COVID-19 Antigen Rapid Test Cassette - Technical File (Saliva/Nasopharyngeal Swab) - SciChem
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COVID-19 Antigen Rapid Test Cassette Technical File (Saliva/Nasopharyngeal Swab)
SURESCREEN DIAGNOSTICS Contents 1. Information Of Manufacturer 3 2. Product Description 4 3. Technical Report 10 3.1. Sample Correlation 10 3.2. Interfering Substances 12 3.3. Cross Reactivity 15 3.4. Dose Hook 19 3.5. Detection Limit 21 3.6. Variability (Inter\Intra\Day To Day Assay) 24 3.7. Accelerated Stability 26 02 SURESCREEN DIAGNOSTICS
SURESCREEN DIAGNOSTICS 1. Information Of Manufacturer Name: SureScreen Diagnostics Ltd. Address: Unit 1 Prime Parkway, Prime Enterprise Park, Derby, DE1 3QB, UK Registration number: 3235601 VAT number: GB683963777 About us SureScreen Diagnostics is a family company established in 1996, which provides diagnostic tests to various industries around the world, including health services and other corporations. Such diagnostic tests include test strips (oral fluid, urine etc,) for drugs of abuse, glucose, pregnancy and infectious diseases. Furthermore, SureScreen has invested in research and development of advanced diagnostic technology, resulting in the launch of a range of electronic devices, for measuring, for example, blood alcohol. SureScreen also provides on-site health testing and training within organisations as part of their occupational health service. With ISO 9001 and 13485 certifications, SureScreen has a strong track record in the field of diagnostics and continues to grow. 03 SURESCREEN DIAGNOSTICS
SURESCREEN DIAGNOSTICS 2. Product Description 2.1 Product Name COVID-19 Antigen Rapid Test Cassette(Saliva/Nasopharyngeal Swab) 2.2 Brand Name SureScreen Diagnostics 2.3 Intended Use The COVID-19 Antigen Rapid Test Cassette (Saliva/Nasopharyngeal Swab) is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in Saliva and Nasopharyngeal Swab. The identification is based on the monoclonal antibodies specific for the Nucleocapsid (N) protein of SARS-CoV-2. It is intended to aid in the rapid differential diagnosis of COVID-19 infections. 2.4 Background The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. 2.5 Principles The COVID-19 Antigen Rapid Test Cassette (Saliva/Nasopharyngeal Swab) is a qualitative, lateral flow immunoassay for the detection of the N protein of SARS-CoV-2 in saliva and Nasopharyngeal Swab. In this test, antibody specific to the N protein of SARS-CoV-2 is separately coated on the test line regions of the test cassette. During testing, the extracted specimen reacts with the antibody to N protein of SARS-CoV-2 that are coated onto particles. The mixture migrates up the membrane to react with the antibody to N protein of SARS-CoV-2 on the membrane and generate one colored line in the test regions. The presence of this colored line of the test regions indicates a positive result. To serve as a procedural control, a colored line will always appear in the control region if the test has performed properly. 04 SURESCREEN DIAGNOSTICS
SURESCREEN DIAGNOSTICS
Figure 1: Test Principle
As shown in illustration above, the specimen (A) migrates via capillary action along the membrane to react
with the colored conjugate (B). COVID-19 antigen present in the specimen binds to the conjugate, forming
a colored antibody-antigen complex. The anti-SARS-CoV-2 Nucleocapsid protein immobilized in the test
zone of the membrane captures the test region (C). The formation of a visible colored line in the test region
indicates a positive result (C). The absence of a colored line in the test zones suggests a negative result.
In the control zone of the membrane, immobilized reagents capture colored conjugate regardless of test
specimen composition. The resulting visible colored band (D) confirms control line.
2.6 Performance and Specification
COVID-19 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative
lateral flow immunoassay for the detection of the Nucleocapsid (N) protein of SARS-CoV-2 in
nasopharyngeal swabs or Saliva. It is intended to aid in the rapid differential diagnosis of COVID-19
infections. Neither the quantitative value nor the rate of increase in Novel Coronavirus SARS-CoV-2
antigen can be determined by this qualitative test.
2.6.1 Precautions
• For professional in vitro diagnostic use only. Do not use after the expiration date.
• The test should remain in the sealed pouch until ready to use.
• All specimens should be considered potentially hazardous and handled in the same manner as an infection
agent.
• The used test should be discarded according to local regulations.
• Avoid using bloody samples.
• Wear gloves when handling the samples, avoid touching the reagent membrane and sample well.
2.6.2 Storage and Stability
Store as packaged at room temperature or refrigerated (2-30°C). The test is stable through the expiration
date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do
not use beyond the expiration date.
2.6.3 Specimen Collection and Preparation
The COVID-19 Antigen Rapid Test Cassette (Saliva/Nasopharyngeal Swab) can be performed using
Saliva and Nasopharyngeal Swab specimens. The quality of specimens obtained is of extreme
importance. Detection of COVID-19 Antigen requires a vigorous and thorough collection technique
that provides COVID-19 Antigen rather than just body fluids.
