2 pieces rapid self test kit testing tester temprcher corona test

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Description

2 pieces rapid self test kit testing tester temprcher corona test

n CoV-19 IgG/IgM Rapid Test Device Package Insert
It is Widely used in China
and it Help Chinese people beat the virus
2 pieces rapid self test kit testing tester temprcher corona test

2 pieces rapid self test kit testing tester temprcher corona test2 pieces rapid self test kit testing tester temprcher corona test2 pieces rapid self test kit testing tester temprcher corona test2 pieces rapid self test kit testing tester temprcher corona test2 pieces rapid self test kit testing tester temprcher corona test2 pieces rapid self test kit testing tester temprcher corona test2 pieces rapid self test kit testing tester temprcher corona test

INTENDED USE

The nCoV-19 IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG anti–nCoV-19 virus and IgM anti-nCoV-19 virus in human whole blood, serum or plasma. It is intended to be used by the professionals as a screening test and as an aid in the diagnosis of infection with nCoV-19 viruses. Any reactive specimen with the nCoV-19 IgG/IgM Rapid Test must be confirmed with alternative testing method(s).

INTRODUCTION

Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds and that cause respiratory, enteric, hepatic, and neurologic diseases.1,2 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 Given the high prevalence and wide distribution of coronaviruses, the large genetic diversity and frequent recombination of their genomes, and increasing human–animal interface activities, novel coronaviruses are likely to emerge periodically in humans owing to frequent cross-species infections and occasional spillover events.4,5
The nCoV-19 IgG/IgM Rapid Test detects IgG and IgM anti-nCoV-19 virus in one test within 15 minutes. The test is user friendly, without cumbersome laboratory equipment, and requires minimal staff trainings.

PRINCIPLE
The nCoV-19 IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) is a qualitative membrane-based immunoassay for the detection of nCoV-19 antibodies in whole blood, serum, or plasma. This test consists of two components, an IgG component and an IgM component. In the Test region, anti-human IgM and IgG is coated. During testing, the specimen reacts with nCoV-19 antigen-coated particles in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgM or IgG in test line region. If the specimen contains IgM or IgG antibodies to nCoV-19, a colored line will appear in test line region.
Therefore, if the specimen contains nCoV-19 IgM antibodies, a colored line will appear in test line region M. If the specimen contains nCoV-19 IgG antibodies, a colored line will appear in test line region G. If the specimen

does not contain nCoV-19 antibodies, 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 appeared in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

KIT COMPONENTS

Individually packed test devices Each device contains a strip with colored conjugates and reactive reagents pre-spreaded at the corresponding regions
Disposable pipettes For adding specimens use
Buffer Phosphate buffered saline and preservative
Package insert For operation instruction
 

MATERIALS
Materials Provided

  • Test devices
  • Droppers
  • Buffer
  • Package insert

Materials Required But Not Provided

  • Specimen collection containers
  • Timer
  • Centrifuge

WARNINGS AND 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 testing 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 being tested.
  • Humidity and temperature can adversely affect results.

REAGENT PREPARATION AND STORAGE INSTRUCTIONS
All reagents are ready to use as supplied. Store unused test devices unopened at 2°C-30°C. The positive and negative controls should be kept at 2°C-8°C. If stored at 2°C-8°C, ensure that the test device is brought to room temperature before opening. The test device is stable through the expiration date printed on the sealed pouch. Do not freeze the kit or expose the kit over 30°C.

SPECIMEN COLLECTION AND HANDLING
Consider any materials of human origin as infectious and handle them using standard biosafety procedures.
Capillary Whole Blood
Wash the patient’s hand then allow to dry. Massage the hand without touching the puncture. 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 device by using a capillary tube or hanging drops.
Venous Whole Blood:
Collect blood specimen into a lavender, blue or green top collection tube (containing EDTA, citrate or heparin, respectively in Vacutainer®) by veinpuncture.

NTERPRETATION OF ASSAY RESULT

2 pieces rapid self test kit testing tester temprcher corona test

 

POSITIVE RESULT:
2 pieces rapid self test kit testing tester temprcher corona test

IgG Positive:* The colored line in the control line region (C) appears and a colored line appears in test line region G (G). The result is positive for nCoV-19 specific-IgG and is probably indicative of secondary nCoV-19 infection.

