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COVID-19 IgG/IgM Rapid Test Cassette''' Bold text''' (Whole Blood/ Serum/ Plasma) Package Insert A rapid test for the qualitative detection of antibodies (IgG and IgM) to SARS-CoV-2 in whole blood, serum, or plasma. For professional in vitro diagnostic use only

【INTENDED USE】

The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary SARS-COV-2 infections.

【SUMMARY】

COVID-19(Corona Virus Disease) is the infectious disease caused by the most recently discovered coronavirus. This new virus and disease were unknown before the outbreak began in Wuhan, China, in December 2019. The most common symptoms of COVID-19 are fever,tiredness, and dry cough. Some patients may have aches and pains, nasal congestion, runny nose, sore throat or diarrhea. These symptoms are usually mild and begin gradually. Some people become infected but don’t develop any symptoms and don't feel unwell. Most people (about 80%) recover from the disease without needing special treatment. Around 1 out of every 6 people who gets COVID-19 becomes seriously ill and develops difficulty breathing. Older people, and those with underlying medical problems like high blood pressure, heart problems or diabetes, are more likely to develop serious illness. About 2% of people with the disease have died. People with fever, cough and difficulty breathing should seek medical attention. People can catch COVID-19 from others who have the virus. The disease can spread from person to person through small droplets from the nose or mouth which are spread when a person with COVID-19 coughs or exhales. These droplets land on objects and surfaces around the person. Other people then catch COVID-19 by touching these objects or surfaces, then touching their eyes, nose or mouth. People can also catch COVID-19 if they breathe in droplets from a person with COVID-19 who coughs out or exhales droplets. Most estimates of the incubation period for COVID-19 range from 1-14 days. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test that utilizes a combination of SARS-COV-2 antigen coated colored particles for the detection of IgG and IgM antibodies to SARS-COV-2 in human whole blood, serum, or plasma.

'''【PRINCIPLE】 ''' The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 antibodies in whole blood, serum, or plasma. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with SARS-CoV-2 antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region. If the specimen contains IgG antibodies to SARS-CoV-2, a colored line will appear in IgG test line region. In the IgM component, anti-human IgM is coated in IgM test line region. During testing, the specimen reacts with anti-human IgM. IgM antibodies to SARS-CoV-2, if present in the specimen, reacts with the anti-human IgM and the SARS-CoV-2 antigen-coated particles in the test cassette, and this complex is captured by the anti-human IgM, forming a colored line in IgM test line region.

Therefore, if the specimen contains IgG antibodies to SARS-CoV-2, a colored line will appear in IgG test line region. If the specimen contains IgM antibodies to SARS-CoV-2, a colored line will appear in IgM test line region. If the specimen does not contain antibodies to SARS-CoV-2, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

【REAGENTS】 The test cassette contains to specific antigen conjugated gold colloid particles and anti-human IgM, anti-human IgG coated on the membrane.

【PRECAUTIONS】  For professional in vitro diagnostic use only. Do not use after expiration date.  Do not eat, drink or smoke in the area where the specimens or kits are handled.  Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.  Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.  The used tests, specimens and potentially contaminated material should be discarded according to the local regulations.  Humidity and temperature can adversely affect results.

【STORAGE AND STABILITY】

The kit can be stored at room temperature or refrigerated (2-30°C). The test cassette is stable through the expiration date printed on the sealed pouch. The test cassette must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

【SPECIMEN COLLECTION AND PREPARATION】

 The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) can be performed using whole blood, serum, or plasma.  To collect Fingerstick Whole Blood Specimens:  Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry.  Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger.  Puncture the skin with a sterile lancet. Wipe away the first sign of blood.  Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site.  Add the Fingerstick Whole Blood specimen to the test cassette by using a dropper or micropipette measuring 10ul. The dropper provided with the test dispenses approximately 10ul in one drop even if more blood is aspirated in the dropper.  Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, non-hemolyzed specimens.  Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long-term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately.  Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.  If specimens are to be shipped, they should be packed in compliance with federal regulations for transportation of etiologic agents.

【MATERIALS 】 Materials provided Test cassettes Droppers Buffer Package insert Materials required but not provided Specimen collection containers Centrifuge (for plasma only) Micropipette Timer Lancets (for fingerstick whole blood only)

【DIRECTIONS FOR USE】 Allow the test cassette, specimen, buffer, and/or controls to reach room temperature (15-30°C) prior to testing. 1. Bring the pouch to room temperature before opening. Remove the test cassette from the sealed pouch and use it within one hour. 2. Place the test cassette on a clean and level surface.  For Serum or Plasma or Whole Blood Specimens:  To use a dropper: Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 10μl), and transfer the specimen to the specimen well (S) of the test cassette, then add 2 drops of buffer (approximately 80µl) to the buffer well (B) and start the timer. Avoid trapping air bubbles in the specimen well.  To use a micropipette: Pipette and dispense 10µl of specimen to the specimen well (S) of the test cassette, then add 2 drops of buffer (approximately 80µl) to the buffer well (B) and start the timer. 3. Wait for the colored line(s) to appear. The test result should be read at 10 minutes. Do not interpret the result after 20 minutes.