05 SURESCREEN DIAGNOSTICSSURESCREEN DIAGNOSTICS To collect Saliva Specimen: Use the collection tube to collect saliva. Open the cap of the collection tube. Install saliva collector, put the collection tube with saliva collector close to lips and let the saliva flow into the collection tube. The volume of saliva needs to be between two scale marks (approx. 150-300µl). If the volume of saliva is too much, use a dropper to remove the excess saliva until the final solution is between the two scale marks (approx. 150-300µl). To collect Nasopharyngeal swab Specimen: Insert swab through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx. Swab should reach depth equal to distance from nostrils to outer opening of the ear. Gently rub and roll the swab. Leave swab in place for several seconds to absorb secretions. Slowly remove swab while rotating it. Specimens can be collected from both sides using the same swab, but it is not necessary to collect specimens from both sides if the swab is saturated with fluid from the first collection. If a deviated septum or blockage create difficulty in obtaining the specimen from one nostril, use the same swab to obtain the specimen from the other nostril. 2.6.4 Standard Testing Procedure Allow the test, specimen, extraction buffer to equilibrate to room temperature (15-30°C) prior to testing. 1. Remove the test cassette from the sealed foil pouch and use it within one hour. Best results will be obtained if the assay is performed immediately after opening the foil pouch. 2. Extract the COVID-19 antigen according to the specimen type. > For Saliva Specimen: 3. Place the collection tube with saliva collector containing saliva in the workstation. Hold the extraction reagent bottle upside down vertically. Squeeze the bottle and let the solution drop into the extraction tube freely without touching the edge of the tube. Add all extraction buffer (Approx. 300uL) to the collection tube. 4. Discard the saliva collector, close the cap onto the specimen collection tube. Shake the specimen collection tube more than three times vigorously to mix the saliva and the extraction buffer, then squeeze the mixed solution ten times to allow the saliva to be thoroughly mixed. > For Nasopharyngeal Swab Specimen: 5. Place the collection tube in the workstation. Open the cap of the collection tube. Hold the extraction reagent bottle upside down vertically. Squeeze the bottle and let the solution drop into the extraction tube freely without touching the edge of the tube. Add all extraction buffer (Approx. 300uL) to the collection tube. 6. Place the swab specimen in the collection tube. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab. 7. Remove the swab while squeezing the swab head against the inside of the collection tube as you remove it to expel as much liquid as possible from the swab. Discard the swab in accordance with your biohazard waste disposal protocol. 8. Close the cap onto the specimen collection tube. 06 SURESCREEN DIAGNOSTICS
SURESCREEN DIAGNOSTICS 3. Place the test cassette on a clean and level surface. Invert the specimen collection tube and transfer 3 full drops of the extracted specimen (approximately 80µL) to the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). 4. Read the result at 10 minutes. Do not interpret the result after 20 minutes. 2.6.5 Interpretation Of Results 07 SURESCREEN DIAGNOSTICS
SURESCREEN DIAGNOSTICS POSITIVE:*Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T). A positive result indicates that COVID-19 was detected in the specimen. *NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of COVID-19 Antigen present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive. NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T). A negative result indicates that COVID-19 antigen is not present in the specimen, or is present below the detectable level of the test. INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor. 2.6.6 Quality Control A procedural control is included in the test. A colored line appearing in the control line region (C) is considered an internal procedural control. It confirms adequate membrane wicking. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance. 2.6.7 Limitations 1) The COVID-19 Antigen Rapid Test Cassette (Saliva/Nasopharyngeal Swab) is for professional in vitro diagnostic use only. The test should be used for the detection of COVID-19 Antigen in Saliva. Neither the quantitative value nor the rate of increase in SARS-CoV-2 virus concentration can be determined by this qualitative test. 2) The accuracy of the test depends on the quality of the saliva sample. False negatives may result from improper sample collection or storage. 3) The COVID-19 Antigen Rapid Test Cassette (Saliva/Nasopharyngeal Swab)will only indicate the presence of SARS-CoV-2 in the specimen from both viable and non-viable SARS-CoV-2 coronavirus strains. 4) As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician. 5) A negative result obtained from this kit should be confirmed by PCR. A negative result may be obtained if the concentration of the SARS-CoV-2 virus present in the saliva is not adequate or is below the detectable level of the test. 6) Excess blood or mucus on the saliva specimen may interfere with test performance and may yield a false positive result. 7) A positive result for COVID-19 does not preclude an underlying co-infection with another pathogen, therefore the possibility of an underlying bacterial infection should be considered. 8) Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. 9) Positive results may be due to current infection with acute non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43 or 229E. 10) Results from antigen testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. 11) Extraction reagent has the ability to kill the virus, but it cannot inactivate 100% of the virus. The method of inactivating the virus can be referred to: what method is recommended by WHO/CDC, or it can be handled according to local regulations. 08 SURESCREEN DIAGNOSTICS
SURESCREEN DIAGNOSTICS 2.7 User Professional 2.8 Bibliography 1. Weiss SR, Leibowitz JL. Coronavirus pathogenesis. Adv Virus Res 2011;81:85-164. 2. Cui J, Li F, Shi ZL. Origin and evolution of pathogenic coronaviruses. Nat Rev Microbiol 2019; 17:181-192. 3. Su S, Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. Trends Microbiol 2016;24:490-502. 09 SURESCREEN DIAGNOSTICS
SURESCREEN DIAGNOSTICS
3. Technical Report
3.1. Sample Correlation
Material
ICOVG-C81: COVG2007001-T, Exp:2022-07
COVG2007002-T, Exp:2022-07
COVG2007003-T, Exp:2022-07
The COVID-19 Antigen Rapid Test Cassette (Saliva/Nasopharyngeal Swab) has been evaluated with
specimens obtained from the patients. PCR is used as the reference method for The COVID-19 Antigen
Rapid Test Cassette (Saliva/Nasopharyngeal Swab). Specimens were considered positive if PCR indicated
a positive result.
Specimen collection and preparation
According to the Package Insert.
