COVID-19 IGG/IGM RAPID TEST CASSETTE
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COVID-19 IgG/IgM Rapid Test Cassette
(Whole Blood/Serum/Plasma)
• Test COVID-19 both IgG and IgM Ab
• Rapid result in in 10min.
• Whole blood (Finger prick available), serum and plasma sample
• Easy to use no analyzer required
• Store at room temperature or refrigerator
The COVID-19 The novel 2019 Coronavirus Pneumonia (NCP) or “COVID-19” was confirmed and named by the World Health Organisation (WHO) in January 2020 when it was discov- ered in Wuhan, China. On January 30th 2020 WHO released the new Coronavirus infection pneumonia epidemic as a public emergency of international concern. The pneumonia is caused by the novel coronavirus (SARS-CoV-2) mainly transmitted through respiratory droplets. Typical symptoms of coronavirus include fever and a cough that may progress to a severe pneumonia causing shortness of breath and breathing difficulties. Coronavirus can cause more severe symptoms in people with weakened immune systems, older people, and those with long-term conditions like diabetes, cancer and chronic lung disease. Prestige Diagnostics UK are now offering a COVID-19 IgG/IgM Rapid Test offering high accuracy and quick results. Specificity and Sensitivity Visual result read in 10 min. The COVID-19 Rapid Test Cassette has been compared with a commercial PCR test, the results indicating high specificity and sensitivity: IgG results: Relative Sensitivity: 100% (CI*: 86.0% - 100%) Relative Specificity: 98.0% (95% CI*: 89.4% - 99.9%) Accuracy: 98.6% (95%CI*: 92.3% - 99.96%) IgM results: Relative Sensitivity: 85.0% (95%CI*: 62.1% - 96.8%) Relative Specificity: 96.0% (95% CI*: 86.3% - 99.5%) Accuracy: 92.9% (95% CI*: 84.1% - 97.6%) *Confidence Intervals Cat No. D escription Store Temp. RADCOV1 COVID-19 IgG/IgM Rapid Test Cassette 2 - 30ºC Prestige Diagnostics UK Ltd. Ballymena Business Centre, Galgorm, Co. Antrim, BT42 1FL, United Kingdom Tel: +44 (0) 28 2564 2100 ∣ Email: info@prestigediagnostics.co.uk ∣ Website: www.prestigediagnostics.co.uk
2019-nCoV 抗体 IgG/IgM 快检卡（二合一）
产品规格
产品规格：20 测试/盒
内容：检测卡 x20，一次性吸管 x20，稀
释液 x1，说明书 x1
装箱：65 盒/箱
外箱尺寸：60.5×45.5×37 cm
毛重：10Kg
保存温度：2-30ºC
有效期：2 年
生产企业为美林美邦（厦门）生物科技有限公司，OEM 品牌为英国璞士诊断有限公司（Prestige Diagnostics
UK Ltd.），英国公司作为欧盟 CE 认证代表，产品可出口在国外销售。
检测步骤：
样本：全血（可用指尖血）
、血清、血浆
检测步骤如下：
说明书
o
2019-nCoV IgG/IgM Device (2-30 C)
CATALOGUE NUMBER KIT SIZE (TESTS) Using the dropper take in whole blood to approximately 1 cm above the fill line then expel 1
full drop (approximately 20 µl) into the sample well. Add 2 drops of buffer to the sample
RADCOV1 20 Tests well (approximately 80 µl) and start the timer.
Using a pipette, transfer 20 µl of whole blood to the sample well, add 2 drops of buffer
Intended Use: (approximately 80 µl) and start the timer.
The 2019-nCoV IgG/IgM Device is a rapid chromatographic immunoassay for the
qualitative detection of IgG and IgM antibodies to 2019-nCoV, a new strain of For Finger Prick Whole Blood:
coronavirus (nCoV), in whole blood, serum and plasma specimen. Using the dropper take in whole blood to approximately 1 cm above the fill line then expel 1
full drop (approximately 20 µl) into the sample well. Add 2 drops of buffer to the sample
well (approximately 80 µl) and start the timer.
