camtech covid-19 igm/igg - keli devices · camtech diagnostics pte ltd 217 henderson road, #04-08,...
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Camtech-COVID-19-IgG_IgM-Insert-EN_v9_withLancet.pdf.pdfCamtech
Diagnostics Pte Ltd 217 Henderson Road, #04-08, Henderson
Industrial Park, 159555, SINGAPORE www.camtech.org
INTENDED USE Camtech COVID-19 IgM/IgG device is a chromatographic immunoassay kit for the rapid and differential detection of immunoglobulin M (lgM) and immunoglobulin G (IgG) against COVID-19 using serum, plasma and whole blood. The results from this test is not to be used for confirmatory testing or as sole basis for diagnosis. The results will have to be interpreted together with clinical presentation and are to be confirmed with supplemental testing (e.g. RT-PCR). Camtech COVID-19 IgM/IgG has received Provisional Authorisation from the Health Sciences Authority in Singapore.
SUMMARY Early January 2020, a novel coronavirus (2019-nCoV) was identified as the infectious agent causing an outbreak of viral pneumonia in Wuhan, China, where the first cases had their symptom onset in December 2019.1 Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds and that cause respiratory, enteric, hepatic, and neurologic diseases.2 Six coronavirus species are known to cause human disease.3 Four viruses — 229E, OC43, NL63, and HKU1 — are prevalent and typically cause common cold symptoms in immunocompetent individuals.3 The two other strains — severe acute respiratory syndrome coronavirus (SARS- COV) and Middle East respiratory syndrome coronavirus (MERS-COV) — are zoonotic in origin and have been linked to sometimes fatal illness.4 Coronaviruses are zoonotic, meaning they are transmitted between animals and people. Common signs of infection include respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and even death.5 Standard recommendations to prevent infection spread include regular hand washing, covering mouth and nose when coughing and sneezing, thoroughly cooking meat and eggs. Avoid close contact with anyone showing symptoms of respiratory illness such as coughing and sneezing.5
EXPLANATION OF THE TEST The recombinant COVID-19 antigen was coated on the membrane and anti-human IgM and IgG monoclonal antibody was conjugated with the gold particles, respectively. When the specimen containing existing anti-COVID-19 antibodies is loaded into a sample well (S), the antibodies are complexed with anti-human IgM (or IgG) gold conjugate. This complex then migrates and captured by the immobilized recombinant COVID-19 antigens to make a visible band in the test line regions, M and G. The solution continues to migrate to the control line (C) region that binds a control conjugate, thereby producing another red line. The Camtech COVID-19 IgM/IgG test can therefore detect the antibodies against COVID-19.
MATERIALS PROVIDED The Camtech COVID-19 IgM/IgG kit contains the following components:
1. Test device individually foil-pouched with a desiccant 2. Assay solution in dropping bottle 3. Capillary tube for sample loading 4. Instructions for Use
MATERIALS REQUIRED BUT NOT PROVIDED 1. Specimen collection container 2. Micropipette 3. Disposable pipette tips 4. Lancets (for finger prick whole blood only) 5. Centrifuge (for plasma only) 6. Watch or timer
PRECAUTIONS 1. The presence of humidity may decrease the stability of the reagents. Thus, please carry
out the test immediately after removing the device from the foil pouch. 2. Do not use the kit after the expiration date. Do not freeze the kit. 3. Do not re-use the test device. 4. Wear protective gloves while handling samples and wash hands thoroughly after the test. 5. Dispose gloves, swabs, test tubes, and the used strips properly after the test, in
accordance with GLP. 6. Do not eat or smoke while handing specimens. 7. Decontaminate and dispose of all specimens, in a biohazard container.