Method
The assay was performed according to the package insert. Specimens were rated as either positive or
negative at 10 minutes. Do not interpret the results after 20minutes. Results were presented in table below
Results
Lot# COVG2007001-T
PCR
Method
Total
Positive Negative
COVID-19 Antigen Rapid Positive 38 0 38
Test Cassette(Saliva/
Nasopharyngeal Swab) Negative 2 324 326
Total 40 324 364
Relative Sensitivity: 95.0% (95%CI*:83.1%-99.4%)*
Relative Specificity: 99.9% (95%CI*:99.1%-100.0%)*
Relative accuracy: 99.5% (95%CI*:98.0%-99.9%)*
* Confidence Intervals
Lot# COVG2007002-T
PCR
Method
Total
Positive Negative
COVID-19 Antigen Rapid Positive 38 0 38
Test Cassette(Saliva/
Nasopharyngeal Swab) Negative 2 324 326
Total 40 324 364
Relative Sensitivity: 95.0% (95%CI*:83.1%-99.4%)*
Relative Specificity: 99.9% (95%CI*:99.1%-100.0%)*
Relative accuracy: 99.5% (95%CI*:98.0%-99.9%)*
* Confidence Intervals
10 SURESCREEN DIAGNOSTICSSURESCREEN DIAGNOSTICS
Lot# COVG2007003-T
PCR
Method
Total
Positive Negative
COVID-19 Antigen Positive 38 0 38
Rapid Test Cassette
(Saliva) Negative 2 324 326
Total 40 324 364
Relative Sensitivity: 95.0% (95%CI*:83.1%-99.4%)*
Relative Specificity: 99.9% (95%CI*:99.1%-100.0%)*
Relative accuracy: 99.5% (95%CI*:98.0%-99.9%)*
* Confidence Intervals
Conclusion
The COVID-19 Antigen Rapid Test Cassette has been calibrated against specimens that have been collected
from individuals found to be either PCR positive/negative. The results were showed as blow:
Relative Sensitivity: 95.0% (95%CI*:83.1%-99.4%)*
Relative Specificity: 99.9% (95%CI*:99.1%-100.0%)*
Relative accuracy: 99.5% (95%CI*:98.0%-99.9%)*
* Confidence Intervals
11 SURESCREEN DIAGNOSTICSSURESCREEN DIAGNOSTICS
3.2. Interfering Substances
Material
ICOVG-C81: COVG2007001-T, Exp:2022-07
COVG2007002-T, Exp:2022-07
COVG2007003-T, Exp:2022-07
Recombinant antigen(Nucleocapsid(N) protein): Lot: 20201310-200323
Interfering Substances
Ambroxol Hydrochloride Tablets (7.5 mg/mL) Nasal antibioitic (Mupirocin Ointment)
Mometasone furoate nasal spray (0.05% g/g) Oxymetazoline Hydrochloride Spray
Cough syrup Beclomethasone Dipropionate Nasal Aerosol
Dextromethorphan Hydrobromide Oral Solution
Triamcinolone Acetonide Nasal Spray
(1.5 mg/ml)
MucosolvanAmbroxol Hydrochloride Oral Solution Azelastine Hydrochloride Nasal Spray
Nasal cleansing solution, NaCl (5 g/L) Fluticasone Propionate Nasal Spray
Kids Cold Cough Liquid Safe Natural Relief
Physiological Seawater Nasal Spray
Throat syrup Tobramycin Eye Drops
Listerine mouthwash Whole blood (4%)
Scope mouthwash Mucin (0.05%)
Method
1. Interfering substances 50ul and Buffer 300ul as negative. Take 80ul/sample. Test 3 replicates.
2.Dilute the recombinant antigen to 1ng/mL as SARS-CoV-2 High positive, 50pg/mL as SARS-CoV-2 low
positive with interfering substances and buffer (1:6). Take 80ul/sample. Test 3 replicates.
3.The result is judged with a Gold Color Card as the reading standard.
Result
Negative
COVG2007001-T COVG2007002-T COVG2007003-T
Ambroxol Hydrochloride Tablets
- - - - - - - - -
(7.5 mg/mL)
Mometasone furoate nasal spray
- - - - - - - - -
(0.05% g/g)
Cough syrup - - - - - - - - -
Dextromethorphan Hydrobromide Oral
- - - - - - - - -
Solution (1.5mg/ml)
MucosolvanAmbroxol Hydrochloride Oral
- - - - - - - - -
Solution
Nasal cleansing solution, NaCl (5 g/L) - - - - - - - - -
Kids Cold Cough Liquid Safe Natural
- - - - - - - - -
Relief
Throat Syrup - - - - - - - - -
Listerine mouthwash - - - - - - - - -
Scope mouthwash - - - - - - - - -
12 SURESCREEN DIAGNOSTICSSURESCREEN DIAGNOSTICS
Nasal antibioitic (Mupirocin Ointment) - - - - - - - - -
Oxymetazoline Hydrochloride Spray - - - - - - - - -
Beclomethasone Dipropionate Nasal
- - - - - - - - -
Aerosol
Triamcinolone Acetonide Nasal Spray - - - - - - - - -
Azelastine Hydrochloride Nasal Spray - - - - - - - - -
Fluticasone Propionate Nasal Spray - - - - - - - - -
Physiological Seawater Nasal Spray - - - - - - - - -
Tobramycin Eye Drops - - - - - - - - -
Whole blood (4%) - - - - - - - - -
Mucin (0.05%) - - - - - - - - -
SARS-CoV-2 Low sample(50pg/mL)
COVG2007001-T COVG2007002-T COVG2007003-T
Ambroxol Hydrochloride Tablets
+ + + + + + + + +
(7.5 mg/mL)
Mometasone furoate nasal spray
+ + + + + + + + +
(0.05% g/g)
Cough syrup + + + + + + + + +
Dextromethorphan Hydrobromide Oral
+ + + + + + + + +
Solution (1.5mg/ml)
MucosolvanAmbroxol Hydrochloride Oral
+ + + + + + + + +
Solution
Nasal cleansing solution, NaCl (5 g/L) + + + + + + + + +
Kids Cold Cough Liquid Safe Natural
+ + + + + + + + +
Relief
Throat Syrup + + + + + + + + +
Listerine mouthwash + + + + + + + + +
Scope mouthwash + + + + + + + + +
Nasal antibioitic (Mupirocin Ointment) + + + + + + + + +
Oxymetazoline Hydrochloride Spray + + + + + + + + +
Beclomethasone Dipropionate Nasal
+ + + + + + + + +
Aerosol
Triamcinolone Acetonide Nasal Spray + + + + + + + + +
