedimien o repi a la pr eba con n case e de pr eba
gamma. La m es ra rica se enriq eci con na agr paci n de m es ras nasales Represen an e a ori ado en la Com nidad E ropea
n e o. Si el problema persis e, deje de sar el ki de pr eba de inmedia o p ngase en
h manas nega i as en dis in as concen raciones. Cada ni el se some i a pr ebas
con ac o con s dis rib idor local.
rela i as a 30 r plicas. Los res l ados mos raron q e el l mi e de de ecci n es de
CONTROL DE CALIDAD 1,6 102 TCID50/mL.
Tabela de Conte dos
En la pr eba se incl en con roles de procedimien os in ernos. La l nea de color q e Concentraci n del SARS-CoV-2 en muestra % Positivo (Pruebas)
aparece en la regi n de la l nea de con rol (C) es n con rol de procedimien os in erno. 1,28*103 TCID50/mL 100% (30/30) SARS-CoV-2 Antigen An geno del SARS-CoV-2
Es a confirma n ni el de m es ra s ficien e q e se ha a sado la cnica de so 6,4*102 TCID50/mL 100% (30/30)
correc a.
3,2*102 TCID50/mL 100% (30/30) Negative Control Swab Hisopo de con rol nega i o
Los hisopos de con rol nega i o posi i o se s minis ran con cada ki . Es os hisopos de
con rol deben sarse para garan i ar q e el case e de la pr eba el procedimien o de 1,6*102 TCID50/mL 96,7% (29/30)
la pr eba se empleen de manera adec ada. Siga las indicaciones de la secci n 8*10 TCID50/mL 0% (0/30) Positive Control Swab T bo del amp n de e racci n
INSTRUCCIONES DE USO para reali ar la pr eba de con rol. Interferencia y reactividad cruzada
LIMITACIONES No se obser reac i idad cr ada con las m es ras de pacien es con agiados con Extraction Buffer Tubes T bos del amp n de e racci n
1. El es r pido de an genos para el SARS-CoV-2 es des inado e cl si amen e a corona ir s-229E, corona ir s-NL63, corona ir s-OC43, corona ir s-HKU11, 2, ipo de
n so diagn s ico in vitro. Es a pr eba solo debe sarse para la de ecci n de ir s de la parainfl en a ( ipo 1, ipo 2, ipo 3 ipo 4), gripe por ir s A/B, rino ir s Disposable Swabs Hisopos nasales es riles
an genos del SARS-CoV-2 en m es ras ob enidas median e hisopos nasales. La h mano, boca ir s h mano, ir s sinci ial respira orio h mano, me apne mo ir s
in ensidad de la l nea de la pr eba no g arda necesariamen e na relaci n con la h mano, adeno ir s h mano, en ero ir s, Chlam dia pne moniae, Haemophil s Tes r pido de an genos para el SARS-
concen raci n rica del SARS-CoV-2 en la m es ra. infl en ae, Legionella pne mophila, M cobac eri m berc losis, S rep ococc s SARS-CoV-2 Antigen Rapid Test
CoV-2
2. Las m es ras deben some erse a la pr eba an pron o como sea posible ras s pne moniae, S rep ococc s p ogenes, Borde ella per ssis, M coplasma pne moniae,
e racci n, siempre en n pla o m imo de na hora ras es a e racci n. Candida albicans, corona ir s del s ndrome respira orio de Orien e Medio o
Pne moc s is jiro ecii.
3. El so de medios de ranspor e rico p ede conlle ar na red cci n de la
sensibilidad de la pr eba. El es r pido de an genos para el SARS-CoV-2 no diferencia en re el SARS-CoV el
SARS-CoV-2.
4. P ede prod cirse n res l ado falso nega i o si el ni el de an genos de la m es ra ACON Biotech (Hangzhou) Co., Ltd.
se enc en ra por debajo del l mi e de de ecci n de la pr eba o si la e racci n se Las s s ancias q e in erfieren (sangre, aerosol de clorhidra o de o me a olina de No.210 Zhenzhong Road, West Lake MedNet GmbH
reali de forma incorrec a. dafenlina, aerosol nasal de f roa o de mome asona, propiona o de fl icasona o District, Hangzhou, P.R.China, 310030 Borkstrasse 10
limpiador nasal fisiol gico de ag a marina) con na de erminada concen raci n no 48163 Muenster, Germany
5. Los res l ados de la pr eba deben combinarse con o ros da os cl nicos de los q e
in erfieren en la pr eba del es r pido de an genos para el SARS-CoV-2.
disponga el personal m dico.
6. Un res l ado posi i o no descar a coinfecciones con o ros pa genos. PRECISI N
7. Un res l ado posi i o no diferencia en re el SARS-CoV el SARS-CoV-2. Intraanalítica
8. Un res l ado nega i o no p ede descar ar o ras infecciones bac erianas o ricas. La precisi n den ro de na misma serie se de ermin sando 10 r plicas de m es ras:
9. Un res l ado nega i o en pacien es c os s n omas apare can desp s de sie e con roles posi i os de an genos del SARS-CoV-2 con rol nega i o. Las m es ras se
d as deber a ra arse como indicio confirmarse con n an lisis molec lar, si f era iden ificaron correc amen e en m s del 99 % de las ocasiones.
necesario, para poder reali ar la ges i n cl nica. Interanalítica
(Si es necesario es ablecer na diferenciaci n en re los dis in os ir s cepas La precisi n en re dis in as series se de ermin sando 10 an lisis independien es de la
espec ficos del SARS, deber n reali arse o ras pr ebas.) misma m es ra: m es ra posi i a de an genos del SARS-CoV-2 m es ra nega i a. Se
CARACTER STICAS DE RENDIMIENTO probaron res lo es diferen es de es s r pidos de an genos para el SARS-CoV-2 con es as
m es ras. Las m es ras se iden ificaron correc amen e en m s del 99 % de las ocasiones.
Precisi n, sensibilidad y especificidad clínicas
BIBLIOGRAF A
El rendimien o del es r pido de an genos para el SARS-CoV-2 se es ableci con
304 hisopos nasales e ra dos de pacien es independien es sin om icos (en n pla o 1. Sh o S , Gar Wong, Weifeng Shi, e al. Epidemiolog , Gene ic recombina ion, and
de sie e d as desde la aparici n de los s n omas) de los q e se sospechaba q e p dieran pa hogenesis of corona ir ses. Trends in Microbiolog , J ne 2016, ol. 24, No. 6:
es ar con agiados con la COVID-19. Los res l ados mos raron q e la sensibilidad 490-502.
rela i a la especificidad rela i a son las sig ien es: 2. S san R. Weiss, J lian L. Leibo i , Corona ir s Pa hogenesis, Ad ances in Vir s N mero: 1151248401
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