SPECIMEN COLLECTION AND STORAGE 1. Specimen to be tested should be obtained and handled by standard collection methods. 2. Serum: Allow the blood to clot, then centrifuge to separate the serum. 3. Plasma: Collect the whole blood into the tube containing anticoagulants such as heparin,
citrate, or EDTA. Centrifuge the blood and separate the plasma. 4. Whole blood: whole blood should be collected over heparin, citrate, or EDTA. Mix the blood
by inversion and use it for the test. If fingertip blood is used to the test, prick the finger and collect the blood by a capillary tube, and then load the blood onto the sample well (S) of the test device.
5. All specimens should be tested as soon as early they are prepared. If necessary, they may be stored at 2-8°C for up to 24 hours or at -20°C for longer periods.
TEST PROCEDURE 1. Place all specimens, test devices, and assay solution at room temperature prior to testing
(15-30min). 2. [Capillary tube use] Using the capillary tube, add 10 μl of serum/plasma or load 20 μl of
whole blood up to the black line and then into the sample well (S). [Micropipette use] Add 10 μl of serum/plasma or load 20 μl of whole blood into the sample well (S) directly. Add 3 drops (approx. 100 μl) of assay solution into the buffer well (S) in the device.
3. After 10 minutes, interpret the test results. Please do not read the results after 10 minutes of this testing.
INTERPRETATION OF THE RESULTS 1. Negative: ONLY one band in the control line (C). No COVID-19-specific IgM and IgG were
detected. Re-test in 3-5 days if COVID-19 is suspected. 2. IgM Positive: two bands appear in the test line (T) and control line (C) in the left side of the
device. 3. IgG Positive: two bands appear in the test line (T) and control line (C) in the right side of
the device. 4. IgG and IgM Positive: each two bands appear in the test line (T) and control line (C) in both
sides of the device. 5. Invalid result: If at 10 minutes, the red band does not appear in the control line (C), the
result is considered invalid. If the test is invalid, a new test should be performed with a new patient specimen and a new test device.
CAMTECH COVID-19 IgM/IgG
Add 10 of serum/plasma or load 20 of whole blood
10 min Reading Add 3 drops (~100 )
of assay buffer
Camtech Diagnostics Pte Ltd 217 Henderson Road, #04-08, Henderson Industrial Park, 159555, SINGAPORE www.camtech.org
CLINICAL PERFORMANCE DATA
For IgM / IgG
Before Day 3 from symptoms After Day 7 from symptoms
Positive Negative Positive Negative
Positive 3 1 30 1
Negative 6 119 0 119
Total 9 120 30 120
Sensitivity (Before Day 3/After Day 7) = 30% (3/9) / > 90% (25/30) Specificity > 95%
Camtech Covid-19 IgM/IgG rapid test has an overall sensitivity >90% and an overall specificity >95% when being compared to RT-PCR.
STORAGE & EXPIRATION 1. Camtech COVID-19 IgM/IgG kit should be stored between 2 to 30 °C (35.6 to 86 °F). 2. Expiration date of this kit is 6 months after its manufacturing date.
LIMITATIONS OF THE TEST The product has not been tested with samples positive for other coronavirus antibodies. This test detects the presence of COVID-19 antibodies (IgM/IgG) in blood samples. As there may be a few days’ delay between the viral infection and development of antibodies in an individual, any negative result from this test should not be used as sole basis to rule out COVID-19 infection. The negative results have to be carefully considered together with clinical presentations. Any positive result from this test should be confirmed with supplemental laboratory testing (e.g. RT- PCR).