Azelastine Hydrochloride Nasal Spray + + + + + + + + +
Fluticasone Propionate Nasal Spray + + + + + + + + +
Physiological Seawater Nasal Spray + + + + + + + + +
Tobramycin Eye Drops + + + + + + + + +
Whole blood (4%) + + + + + + + + +
Mucin (0.05%) + + + + + + + + +
SARS-CoV-2 High Positive(1ng/mL)
COVG2007001-T COVG2007002-T COVG2007003-T
Ambroxol Hydrochloride Tablets
+ + + + + + + + +
(7.5 mg/mL)
Mometasone furoate nasal spray
+ + + + + + + + +
(0.05% g/g)
Cough syrup + + + + + + + + +
Dextromethorphan Hydrobromide Oral
+ + + + + + + + +
Solution (1.5mg/ml)
MucosolvanAmbroxol Hydrochloride Oral
+ + + + + + + + +
Solution
Nasal cleansing solution, NaCl (5 g/L) + + + + + + + + +
Kids Cold Cough Liquid Safe Natural
+ + + + + + + + +
Relief
13 SURESCREEN DIAGNOSTICSSURESCREEN DIAGNOSTICS
Throat Syrup + + + + + + + + +
Listerine mouthwash + + + + + + + + +
Scope mouthwash + + + + + + + + +
Nasal antibioitic (Mupirocin Ointment) + + + + + + + + +
Oxymetazoline Hydrochloride Spray + + + + + + + + +
Beclomethasone Dipropionate Nasal
+ + + + + + + + +
Aerosol
Triamcinolone Acetonide Nasal Spray + + + + + + + + +
Azelastine Hydrochloride Nasal Spray + + + + + + + + +
Fluticasone Propionate Nasal Spray + + + + + + + + +
Physiological Seawater Nasal Spray + + + + + + + + +
Tobramycin Eye Drops + + + + + + + + +
Whole blood (4%) + + + + + + + + +
Mucin (0.05%) + + + + + + + + +
Note: “-”mean negative result “+” mean positive result
Conclusion
No substances above showed any interference with the test. There were no obvious differences among
the 3 lots of COVID-19 Antigen Rapid Test Cassette (Saliva/Nasopharyngeal Swab) products.
14 SURESCREEN DIAGNOSTICSSURESCREEN DIAGNOSTICS
3.3. Cross Reactivity
Materials
ICOVG-C81: COVG2007001-T Exp:2022-07, COVG2007002-T Exp:2022-07, COVG2007003-T Exp:2022-07
Cross-Reactive Substance: See table
Method
1. Cross reactivity 50ul + Buffer 300ul. Take 80ul/sample . Test 4 replicates.
2.The result is judged with a Gold Color Card as the reading standard. Results were presented in table
below.
Result
Table: Cross Reactivity
Part 1:
Product
LOT: LOT: LOT:
COVG2007001-T COVG2007002-T COVG2007003-T
Cross-reactive substance
Original
Name concentration
Final concentration No. Results No. Results No. Results
Test 1 - Test 1 - Test 1 -
Parainfluenza
1.6 x 104 Test 2 - Test 2 - Test 2 -
Virus 1.6 x 10
3
TCID50/
Type4a TCID50/mL Test 3 - Test 3 - Test 3 -
mL
#314951
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Human Test 2 - Test 2 - Test 2 -
2.8 x 106
Coxsackievirus 2.8 x 105TCID50/mL
TCID50/mL Test 3 - Test 3 - Test 3 -
#64316692
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Mumps virus 2.8x10 7
2.8 x 10
6 Test 2 - Test 2 - Test 2 -
#63875711 TCID50/mL TCID50/mL Test 3 - Test 3 - Test 3 -
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
20 x 1010 Test 2 - Test 2 - Test 2 -
1Rhinovirus 20 x 109
organisms/
#88/522 organisms/ml Test 3 - Test 3 - Test 3 -
ml
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Haemophilusparai Test 2 - Test 2 - Test 2 -
6x10 7
nfluenzae 6x106 bacterial/ml
bacterial/ml Test 3 - Test 3 - Test 3 -
#1123815
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Staphylococcus Test 2 - Test 2 - Test 2 -
6x10 7
aureus 6x106 bacterial/ml
bacterial/ml Test 3 - Test 3 - Test 3 -
#2786815
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Neisseria Test 2 - Test 2 - Test 2 -
meningitides 106 org/ml 105 org/ml
#5567815 Test 3 - Test 3 - Test 3 -
Test 4 - Test 4 - Test 4 -
15 SURESCREEN DIAGNOSTICSLOT: LOT: LOT:
SURESCREEN DIAGNOSTICS
COVG2007001-T COVG2007002-T COVG2007003-T
Cross-reactive substance
Original
Name concentration
Final concentration No. Results No. Results No. Results
Test 1 - Test 1 - Test 1 -
Streptococcus sp. Test 2 - Test 2 - Test 2 -
group A 109org/ml 108org/ml
#2015-11 Test 3 - Test 3 - Test 3 -
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Streptococcus sp. 6x107 Test 2 - Test 2 - Test 2 -
6x106bacterial/ml
group B #3625233 bacterial/ml Test 3 - Test 3 - Test 3 -
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Streptococcus sp. Test 2 - Test 2 - Test 2 -
6x10 7
group C 6x107 bacterial/ml
bacterial/ml Test 3 - Test 3 - Test 3 -
#5533240
Test 4 - Test 4 - Test 4 -
Influenza A virus Test 1 - Test 1 - Test 1 -
(H3N2)A/ CEID50 Test 2 - Test 2 - Test 2 -
CEID50 ≥10 per
2.0
Aichi/2/6 ≥103.0 per
0.2 mL Test 3 - Test 3 - Test 3 -
8 0.2 mL
# 62042221 Test 4 - Test 4 - Test 4 -
Part 2:
Product
LOT: LOT: LOT:
COVG2007001-T COVG2007002-T COVG2007003-T
Cross-reactive substance
Original
Name concentration
Final concentration No. Results No. Results No. Results
Adenovirus (e.g. Test 1 - Test 1 - Test 1 -
C1 Ad. Test 2 - Test 2 - Test 2 -
71)-Type 7A 1.41x105 U/ml 2.01x104 U/ml
REF:0810021CFHI Test 3 - Test 3 - Test 3 -
#318404 Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Enterovirus (e.g.