Summary: Using a capillary tube, fill the tube with blood by capillary action from the puncture site and
Coronaviruses are a large family of viruses that cause disease ranging from common expel approximately 20 µl into the sample well. Add 2 drops of buffer to the sample well
cold symptoms to more severe pneumonia. They are enveloped, single strand RNA (approximately 80 µl) and start the timer.
viruses. Coronaviruses are zoonotic, they can be transmitted from animals to
humans. Existing examples include the Middle East Respiratory Virus (MER-CoV) and Wait for coloured lines to appear. Read the results at 10 minutes. Do not interpret any
Severe Acute Respiratory Syndrome (SARS-CoV). result after 20 minutes.
Reports of a novel coronavirus began in the Wuhan district of China in December
2019 and in January 2020 the World Health Organisation designated the new strain
2019-nCoV. Symptoms include high temperature, cough and breathing difficulties. In
immunocompromised individuals symptoms can be more severe leading to
pneumonia, severe acute respiratory syndrome or death.
Test Principle:
The test device has anti-human IgG and anti-human IgM immobilized on the
membrane in two distinct areas of the test zone. Particles coated with 2019-nCoV
antigen are loaded on the membrane near the sample well. During the test whole
blood, serum or plasma sample is added to the sample well where it interacts with
the antigen coated particles and any antibodies to 2019-nCoV present in the sample
will bind to the antigen. The antibody-particle complexes migrate up the membrane
by capillary action where they interact with the anti-human IgG and/or anti-human
IgM in the test zone and are captured. A positive result is indicated when a coloured
line forms at the IgG and/or IgM test line. The absence of any line development at
the test zone indicates a negative result. To serve as a procedural control, a coloured
line should always appear at the control line area indicating that proper volume of
specimen has been added and membrane wicking has occurred.
Reagents:
The test device contains anti-human IgG, anti-human IgM, 2019-nCoV antigen and Interpretation of Results:
goat anti-mouse IgG on the membrane of the 2019-nCoV IgG/IgM Rapid Test.
Materials Provided
Individually pouched test devices
Droppers
Buffer
Instructions for Use sheet
Materials not provided: Timer, specimen collection container, centrifuge
Precautions:
For professional in vitro diagnostic use only.
Follow Good Laboratory Practice procedures where samples and kits are handled and treat
the device and all samples as if potentially infectious. Follow local regulations for correct
disposal of samples.
Wear protective clothing including laboratory coat, disposable gloves and safety glasses
when conducting the test. IgG Positive: Two distinct coloured lines appear. One band appears at the control line
Humidity and temperature can adversely affect results. (C) and another band develops at the IgG test line (IgG).
IgM Positive: Two distinct coloured lines appear. One band appears at the control line
(C) and another band develops at the IgM test line (IgM).
Storage and Stability: IgG and IgM Positive: Three distinct coloured lines appear. One band appears at the
The kit can be stored at room temperature or refrigerated (2 - 30oC). The test device is control line (C), one band develops at the IgG test line (IgG) and one band develops at the
stable up to the expiry date printed on the sealed pouch. The device must remain in the IgM test line (IgM).
sealed pouch until use. Do Not Freeze. Do not use after the expiry date. The stability of the NOTE: The intensity of colour development at the test lines will vary depending on
buffer is approximately six months after opening the bottle. the concentration of anti-2019-nCoV IgG or anti-2019-nCoV IgM present in the
sample. Therefore, any shade of colour developing at the test lines should be
considered positive.
Sample Collection and Preparation:
The 2019-nCoV IgG/IgM Device test can be performed using whole blood, serum, or Negative: One coloured line appears in the control region (C). No apparent coloured
plasma. line appear in the test zones.
To collect Finger prick Whole Blood samples: Clean an area of the patient’s fingertip with an
alcohol swab. Allow to dry. Squeeze the hand gently to encourage blood flow to the finger. Invalid: Control line fails to appear. Insufficient specimen volume or incorrect
Pierce the skin with a sterile lancet and wipe away the first sign of blood. Gently squeeze procedural techniques are the most likely reasons for control line failure. Review the
the hand again then the finger to release a large drop of blood over the puncture site. procedure and repeat the test with a new test device. If the problem persists,
Collect the blood drop in the dropper. Do not freeze whole blood samples. Whole blood discontinue using the test kit immediately and contact your local distributor.
collected by finger prick must be tested immediately.