REFERENCES 1. World Health Organization(WHO). WHO Statement Regarding Cluster of Pneumonia Cases in Wuhan, China. Beijing: WHO; 9 Jan 2020. [Accessed 26 Jan 2020]. https://www.who.int/china/news/detail/09-01-2020-who-statement-regarding-cluster-of- pneumonia-cases-in-wuhan-china 2. WeissSR, LeibowitzJL. Coronavirus pathogenesis. Adv Virus Res 2011;81:85-164. PMID: 22094080 DOI:10.1016/B978-0-12-385885-6.00009-2 3. Su 8, Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. Trends Microbiol 2016;24:490-502. PMID:27012512 DOI:10.1016/j.tim.2016.03.003 4. Cui J, Li F, Shi ZL. Origin and evolution of pathogenic coronaviruses. Nat Rev Microbiol 2019;17:181-192. PMID:30531947 DOI:10.1038/s41579-018-0118-9 5. World Health Organization (WHO).Coronavirus. https://www.who.int/health-topics/coronavirus
CAMTECH COVID-19 IgM/IgG
covid19-test.com
About COVID-19
The coronavirus outbreak has swept across the Globe evolving into a pandemic as
declared by the WHO on the 12 March 2020. Diagnosis has been at the forefront of
monitoring the spread of the disease and ensuring timely treatment, especially, for
those who are most at risk.
The currently employed method for diagnosis relies on RT-PCR to identify
viral-specific nucleotides. Although accurate, this approach is both time and labour
intensive, moreover, requiring specialist training and equipment. Therefore, there
is a need for an easy to use, rapid testing approach to provide timely treatment
and identification of post-infection immunity in mind or asymptomatic cases.
FAST z RELIABLE z ACCURATE
IgG and IgM in whole blood, serum and plasma
Results in less than 20 minutes including sample preparation
High sensivity & specificity
Only two drops of blood needed
Received provisional authorisa- tion from the Health Sciences Authority (HSA) in Singapore
Manufactured under ISO 13485
COMPARISON WITH MOLECULAR TESTING
ASSAY PROCEDURE & INTERPRETATION
Add 10 µl of serum / plasma or load 20 µl of whole blood
COVID-19 IgM
COVID-19 IgG
COVID-19 IgM
COVID-19 IgG
COVID-19 IgM
COVID-19 IgG
COVID-19 IgM
COVID-19 IgG
COVID-19 IgM
COVID-19 IgG
COVID-19 IgM
COVID-19 IgG
Limitations and precautions
1. The test kit is intended to be used by a medical professional.
2. This test detects the presence of COVID-19 antibodies (IgM/IgG) in blood samples. As there may be a few days’ delay between the viral infection and development of antibodies in an individual, any negative result from this test should not be used as sole basis to rule out COVID-19 infection. The negative results have to be carefully considered together with clinical presentations. Any positive result from this test should be confirmed with supplemental laboratory testing (e.g. RT-PCR).
3. Dispose gloves, swabs, test tubes, and the used strips properly after the test, in accordance with GLP.
4. Do not use the kit after the expiration date or more than 30 minutes after removing it from the sealed package. Do not re-use the test device.
5. The kit should be stored between 2°C to 30°C (36°F to 86°F).
MOLECULAR TESTING (RT-PCR)
Test cost
Accuracy (field data) - China: 30-50% (Jungangilbo 2020.02.13.) - Depending on the swab positioning of the specimen and yield of gene extraction
- Before Day 5: very low - After Day 5: 81-99% for IgM, 81-99% for IgG
Nucleic acid test of SARS-CoV-2
> 2 hours
Very expensive
Trained personnel
Throat, nasopharyngeal swab, sputum
- Accurate at early stage - Difficult to detect latent stages of infection or post-infection. - Appropriate for early stage with limited cases of patients up to 100 patient load
20 minutes
Highly economical
Untrained personnel
Sensitivity
Specificity
Day 3 after symptoms: IgM - 30%; IgG - 0% After Day 7 from symptoms: IgM 80%; IgG >95%
IgM 98% (118/120); IgG 99% (119/120)
with limited cases
- Possible to detect latent stages of infection or post-infection. - Appropriate 5 days after the onset of symptoms - Suitable for testing a large number of patients
Antibody IgM/IgG detection in blood
COVID-19 IgM/IgG RAPID SCREENING TEST
DIAGNOSTIC ACCURACY
PERFORMANCE (ONGOING)PARAMETERS
Analytical sensitivity 1.84 s/CO for IgM; 1.57 s/CO for IgG with ELISA
COMMENTS
CARTON SIZE (mm)
Camtech Diagnostics Pte Ltd
+65 6273 9707
www.camtech.org camtech diagnostics
INTENDED USE Camtech COVID-19 IgM/IgG device is a chromatographic immunoassay kit for the rapid and differential detection of immunoglobulin M (lgM) and immunoglobulin G (IgG) against COVID-19 using serum, plasma and whole blood. The results from this test is not to be used for confirmatory testing or as sole basis for diagnosis. The results will have to be interpreted together with clinical presentation and are to be confirmed with supplemental testing (e.g. RT-PCR). Camtech COVID-19 IgM/IgG has received Provisional Authorisation from the Health Sciences Authority in Singapore.