EV68) 5.01x105 7.16x104 Test 2 - Test 2 - Test 2 -
REF: 0810237CFHI TCID50/ml TCID50/ml Test 3 - Test 3 - Test 3 -
#324697
Test 4 - Test 4 - Test 4 -
Human Test 1 - Test 1 - Test 1 -
Metapneumovirus Test 2 - Test 2 - Test 2 -
3.80x10 6
5.43x105
(hMPV)
TCID50/ml TCID50/ml Test 3 - Test 3 - Test 3 -
REF:0810161CFHI
#324683 Test 4 - Test 4 - Test 4 -
Influenza A H1N1 Test 1 - Test 1 - Test 1 -
(New Test 2 - Test 2 - Test 2 -
Cal/20/99) 1.15x107 U/ml 1.64x106 U/ml
REF:0810036CFHI Test 3 - Test 3 - Test 3 -
#320943 Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Influenza B
(Florida/02/06) Test 2 - Test 2 - Test 2 -
1.41x105 U/ml 2.01x104 U/ml
REF:0810037CFHI Test 3 - Test 3 - Test 3 -
#321496
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Parainfluenza
virus 1 9.12x10 8
1.30x108 Test 2 - Test 2 - Test 2 -
REF:0810014CFHI TCID50/ml TCID50/ml Test 3 - Test 3 - Test 3 -
#323599
Test 4 - Test 4 - Test 4 -
16 SURESCREEN DIAGNOSTICSLOT: LOT: LOT:
SURESCREEN DIAGNOSTICS
COVG2007001-T COVG2007002-T COVG2007003-T
Cross-reactive substance
Original
Name concentration
Final concentration No. Results No. Results No. Results
Test 1 - Test 1 - Test 1 -
Parainfluenza
virus 2 Test 2 - Test 2 - Test 2 -
1.15x107 U/ml 1.64x106 U/ml
REF:0810015CFHI Test 3 - Test 3 - Test 3 -
#318974
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Parainfluenza
virus 3 6.61x106 U/ Test 2 - Test 2 - Test 2 -
9.44x105 U/ml
REF:0810016CFHI ml Test 3 - Test 3 - Test 3 -
#317164
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Parainfluenza
virus 4 2.82x10 U/
7 Test 2 - Test 2 - Test 2 -
4.03x106 U/ml
REF:0810060CFHI ml Test 3 - Test 3 - Test 3 -
#314951
Test 4 - Test 4 - Test 4 -
Respiratory Test 1 - Test 1 - Test 1 -
syncytial virus - 3.80x10 U/
6 Test 2 - Test 2 - Test 2 -
Type A 5.43x105 U/ml
REF:0810040ACFHI ml Test 3 - Test 3 - Test 3 -
#320931
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Rhinovirus (Type 1A) 3.55x10 U/
5 Test 2 - Test 2 - Test 2 -
REF:0810012CFNHI 5.07x104 U/ml
#314953 ml Test 3 - Test 3 - Test 3 -
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Bordetella pertussis 1.13x10 10 Test 2 - Test 2 - Test 2 -
REF:0801459 1.61x109 CFU/ml
#323978 CFU/ml Test 3 - Test 3 - Test 3 -
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Candida albicans 6.27x108 Test 2 - Test 2 - Test 2 -
REF:0801504 8.96x107 CFU/ml
#322849 CFU/ml Test 3 - Test 3 - Test 3 -
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Haemophilus
influenzae 5.43x10 8 Test 2 - Test 2 - Test 2 -
REF:0801679
7.76x107 CFU/ml
CFU/ml Test 3 - Test 3 - Test 3 -
#324274
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Legionella
pneumophila 1.88x1010 Test 2 - Test 2 - Test 2 -
REF:0801645
2.69x109 CFU/ml
CFU/ml Test 3 - Test 3 - Test 3 -
#323903
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Mycobacterium
tuberculosis 6.86x10 7 Test 2 - Test 2 - Test 2 -
REF:0801660
9.80x106 CFU/ml
CFU/ml Test 3 - Test 3 - Test 3 -
#323674
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Mycoplasma
pneumoniae 3.16x10 8
4.51x107 Test 2 - Test 2 - Test 2 -
REF:0801579 CCU/ml CCU/ml Test 3 - Test 3 - Test 3 -
#324216
Test 4 - Test 4 - Test 4 -
17 SURESCREEN DIAGNOSTICSLOT: LOT: LOT:
SURESCREEN DIAGNOSTICS
COVG2007001-T COVG2007002-T COVG2007003-T
Cross-reactive substance
Original
Name concentration
Final concentration No. Results No. Results No. Results
Pneumocystis Test 1 - Test 1 - Test 1 -
jirovecii Test 2 - Test 2 - Test 2 -
(PJP)-S. cerevisiae 3.45x108
4.93x107 CFU/ml Test 3 - Test 3 - Test 3 -
Recombinant CFU/ml
REF:0801698
Test 4 - Test 4 - Test 4 -
#324458
Test 1 - Test 1 - Test 1 -
Pseudomonas
aeruginosa 8.44x10 9 Test 2 - Test 2 - Test 2 -
1.21x109 CFU/ml
REF:0801519 CFU/ml Test 3 - Test 3 - Test 3 -
#324065
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Staphylococcus
epidermis 1.21x1010 Test 2 - Test 2 - Test 2 -
REF:0801651
1.73x109 CFU/ml
CFU/ml Test 3 - Test 3 - Test 3 -
#321539
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Streptococcus