【INTERPRETATION OF RESULTS】 (Please refer to the illustration above) IgG and IgM POSITIVE:* Three lines appear. One colored line should be in the control line region (C), and two colored lines should appear in IgG test line region and IgM test line region. The color intensities of the lines do not have to match. The result is positive for IgG & IgM, antibodies and is indicative of secondary SARS-COV-2 infection. IgG POSITIVE:* Two lines appear. One colored line should be in the control line region (C), and a colored line appears in IgG test line region. The result is positive for SARS-COV-2 virus specific-IgG and is probably indicative of secondary SARS-COV-2 infection.

IgM POSITIVE:*

Two lines appear. One colored line should be in the control line region (C), and a colored line appears in IgM test line region. The result is positive for SARS-COV-2 virus specific-IgM antibodies and is indicative of primary SARS-COV-2 infection.
 * NOTE: The intensity of the color in the IgG and/or IgM test line region(s) will vary depending on the concentration of SARS-COV-2 antibodies in the specimen. Therefore, any shade of color in the IgG and/or IgM test line region(s) should be considered positive.

NEGATIVE: One colored line should be in the control line region (C). No line appears in IgG and IgM test line region(s).

INVALID: Control line fails to appear. Insufficient buffer volume or incorrect procedural

techniques are the most likely reasons for control line failure. Review the procedure and repeat the procedure with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

【QUALITY CONTROL】

An internal procedural control is included in the test. A colored line appearing in the control line region (C) is an internal valid procedural control, it confirming adequate membrane wicking. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

【LIMITATIONS】 1. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of SARS-COV-2 antibodies in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in SARS-COV-2 antibody concentration can be determined by this qualitative test. 2. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) will only indicate the presence of SARS-COV-2 antibodies in the specimen and should not be used as the sole criteria for the diagnosis of SARS-COV-2. 3. In the early onset of fever, anti-SARS-COV-2 IgM concentrations may be below detectable levels. 4. The continued presence or absence of antibodies cannot be used to determine the success or failure of therapy. 5. Results from immunosuppressed patients should be interpreted with caution. 6. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician. 7. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of SARS-COV-2 infection.

【EXPECTED VALUES】

Primary SARS-COV-2 infection is characterized by the presence of detectable IgM antibodies 3-7 days after the onset of infection. Secondary SARS-COV-2 infection is characterized by the elevation of SARS-COV-2-specific IgG. In the majority of the cases, this is accompanied by elevated levels of IgM.

'''【PERFORMANCE CHARACTERISTICS】

Sensitivity and Specificity''' The COVID-19 IgG/IgM Rapid Test Cassette was compared with a leading commercial PCR. The study included 181 specimens for IgG and IgM.

'IgG Results' Method PCR Total Results COVID-19 IgG/IgM Rapid Test Cassette for IgG Results Positive Negative Positive 37 1 38 Negative 1 142 143 Total Results 38 143 181 Sensitivity: 97.4% (95%CI: 86.2%~99.9%)* Specificity: 99.3% (95%CI: 96.2%~99.9%)* Accuracy: 98.9 %( 95%CI: 96.1%~99.9%)* *Confidence Interval

IgM ResultsBold text

Method PCR Total Results COVID-19 IgG/IgM Rapid Test Cassette for IgM Results Positive Negative Positive 33 2 35 Negative 5 141 146 Total Results 38 143 181 Sensitivity: 86.8 %( 95%CI: 71.9%-95.6%)* Specificity: 98.6 %( 95%CI: 95.0%~99.8%)* Accuracy: 96.1 %( 95%CI: 92.2%~98.4%)* *Confidence interval

Cross-reactivity The COVID-19 IgG/IgM Rapid Test Cassette (whole blood/Serum/Plasma) has been tested for anti-influenza A virus, anti-influenza B virus, anti-RSV, anti-Adenovirus, HBsAg, anti-Syphilis, anti-H. Pylori, anti-HIV and anti-HCV positive specimens. The results showed no crossreactivity. Interfering Substances The following potentially interfering substances were added to SARS-CoV-2 negative and positive specimens. Acetaminophen: 20 mg/dL Caffeine: 20 mg/dL Albumin: 2 g/dL Acetylsalicylic Acid: 20 mg/dL Gentisic Acid: 20 mg/dL Ethanol: 1% Ascorbic Acid: 2g/dL Creatine: 200mg/dl Bilirubin: 1g/dL Hemoglobin: 1000mg/dl Oxalic Acid: 60mg/dL Uric acid: 20mg/ml None of the substances at the concentration tested interfered in the assay.

【BIBLIOGRAPHY】 1. World Health Organization (WHO). WHO Statement Regarding Cluster of Pneumonia Cases in Wuhan, China. Beijing: WHO; 9 Jan 2020. 2. Weiss SR, Leibowitz JL. Coronavirus pathogenesis. Adv Virus Res 2011;81:85-164. 3. Cui J, Li F, Shi ZL. Origin and evolution of pathogenic coronaviruses. Nat Rev Microbiol 2019; 17:181-192. 4. Su S, Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. TrendsMicrobiol 2016;24:490-502.