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MedQuest has partnered with MTJR to distribute the PCL COVID19 Rapid Gold IgG/IgM Antibody Test Kits. The MTJR partnership details include a 40% profit sharing agreement for PCL tests sold in North and South America.
The following overview describes the PCL COVID19 Rapid Gold IgG/IgM Antibody Test Kits and how they function.
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HIGH PERFORMANCE AND LOW COST DIAGNOSTIC TESTING PLATFORM
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- 3D Sol-gel capturing system: Platform for diagnosis of multiple infectious diseases (Immunodiagnostics)
- A disease marker immobilization technology that is 1,000 times more sensitive than existing technology, with no cross-reactions or interference
- 3D Chip Advantage: immobilize high concentration of probes without increasing surface area
- High sensitivity (fM level)
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1,000x more sensitive than existing diagnostic technology
- 3D network of pores connected by larger channels
- Size Exclusive Sol-gel › low background, high specificity
COVID-19 GLOBAL PANDEMIC SITUATION TOTAL SOLUTION
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| Test | Antibody IgG/IgM | RT-PCR |
|---|---|---|
| Confirmation Test | ✗ | ✔ |
| Rapid Screening | ✔ | ✗ |
| Sample | Blood | Nasal Swab |
| Patients with COVID-19 Symptoms | ✔ | ✔ |
| Patients with other Symptoms | ✔ | ✗ |
| Patients without symptoms | ✔ | ✗ |
| Point-of-Care | ✔ | ✗ |
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COVID-19 TOTAL SOLUTION BY PCL INC.
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10 min qualitative detection of COVID-19 IgG/IgM antibody blood samples
No analyzer needed
TEST RESULTS INTERPRETATION
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| Result | Interpretation |
|---|---|
| IgM positive / IgG negative | Early infection, able to transmit infection |
| IgM positive / IgG positive | Acute or recent infection, able to transmit infection. |
| IgM negative / IgG positive | Infection resolved, not likely to transmit infection |
| IgM negative / IgG negative | Either not infected or at early onset of infection when only RT-PCR test can be used to confirm |
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Substances listed below are confirmed not to have cross-reactivity with PCL COVID-19 IgG/IgM Rapid Gold.
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Influenza A IgM
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Influenza B IgM
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RSV IgM
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Parainfluenza IgM
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Mycoplasma pneumoniae IgM
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Chlamydia pneumoniae IgM
Substances listed below are confirmed not to have interference with PCL COVID-19 IgG/IgM Rapid Gold.
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Hemoglobin
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Bilirubin
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Triglycerides
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Cholesterol
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Rheumatoid Factor
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EDTA
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Sodium citrate
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Heparin Sodium
PCL COVID19 Rapid Gold IgG/IgM Test Kit Clinical Results
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| Performance | IgM | IgG | Total |
|---|---|---|---|
| Sensitivity | 70.6% [84/119] | 87.4% [104/119] | 90.8% [108/119] |
| Specificity | 99.9% [1080/1081] | 99.4% [1074/1081] | 99.4% [1074/1081] |
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ACCURACY AND SENSITIVITY/SPECIFICITY
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ACCURACY
| IgM | IgG | IgG/IgM | |
|---|---|---|---|
| Institutional 1 | 87.5% (14/16) | 100% (16/16) | 100% (16/16) |
| Institutional 2 | 98.6% (286/290) | 99.9% (287/290) | 99.7% (289/290) |
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SENSITIVITY
| IgM | IgG | IgG/IgM | |
|---|---|---|---|
| Institutional 1 | 100% (5/5) | 100% (7/7) | 100% (7/7) |
| Institutional 2 | 100% (16/16) | 90.5% (19/21) | 100% (19/19) |
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SPECIFICITY
| IgM | IgG | IgG/IgM | |
|---|---|---|---|
| Institutional 1 | 81.8% (9/11) | 100% (9/9) | 100% (9/9) |
| Institutional 2 | 98.5% (270/274) | 99.6% (268/269) | 99.6% (270/271) |
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ANTIBODY TEST CLINICAL EVALUATION
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Using Nasopharyngeal/Oropharyngeal samples confirmed positives and negatives by RT-PCR [PCL MDTM nCoV one step RT-PCR Kit].
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Percent Positive Agreement
| Institution | IgM | IgG | IgG/IgM |
|---|---|---|---|
| 1 | 71% (5/7) | 100% (7/7) | 100% (7/7) |
| 2 | 80% (15/20) | 95% (19/20) | 95% (19/20) |
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Percent Negative Agreement
| Institution | IgM | IgG | IgG/IgM |
|---|---|---|---|
| 1 | 100% (9/9) | 100% (9/9) | 100% (9/9) |
| 2 | 100% (270/270) | 99.2% (268/270) | 100% (270/270) |
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