pneumoniae 2.26x109 Test 2 - Test 2 - Test 2 -
3.23x108 CFU/ml
REF:0801439 CFU/ml Test 3 - Test 3 - Test 3 -
#322145
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Streptococcus
pyogenes 1.64x10 9 Test 2 - Test 2 - Test 2 -
2.34x108 CFU/ml
REF:0801512 CFU/ml Test 3 - Test 3 - Test 3 -
#324297
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Streptococcus
salivarius 8.17x108 Test 2 - Test 2 - Test 2 -
1.17x108 CFU/ml
REF:0801896 CFU/ml Test 3 - Test 3 - Test 3 -
#323987
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Human
coronavirus 229E 4.17x10 5
5.96x10 4 Test 2 - Test 2 - Test 2 -
REF:0810229CFHI TCID50/ml TCID50/ml Test 3 - Test 3 - Test 3 -
#324451
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Human
coronavirus OC43 1.05x106 1.50x105 Test 2 - Test 2 - Test 2 -
REF:0810024CFHI TCID50/ml TCID50/ml Test 3 - Test 3 - Test 3 -
#324450
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
Human
coronavirus NL63 1.70x10 5
2.43x10 4 Test 2 - Test 2 - Test 2 -
REF:0810228CFHI TCID50/ml TCID50/ml Test 3 - Test 3 - Test 3 -
#324352
Test 4 - Test 4 - Test 4 -
Test 1 - Test 1 - Test 1 -
MERS-coronavirus Test 2 - Test 2 - Test 2 -
3.16x106
4.51x105
REF:0810575CFHI
TCID50/ml TCID50/ml Test 3 - Test 3 - Test 3 -
#324490
Test 4 - Test 4 - Test 4 -
Note: “-“mean negative result.
Conclusion
Three batches of tests did not show the effects of selected cross-substances (≥105CEID/ml, TCID50/ml,
CFU/ml, CCU/ml or U/ml) on negative results.
18 SURESCREEN DIAGNOSTICSSURESCREEN DIAGNOSTICS
3.4. Dose Hook
Material
Product ICOVG-C81
COVG2007001-T, Exp:2022-04
COVG2007002-T, Exp:2022-04
COVG2007003-T, Exp:2022-04
Recombinant Antigen (Nucleocapsid (N) protein): Lot: 20201310-200323, Conc.1.63mg/ml
Positive substance: ZeptoMetrix SARS-COV-2 0810587CFHI; #324916; Conc: 1.15x107TCID50/ml
Method
1. Dilute the Nucleocapsid(N) protein of SARS-CoV-2, add approx.80µLto the sample well in replicates of
three and then start the timer.
2.The inactivated virus culture medium was gradient diluted with buffer solution. The dilution of each
concentration was repeated for 5 Tests, add approx. 80µLto the sample well and then start the timer.
3.Read the result at 10 minutes. Do not interpret the result after 20 minutes. Results were presented in
Table below.
Result
1. Recombinant antigen
Table: Dose Hook
Lot#: COVG2007001-T COVG2007002-T COVG2007003-T
Original Conc.
+ + + + + + + + +
1.63mg/ml
1mg/ml + + + + + + + + +
500ug/ml + + + + + + + + +
100ug/ml + + + + + + + + +
9000ng/ml + + + + + + + + +
5000ng/ml + + + + + + + + +
2000ng/ml + + + + + + + + +
1000ng/ml + + + + + + + + +
600ng/ml + + + + + + + + +
300ng/ml + + + + + + + + +
100ng/ml + + + + + + + + +
60ng/ml + + + + + + + + +
Note: “+” means positive result.
“-” meansnegative result.
19 SURESCREEN DIAGNOSTICSSURESCREEN DIAGNOSTICS
2. Positive substance
No. Conc. COVG2007001-T COVG2007002-T COVG2007003-T
1.0x105
1 + + + + + + + + +
TCID50/ml
5.0x104
2 + + + + + + + + +
TCID50/ml
2.5x104
3 + + + + + + + + +
TCID50/ml
1.25x104
4 + + + + + + + + +
TCID50/ml
6.25x103
5 + + + + + + + + +
TCID50/ml
3.0x103
6 + + + + + + + + +
TCID50/ml
2.0x103
7 + + + + + + + + +
TCID50/ml
1.5x103
8 + + + + + + + + +
TCID50/mll
1.25x103
9 + + + + + + + + +
TCID50/ml
1.0x103
10 + + + + + + + + +
TCID50/ml
7.5x102
11 - - - - - - - - -
TCID50/ml
5.0x102
12 - - - - - - - - -
TCID50/ml
2.5x102
13 - - - - - - - - -
TCID50/ml
1.25x102
14 - - - - - - - - -
TCID50/ml
Conclusion:
Test results showed that there was no Dose Hook effect of the 3 lots of COVID-19 Antigen Rapid Test
Cassette (Saliva/Nasopharyngeal Swab) products. There is no dose hook effect when the concentration
of SARS-CoV-2 recombinant antigen is lower than 1.63mg/ml, and the concentration of positive substance
is lower than 1.0x105TCID50/mL.
20 SURESCREEN DIAGNOSTICSSURESCREEN DIAGNOSTICS
3.5. Detection Limit
Purpose
Test the detection limit of COVID-19 Antigen Rapid Test Cassette (Saliva/Nasopharyngeal Swab)
product by diluting antigen and inactivated virus culture medium.