SUMMARY Early January 2020, a novel coronavirus (2019-nCoV) was identified as the infectious agent causing an outbreak of viral pneumonia in Wuhan, China, where the first cases had their symptom onset in December 2019.1 Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds and that cause respiratory, enteric, hepatic, and neurologic diseases.2 Six coronavirus species are known to cause human disease.3 Four viruses — 229E, OC43, NL63, and HKU1 — are prevalent and typically cause common cold symptoms in immunocompetent individuals.3 The two other strains — severe acute respiratory syndrome coronavirus (SARS- COV) and Middle East respiratory syndrome coronavirus (MERS-COV) — are zoonotic in origin and have been linked to sometimes fatal illness.4 Coronaviruses are zoonotic, meaning they are transmitted between animals and people. Common signs of infection include respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and even death.5 Standard recommendations to prevent infection spread include regular hand washing, covering mouth and nose when coughing and sneezing, thoroughly cooking meat and eggs. Avoid close contact with anyone showing symptoms of respiratory illness such as coughing and sneezing.5
EXPLANATION OF THE TEST The recombinant COVID-19 antigen was coated on the membrane and anti-human IgM and IgG monoclonal antibody was conjugated with the gold particles, respectively. When the specimen containing existing anti-COVID-19 antibodies is loaded into a sample well (S), the antibodies are complexed with anti-human IgM (or IgG) gold conjugate. This complex then migrates and captured by the immobilized recombinant COVID-19 antigens to make a visible band in the test line regions, M and G. The solution continues to migrate to the control line (C) region that binds a control conjugate, thereby producing another red line. The Camtech COVID-19 IgM/IgG test can therefore detect the antibodies against COVID-19.
MATERIALS PROVIDED The Camtech COVID-19 IgM/IgG kit contains the following components:
1. Test device individually foil-pouched with a desiccant 2. Assay solution in dropping bottle 3. Capillary tube for sample loading 4. Instructions for Use
MATERIALS REQUIRED BUT NOT PROVIDED 1. Specimen collection container 2. Micropipette 3. Disposable pipette tips 4. Lancets (for finger prick whole blood only) 5. Centrifuge (for plasma only) 6. Watch or timer
PRECAUTIONS 1. The presence of humidity may decrease the stability of the reagents. Thus, please carry
out the test immediately after removing the device from the foil pouch. 2. Do not use the kit after the expiration date. Do not freeze the kit. 3. Do not re-use the test device. 4. Wear protective gloves while handling samples and wash hands thoroughly after the test. 5. Dispose gloves, swabs, test tubes, and the used strips properly after the test, in
accordance with GLP. 6. Do not eat or smoke while handing specimens. 7. Decontaminate and dispose of all specimens, in a biohazard container.
SPECIMEN COLLECTION AND STORAGE 1. Specimen to be tested should be obtained and handled by standard collection methods. 2. Serum: Allow the blood to clot, then centrifuge to separate the serum. 3. Plasma: Collect the whole blood into the tube containing anticoagulants such as heparin,
citrate, or EDTA. Centrifuge the blood and separate the plasma. 4. Whole blood: whole blood should be collected over heparin, citrate, or EDTA. Mix the blood
by inversion and use it for the test. If fingertip blood is used to the test, prick the finger and collect the blood by a capillary tube, and then load the blood onto the sample well (S) of the test device.