Venepuncture Whole Blood samples: Collect blood by standard venepuncture technique.
The whole blood may be used in the test up to 48 hours after collection if stored at 2 - 8oC. Quality Controls:
Serum and Plasma samples: Separate serum and plasma from red blood cells as soon as A procedural control is included in the test. A coloured line appearing in the control
possible to avoid haemolysis. Use only clear, non-haemolysed samples. EDTA, Heparin region (C) is the internal procedural control. It confirms sufficient specimen volume
citrate and potassium oxalate anticoagulants can be used. Serum and plasma samples may and correct procedural technique. Control standards are not supplied with this kit.
be stored at 2 - 8oC for up to 7 days. For long term storage, samples should be frozen below
-20oC. Frozen samples must be completely thawed and mixed well prior to testing. Samples Limitations of the Test:
should not be repeatedly thawed and re-frozen. If samples are to be shipped, they should
The Assay Procedure and the Assay Result Interpretation must be followed closely
be packed in compliance with local regulations for transportation of etiologic agents.
when testing for the presence of antibodies to 2019-nCoV in whole blood, serum or
plasma from individual subjects. Failure to follow the procedure may give inaccurate
results.
Assay Procedure: The 2019-nCoV IgG/IgM Device is limited to the qualitative detection of anti-2019-
Bring the device, samples, buffer and controls fully to room temperature (15 - 300C) before nCoV IgG and IgM antibodies in the sample types mentioned. The intensity of the test
starting any testing. Remove the test device from the sealed pouch, place it on a clean and band does not have linear correlation with the antibody titer in the specimen.
level surface and use it immediately. A negative result for an individual subject indicates absence of a detectable level of
anti-2019-nCoV IgG and anti-2019-nCoV IgM antibody or that the antibodies are not
For Serum and Plasma samples: present during the stage of disease at which the sample was collected. However, a
Using the dropper take in sample up to the fill line (approximately 10 µl) and transfer it to negative test result does not preclude the possibility of exposure to or infection with
the sample well. Add 2 drops of buffer to the sample well (approximately 80 µl) and start 2019-nCoV.
the timer. See illustration below. The results obtained with this test should not be used as the sole criterion for
Using a pipette, transfer 10 µl of serum or plasma to the sample well, add 2 drops of buffer diagnosis of 2019-nCoV infection, but be used in conjunction with other diagnostic
(approximately 80 µl) and start the timer. procedures and clinical findings.
Hematocrit value of whole blood samples can affect test results. For accurate results
For Venepuncture Whole Blood: the haematocrit level must lie between 25% and 65%.
Prestige Diagnostics UK Ltd, 40 Ballymena Business Centre, Galgorm, Co. Antrim, BT42 1FL, United Kingdom. Tel: +44 (0) 28 25642100
www.prestigediagnostics.co.uk info@prestigediagnostics.co.uk
V1: rev Feb 2020
Performance Characteristics:
The 2019-nCoV IgG/IgM Device has been compared with a commercial PCR test the
results indicating high specificity and sensitivity.
IgG Results
Method PCR
Total Results
2019-nCoV Results Positive Negative
IgG/IgM Positive 20 1 21
Device Negative 0 49 49
Total Results 20 50 70
Relative Sensitivity: 100% (CI*: 86.0% - 100%) *Confidence Intervals
Relative Specificity: 98.0% (95% CI*: 89.4% - 99.9%)
Accuracy: 98.6% (95%CI*: 92.3% - 99.96%)
IgM Results
Method PCR
Total Results
2019-nCoV Results Positive Negative
IgG/IgM Positive 17 2 19
Device Negative 3 48 51
Total Results 20 50 70
Relative Sensitivity: 85.0% (95%CI*: 62.1% - 96.8%)
Relative Specificity: 96.0% (95% CI*: 86.3% - 99.5%)
Accuracy: 92.9% (95% CI*: 84.1% - 97.6%)
Cross-reactivity
The 2019-nCoV IgG/IgM Device has been tested using samples positive for anti-influenza A
virus, , anti-influenza B virus, anti-RSV, anti-adenovirus, HBsAg, anti-syphilis, anti-H pylori,
anti-HIV and anti-HCV. The results showed no cross-reactivity of these samples in the test.