Material
Product ICOVG-C81
COVG2007001-T, Exp:2022-04
COVG2007002-T, Exp:2022-04
COVG2007003-T, Exp:2022-04
Recombinant Antigen (Nucleocapsid (N) protein): Lot: 20201310-200323 Conc.1.63mg/ml
Positive substance: ZeptoMetrix SARS-COV-2 0810587CFHI; #324916; Conc: 1.15x107TCID50/ml
Method
1. The high value + standard was gradient diluted with buffer solution. The dilution of each concentration
was repeated for 3 Tests, for a total of 3 batches. Then 20 repeated tests were carried out for the
quality control of the lowest detected concentration limit.
2.The inactivated virus culture medium was gradient diluted with buffer solution. The dilution of each
concentration was repeated for 5 Tests, add approx. 80µL to the sample well and then start the timer.
Add approx. 80µL to the sample well in replicates of three and then start the timer. Read the result at 10
minutes. Do not interpret the result after 20 minutes. Results were presented in Table below.
Result
1. Recombinant Antigen
Product
COVG2007001-T COVG2007002-T COVG2007003-T
Antigen
Concentration
Original Conc.
+ + + + + + + + +
1.63mg/ml
500ug/ml + + + + + + + + +
100ug/ml + + + + + + + + +
500ng/ml + + + + + + + + +
100ug/ml + + + + + + + + +
50ng/ml + + + + + + + + +
10ng/ml + + + + + + + + +
1ng/ml + + + + + + + + +
500pg/ml + + + + + + + + +
200pg/ml + + + + + + + + +
100pg/ml + + + + + + + + +
50pg/ml + + + + + + + + +
25pg/ml - - - - - - - - -
21 SURESCREEN DIAGNOSTICSSURESCREEN DIAGNOSTICS
Minimum detection
No. COVG2007001-T COVG2007002-T COVG2007003-T
limit of Antigen
Test 1 + + +
Test 2 + + +
Test 3 + + +
Test 4 + + +
Test 5 + + +
Test 6 + + +
Test 7 + + +
Test 8 + + +
Test 9 + + +
Test 10 + + +
50pg/ml
Test 11 + + +
Test 12 + + +
Test 13 + + +
Test 14 + + +
Test 15 + + +
Test 16 + + +
Test 17 + + +
Test 18 + + +
Test 19 + + +
Test 20 + + +
2. Positive substance
No. Conc. COVG2007001-T COVG2007002-T COVG2007003-T
1.0x105
1 + + + + + + + + +
TCID50/ml
5.0x104
2 + + + + + + + + +
TCID50/ml
2.5x104
3 + + + + + + + + +
TCID50/ml
1.25x104
4 + + + + + + + + +
TCID50/ml
6.25x103
5 + + + + + + + + +
TCID50/ml
22 SURESCREEN DIAGNOSTICSSURESCREEN DIAGNOSTICS
3.0x103
6 + + + + + + + + +
TCID50/ml
2.0x103
7 + + + + + + + + +
TCID50/ml
1.5x103
8 + + + + + + + + +
TCID50/mll
1.25x103
9 + + + + + + + + +
TCID50/ml
1.0x103
10 + + + + + + + + +
TCID50/ml
7.5x102
11 - - - - - - - - -
TCID50/ml
5.0x102
12 - - - - - - - - -
TCID50/ml
2.5x102
13 - - - - - - - - -
TCID50/ml
1.25x102
14 - - - - - - - - -
TCID50/ml
Note: “-”mean negative result “+” mean Positive result
Conclusion
Test results showed that there was no Dose Hook effect of the 3 lots of COVID-19 Antigen Rapid
Test Cassette (Saliva/Nasopharyngeal Swab) products. The minimum detection limit of protein was
50pg/ml. The material (ZeptoMetrix,0810587CFHI) was supplied at a concentration of 1.15 x 107
TCID50/mL. The Estimated LOD is 1000 TCID50/mL.
23 SURESCREEN DIAGNOSTICSSURESCREEN DIAGNOSTICS
3.6. Variability (Inter\Intra\Day to day assay)
Material
INCP-C81: COVG2007001-T, Exp:2022-07
COVG2007002-T, Exp:2022-07
COVG2007003-T, Exp:2022-07
Standard sample:
Negative Lot:NCOV200406-01N-T
SARS-CoV-2 Low sample (COVG L) Lot:NCOV200406-02N-T
SARS-CoV-2 High sample (COVG H) Lot:NCOV200406-03N-T
Method
Add approx. 80µL of the SARS-CoV-2 negative, SARS-CoV-2 Low sample, or SARS-CoV-2 High
sample to sample well and then start the timer. Read the result at 10 minutes. Five replicates of each level
were tested each day for 3 consecutive days using all the 3 lots. Read the results at 10 minutes. Results
were presented in Table below.
Result
Table: Variability
Negative
Day Lot#: 1 2 3 4 5
COVG2007001-T - - - - -
Day 1 COVG2007002-T - - - - -
COVG2007003-T - - - - -
COVG2007001-T - - - - -
Day 2 COVG2007002-T - - - - -
COVG2007003-T - - - - -
COVG2007001-T - - - - -
Day 3 COVG2007002-T - - - - -
COVG2007003-T - - - - -
SARS-CoV-2 High positive
Day Lot#: 1 2 3 4 5
COVG2007001-T + + + + +
Day 1 COVG2007002-T + + + + +
COVG2007003-T + + + + +
COVG2007001-T + + + + +
Day 2 COVG2007002-T + + + + +
COVG2007003-T + + + + +
COVG2007001-T + + + + +
Day 3 COVG2007002-T + + + + +
COVG2007003-T + + + + +
24 SURESCREEN DIAGNOSTICSSURESCREEN DIAGNOSTICS
SARS-CoV-2 Low positive
Day Lot#: 1 2 3 4 5
COVG2007001-T + + + + +
Day 1 COVG2007002-T + + + + +
COVG2007003-T + + + + +
COVG2007001-T + + + + +
Day 2 COVG2007002-T + + + + +
COVG2007003-T + + + + +
COVG2007001-T + + + + +
Day 3 COVG2007002-T + + + + +
COVG2007003-T + + + + +
Note: “-”means negative result,
“+” means positive result.