5. All specimens should be tested as soon as early they are prepared. If necessary, they may be stored at 2-8°C for up to 24 hours or at -20°C for longer periods.
TEST PROCEDURE 1. Place all specimens, test devices, and assay solution at room temperature prior to testing
(15-30min). 2. [Capillary tube use] Using the capillary tube, add 10 μl of serum/plasma or load 20 μl of
whole blood up to the black line and then into the sample well (S). [Micropipette use] Add 10 μl of serum/plasma or load 20 μl of whole blood into the sample well (S) directly. Add 3 drops (approx. 100 μl) of assay solution into the buffer well (S) in the device.
3. After 10 minutes, interpret the test results. Please do not read the results after 10 minutes of this testing.
INTERPRETATION OF THE RESULTS 1. Negative: ONLY one band in the control line (C). No COVID-19-specific IgM and IgG were
detected. Re-test in 3-5 days if COVID-19 is suspected. 2. IgM Positive: two bands appear in the test line (T) and control line (C) in the left side of the
device. 3. IgG Positive: two bands appear in the test line (T) and control line (C) in the right side of
the device. 4. IgG and IgM Positive: each two bands appear in the test line (T) and control line (C) in both
sides of the device. 5. Invalid result: If at 10 minutes, the red band does not appear in the control line (C), the
result is considered invalid. If the test is invalid, a new test should be performed with a new patient specimen and a new test device.
CAMTECH COVID-19 IgM/IgG
Add 10 of serum/plasma or load 20 of whole blood
10 min Reading Add 3 drops (~100 )
of assay buffer
Camtech Diagnostics Pte Ltd 217 Henderson Road, #04-08, Henderson Industrial Park, 159555, SINGAPORE www.camtech.org
CLINICAL PERFORMANCE DATA
For IgM / IgG
Before Day 3 from symptoms After Day 7 from symptoms
Positive Negative Positive Negative
Positive 3 1 30 1
Negative 6 119 0 119
Total 9 120 30 120
Sensitivity (Before Day 3/After Day 7) = 30% (3/9) / > 90% (25/30) Specificity > 95%
Camtech Covid-19 IgM/IgG rapid test has an overall sensitivity >90% and an overall specificity >95% when being compared to RT-PCR.
STORAGE & EXPIRATION 1. Camtech COVID-19 IgM/IgG kit should be stored between 2 to 30 °C (35.6 to 86 °F). 2. Expiration date of this kit is 6 months after its manufacturing date.
LIMITATIONS OF THE TEST The product has not been tested with samples positive for other coronavirus antibodies. This test detects the presence of COVID-19 antibodies (IgM/IgG) in blood samples. As there may be a few days’ delay between the viral infection and development of antibodies in an individual, any negative result from this test should not be used as sole basis to rule out COVID-19 infection. The negative results have to be carefully considered together with clinical presentations. Any positive result from this test should be confirmed with supplemental laboratory testing (e.g. RT- PCR).
REFERENCES 1. World Health Organization(WHO). WHO Statement Regarding Cluster of Pneumonia Cases in Wuhan, China. Beijing: WHO; 9 Jan 2020. [Accessed 26 Jan 2020]. https://www.who.int/china/news/detail/09-01-2020-who-statement-regarding-cluster-of- pneumonia-cases-in-wuhan-china 2. WeissSR, LeibowitzJL. Coronavirus pathogenesis. Adv Virus Res 2011;81:85-164. PMID: 22094080 DOI:10.1016/B978-0-12-385885-6.00009-2 3. Su 8, Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. Trends Microbiol 2016;24:490-502. PMID:27012512 DOI:10.1016/j.tim.2016.03.003 4. Cui J, Li F, Shi ZL. Origin and evolution of pathogenic coronaviruses. Nat Rev Microbiol 2019;17:181-192. PMID:30531947 DOI:10.1038/s41579-018-0118-9 5. World Health Organization (WHO).Coronavirus. https://www.who.int/health-topics/coronavirus
CAMTECH COVID-19 IgM/IgG
covid19-test.com
About COVID-19
The coronavirus outbreak has swept across the Globe evolving into a pandemic as
declared by the WHO on the 12 March 2020. Diagnosis has been at the forefront of
monitoring the spread of the disease and ensuring timely treatment, especially, for
those who are most at risk.