2 pieces rapid self test kit testing tester temprcher corona test

IgM Positive:* The colored line in the control line region (C) appears and a colored line appears in test line region M (M). The result is positive for nCoV-19 virus specific-IgM antibodies and is indicative of primary nCoV-19 infection.

2 pieces rapid self test kit testing tester temprcher corona test

IgG and IgM Positive:* The colored line in the control line region (C) appears and two colored lines should appear in test line regions G and M (G and M). The color intensities of the lines do not have to match. The result is positive for IgG & IgM antibodies and is indicative of secondary nCoV-19 infection.
*NOTE: The intensity of the color in the test line region(s) (G and M) will vary depending on the concentration of nCoV-19 antibodies in the specimen. Therefore, any shade of color in the test line region(s) (G and M) should be considered positive.
NEGATIVE RESULT:
2 pieces rapid self test kit testing tester temprcher corona test
The colored line in the control line region (C) appears. No line appears in test line regions G and M (G and M).

INVALID RESULT:
2 pieces rapid self test kit testing tester temprcher corona test

Control line (C) falls 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 device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

 

nCoV-19 IgM Rapid Test

 

PCR Results

Positive

Negative

Total

Positive

42

2

44

Negative

0

102

102

Total

42

104

146

Relative Sensitivity: 95.5% (89.3%~100%)
Relative Specificity: 100% (99.8%~100%)
Overall Agreement: 98.6% (96.7%~100%) 95%CI

2. Clinical Performance For IgG Test

A total of 156 patient samples from susceptible subjects were tested by the nCoV-19 IgG/IgM Rapid Test and by a reference PCR. Comparison for all subjects is showed in the following table:

 

nCoV-19 IgG/IgM Rapid Test

 

PCR Results

Positive

Negative

Total

Positive

54

0

54

Negative

2

100

102

Total

56

100

156

Relative Sensitivity: 100% (99.7%~100%)
Relative Specificity: 98.0% (95.4%~100%)
Overall Agreement: 98.7% (97.0%~100%) 95%CI

LIMITATIONS OF TEST

  1. The Assay Procedure and the Test Result Interpretation must be followed closely when testing the presence of antibodies to nCoV-19 virusin serum or plasma from individual subjects. Failure to follow the procedure may give inaccurate results.
  2. The nCoV-19 IgG/IgM Rapid Test is limited to the qualitative detection of antibodies to nCoV-19 virus in human whole blood, serum or plasma. The intensity of the test band does not have linear correlation with the antibody titer in the specimen.
  3. The nCoV-19 IgG/IgM Rapid Test can not be used to differentiate if the infection is primary or secondary. No information of nCoV-19 serotypes can be provided with this test.
  4. A negative or non-reactive result for an individual subject indicates absence of detectable nCoV-19 virus antibodies. However, a negative or non-reactive test result does not preclude the possibility of exposure to or infection with nCoV-19 virus.

A negative or non-reactive result can occur if the quantity of the nCoV-19 virus antibodies present in the specimen is below the detection limits of the assay, or the

REFERENCES

1. Weiss SR, Leibowitz JL. Coronavirus pathogenesis. Adv Virus Res 2011;81:85-164.
2. Masters PS, Perlman S. Coronaviridae. In: Knipe DM, Howley PM, eds. Fields virology. 6th ed. Lippincott Williams & Wilkins, 2013:825-58.

  1. Su S, Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. Trends Microbiol 2016;24:490-502.
  2. Cui J, Li F, Shi ZL. Origin and evolution of pathogenic coronaviruses. Nat Rev Microbiol 2019;17:181-192.
  3. Wong G, Liu W, Liu Y, Zhou B, Bi Y, Gao GF. MERS, SARS, and Ebola: the role of super-spreaders in infectious disease. Cell Host Microbe 2015;18:398-401.
  4. Report of clustering pneumonia of unknown etiology in Wuhan City. Wuhan Municipal Health Commission, 2019.

 

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