Interfering Substances
Potentially interfering substances commonly found in whole blood, serum and plasma
samples were added to samples at the concentrations stated and used in the test to identify
their effects on the assay. No interference was observed.
Triglyceride: 50 mg/dl Ascorbic Acid: 20 mg/dl
Haemoglobin: 1000 mg/dl Bilirubin: 60 mg/dl
Cholesterol: 6 mg/dl
References:
1. World Health Organisation Statement regarding cluster of pneumonia
cases in Wuhan, China: 9 January 2020.
2. Weiss SR, Lebowitz JL. Coronavirus pathogenesis. Adv Virus Res 2011;
81:85-164.
3. World Health Organisation. Coronavirus. www. who.int/health-topics
/coronavirus.
Glossary of Symbols:
Catalogue number Temperature limitation
Consult instructions for use Batch code
In vitro diagnostic medical device Use by
Manufacturer Do not reuse
Prestige Diagnostics UK Ltd, 40 Ballymena Business Centre, Galgorm, Co. Antrim, BT42 1FL, United Kingdom. Tel: +44 (0) 28 25642100
www.prestigediagnostics.co.uk info@prestigediagnostics.co.uk
V1: rev Feb 2020
Certificate of Registration
This certificate has been awarded to
Prestige Diagnostics UK Ltd
40 Ballymena Business Centre, Galgorm, County Antrim, BT42 1FL, Northern
Ireland
in recognition of the organization's Quality Management System which complies with
ISO 13485:2016
The scope of activities covered by this certificate is defined below
Please refer to the Appendix
Certificate Number: Date of Issue: (Original) Date of Issue:
67400/A/0001/UK/En 10 April 2015 28 February 2019
Issue No: Expiry Date:
7 09 April 2021
Issued by: On behalf of the Schemes Manager
If there is any doubt as to the authenticity of this certificate, please do not hesitate to contact the Head Office of the Group on info@urs-certification.com.
URS is a member of United Registrar of Systems (Holdings) Ltd, United House, 4 Hinton Road, Bournemouth, BH1 2EE, UK. Company Registration no. 5298466 Page 1 of 2Appendix to Certificate
Design, Manufacture and Distribution of In Vitro Diagnostic Assays in
the areas of Clinical Chemistry and Latex Serology, Manufacture and
Distribution of In Vitro Diagnostics Assays in the Areas of Blood
Grouping, Immunoturbidimetry, ELISA, Quality Controls and
Calibrators, Febrile Antigens, Haemostasis, Rapid Tests, Syphilis
Assays and Urine Strips.
Certificate Number: Date of Issue: (Original) Date of Issue:
67400/A/0001/UK/En 10 April 2015 28 February 2019
Issue No: Expiry Date:
7 09 April 2021
If there is any doubt as to the authenticity of this certificate, please do not hesitate to contact the Head Office of the Group on info@urs-certification.com.
URS is a member of United Registrar of Systems (Holdings) Ltd, United House, 4 Hinton Road, Bournemouth, BH1 2EE, UK. Company Registration no. 5298466 Page 2 of 2明
DECLARATION OF CONFORMITY
Prestige Diagnostics UK Ltd
40 Ballymena Business Centre
Galgorm, BT42 1FL, NI, UK
We declare the conformity of products listed below according to
the essential requirements of Annex I of the Directive 98/79/EC on
In Vitro Diagnostic Devices.
The conformity was established by the manufacturer in a
conformity assessment procedure according to Annex III of the
Directive 98/79/EC.
Prestige Diagnostics UK Ltd
4 March 2020
Alan Rodgers
Managing Director
Attached: List of products
Prestige Diagnostics UK Ltd., 40 Ballymena Business Centre, Galgorm, Co. Antrim, BT42 1FL. Tel: +44(0)28 25642100
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Prestige Diagnostics UK Ltd., 40 Ballymena Business Centre, Galgorm, Co. Antrim, BT42 1FL. Tel: +44(0)28 25642100
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Prestige Diagnostics UK Ltd., 40 Ballymena Business Centre, Galgorm, Co. Antrim, BT42 1FL. Tel: +44(0)28 25642100
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