The currently employed method for diagnosis relies on RT-PCR to identify
viral-specific nucleotides. Although accurate, this approach is both time and labour
intensive, moreover, requiring specialist training and equipment. Therefore, there
is a need for an easy to use, rapid testing approach to provide timely treatment
and identification of post-infection immunity in mind or asymptomatic cases.
FAST z RELIABLE z ACCURATE
IgG and IgM in whole blood, serum and plasma
Results in less than 20 minutes including sample preparation
High sensivity & specificity
Only two drops of blood needed
Received provisional authorisa- tion from the Health Sciences Authority (HSA) in Singapore
Manufactured under ISO 13485
COMPARISON WITH MOLECULAR TESTING
ASSAY PROCEDURE & INTERPRETATION
Add 10 µl of serum / plasma or load 20 µl of whole blood
COVID-19 IgM
COVID-19 IgG
COVID-19 IgM
COVID-19 IgG
COVID-19 IgM
COVID-19 IgG
COVID-19 IgM
COVID-19 IgG
COVID-19 IgM
COVID-19 IgG
COVID-19 IgM
COVID-19 IgG
Limitations and precautions
1. The test kit is intended to be used by a medical professional.
2. This test detects the presence of COVID-19 antibodies (IgM/IgG) in blood samples. As there may be a few days’ delay between the viral infection and development of antibodies in an individual, any negative result from this test should not be used as sole basis to rule out COVID-19 infection. The negative results have to be carefully considered together with clinical presentations. Any positive result from this test should be confirmed with supplemental laboratory testing (e.g. RT-PCR).
3. Dispose gloves, swabs, test tubes, and the used strips properly after the test, in accordance with GLP.
4. Do not use the kit after the expiration date or more than 30 minutes after removing it from the sealed package. Do not re-use the test device.
5. The kit should be stored between 2°C to 30°C (36°F to 86°F).
MOLECULAR TESTING (RT-PCR)
Test cost
Accuracy (field data) - China: 30-50% (Jungangilbo 2020.02.13.) - Depending on the swab positioning of the specimen and yield of gene extraction
- Before Day 5: very low - After Day 5: 81-99% for IgM, 81-99% for IgG
Nucleic acid test of SARS-CoV-2
> 2 hours
Very expensive
Trained personnel
Throat, nasopharyngeal swab, sputum
- Accurate at early stage - Difficult to detect latent stages of infection or post-infection. - Appropriate for early stage with limited cases of patients up to 100 patient load
20 minutes
Highly economical
Untrained personnel
Sensitivity
Specificity
Day 3 after symptoms: IgM - 30%; IgG - 0% After Day 7 from symptoms: IgM 80%; IgG >95%
IgM 98% (118/120); IgG 99% (119/120)
with limited cases
- Possible to detect latent stages of infection or post-infection. - Appropriate 5 days after the onset of symptoms - Suitable for testing a large number of patients
Antibody IgM/IgG detection in blood
COVID-19 IgM/IgG RAPID SCREENING TEST
DIAGNOSTIC ACCURACY
PERFORMANCE (ONGOING)PARAMETERS
Analytical sensitivity 1.84 s/CO for IgM; 1.57 s/CO for IgG with ELISA
COMMENTS
CARTON SIZE (mm)
Camtech Diagnostics Pte Ltd
+65 6273 9707
www.camtech.org camtech diagnostics