Conclusion
The tables above show that different lots of COVID-19 Antigen Rapid Test Cassette(Saliva/
Nasopharyngeal Swab) products have similar results, and they also give a similar performance day to
day.
25 SURESCREEN DIAGNOSTICSSURESCREEN DIAGNOSTICS
3.7. Accelerated Stability
Material
INCP-C81: COVG2007001-T, Exp:2022-07
COVG2007002-T, Exp:2022-07
COVG2007003-T, Exp:2022-07
Standard
Negative Lot:NCOV200406-01N-T
SARS-CoV-2 Low sample (COVG L) Lot:NCOV200406-02N-T
SARS-CoV-2 High sample (COVG H) Lot:NCOV200406-03N-T
Method
Accelerated Stability of the COVID-19 Antigen Rapid Test Cassette (Saliva/Nasopharyngeal
Swab) was evaluated using samples from three different batches. These were placed in an incubator
with the temperature calibrated at 45°C and 55°C. Relative humidity (RH) calibrated at about 60%.
A series of stability tests were performed at 45°C and 55°C according to Arrhenius Plot. See Table
below. Tests were assessed using negative, COVG High positive (COVG H), and COVG Low positive
(COVG L) samples. Testing at each specific time interval consisted of 3 replicates for each specimen. The
tests were performed according to the package insert. Results are presented in Table below.
Arrhenius Formula:
In K=-Ea/RT + In A
“K” means Rate constant
“A” means Arrhenius constant
“Ea” means Activation energy
“R” means Gas constant
“T” means Temperature in Kelvin
Table: Time line for Accelerate Stability Study
Day
0 day 7 days 14 days 21 days 28 days 35 days 42 days 56 days 77 days 84 days
Temp
45°C √ √ √ √ √ √ √ √ √ √
55°C √ √ √ √ √ √ √ / / /
Standard sample:
Negative Lot:NCOV200406-01N-T
SARS-CoV-2 Low sample(COVG L) Lot:NCOV200406-02N-T
SARS-CoV-2 High sample (COVG H) Lot:NCOV200406-03N-T
26 SURESCREEN DIAGNOSTICSSURESCREEN DIAGNOSTICS
Results
Table: 45°C Accelerated Stability Summar
COVG2007001-T COVG2007002-T COVG2007003-T
- - - - - - - - -
- - - - - - - - -
Negative
- - - - - - - - -
- N/A N/A - N/A N/A - N/A N/A
+ + + + + + + + +
+ + + + + + + + +
0 COVG H
+ + + + + + + + +
+ N/A N/A + N/A N/A + N/A N/A
+ + + + + + + + +
+ + + + + + + + +
COVG L
+ + + + + + + + +
+ N/A N/A + N/A N/A + N/A N/A
Negative - - - - - - - - -
7 COVG H + + + + + + + + +
COVG L + + + + + + + + +
Negative - - - - - - - - -
14 COVG H + + + + + + + + +
COVG L + + + + + + + + +
Negative - - - - - - - - -
21 COVG H + + + + + + + + +
COVG L + + + + + + + + +
Negative - - - - - - - - -
28 COVG H + + + + + + + + +
COVG L + + + + + + + + +
Negative - - - - - - - - -
35 COVG H + + + + + + + + +
COVG L + + + + + + + + +
Negative - - - - - - - - -
42 COVG H + + + + + + + + +
COVG L + + + + + + + + +
Negative - - - - - - - - -
56 COVG H + + + + + + + + +
COVG L + + + + + + + + +
Negative - - - - - - - - -
77 COVG H + + + + + + + + +
COVG L + + + + + + + + +
Negative - - - - - - - - -
84 COVG H + + + + + + + + +
COVG L + + + + + + + + +
27 SURESCREEN DIAGNOSTICSSURESCREEN DIAGNOSTICS
Table: 55°C Accelerated Stability Summary
COVG2007001-T COVG2007002-T COVG2007003-T
- - - - - - - - -
- - - - - - - - -
Negative
- - - - - - - - -
- N/A N/A - N/A N/A - N/A N/A
+ + + + + + + + +
+ + + + + + + + +
0 COVG H
+ + + + + + + + +
+ N/A N/A + N/A N/A + N/A N/A
+ + + + + + + + +
+ + + + + + + + +
COVG L
+ + + + + + + + +
+ N/A N/A + N/A N/A + N/A N/A
Negative - - - - - - - - -
7 COVG H + + + + + + + + +
COVG L + + + + + + + + +
Negative - - - - - - - - -
14 COVG H + + + + + + + + +
COVG L + + + + + + + + +
Negative - - - - - - - - -
21 COVG H + + + + + + + + +
COVG L + + + + + + + + +
Negative - - - - - - - - -
28 COVG H + + + + + + + + +
COVG L + + + + + + + + +
Negative - - - - - - - - -
35 COVG H + + + + + + + + +
COVG L + + + + + + + + +
Negative - - - - - - - - -
42 COVG H + + + + + + + + +
COVG L + + + + + + + + +
Note: “-”means negative result, “+” means positive result.
Conclusion
The COVID-19 Antigen Rapid Test Cassette (Saliva/Nasopharyngeal Swab) is stable at 45°C for 84 days
and 55°C for 42 days. This data was plotted on an Arrhenius Plot and the shelf life of this product was
determined to be at least 24 months from the date of manufacture.
28 SURESCREEN DIAGNOSTICSinfo@surescreen.com +44 (0)1332 365318 surescreen.com SureScreen Diagnostics, 1 Prime Parkway, Prime Enterprise Park, Derby, DE1 3QB
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