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DIAGNOSTICS

Point-of-Care Testing

The arrival of next generation advanced diagnostic point-of-care tests is here. True Diagnostics goes beyond the traditional clinic setting and provides access to lab-quality diagnostics in even the most remote settings. The TrueDX PlatformTM enhances the ease of use and economics of scale over conventional diagnostic technologies, thereby allowing for greater market opportunities. True Diagnostics, Inc. were able to open up new market opportunities in emerging markets, including in the People’s Republic of China, leveraging the TrueDX PlatformTM.

QuikPacII™ is the New Rapid Test That Provides Accurate Immune Response to COVID-19 Infection Diagnosis in 15 Minutes.

It is widely accepted that IgM provides the first line of defense during viral infections, followed by the generation of adaptive, high affinity IgG responses for long term immunity and immunological memory. Testing of COVID-19 IgM and IgG antibodies is an effective method for the rapid diagnosis of Immune Response to COVID-19 infection. Detection of COVID-19 IgM antibodies to indicate a recent exposure to COVID-19, whereas detection of COVID-19 IgG antibodies indicates a later stage of infection. Thus, this combined antibody test could also provide information on the stage of immune response to infection.

It can be used for rapid screening of carriers of the virus that are symptomatic or asymptomatic. Recent studies suggest that a high percentage of patients show no clinical symptoms of the virus, thus screening patients is vitally important. The test is ideally suited for hospitals, clinics and test laboratories. The test can also be effectively deployed in businesses, schools, airports, seaports and train stations, etc., giving it the potential to become a compelling force in the fight against this global threat.

True Diagnostics, Inc.

2782 Loker Ave West
Carlsbad, CA 92010

Phone: 888-571-8597

info@truediag.com

The test was validated using 602 clinically positive and negative patient samples. The overall test sensitivity of QuikPacII™ COVID-19 IgG/IgM is 89.4% and specificity is 97.7%. • For Rx use only. • This test has not been reviewed by the FDA. For use in clinical laboratories by health care professionals following FDA guidance “Policy for Diagnostic Tests for Coronavirus Disease-2019 (COVID-19) during the Public Health Emergency”. • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic assay should be considered to rule out infection in these individuals. • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. • Not for the screening of donated blood. • For Export Use Only

Related Products

TrueDXP Disposable ReaderTM

Accurate Digital Results at your Fingertips

With the TrueDXP Disposable Reader there is no need to interpret lines or configure your smart device. The TrueDXP Disposable Reader brings a new dimension to portable quantitative testing.

  • Prevents Cross-Contamination
  • Portable & Lightweight
  • Inexpensive
  • Convenient and Easy to Use
  • Multiple Test Lines and Events are Distinguishable
Features:
  • Quantitative and/or Qualitative Results
  • High Sensitivity and Reproducibility
  • Highly Sensitive LED Sensor
  • Available for Diagnostic/Research Applications
  • IVD, Veterinary, Forensic and Food Diagnostics
Specifications:

Dimensions: 4.56×0.91×0.52″
Weight: 17g
Display: 1″
Output Ports:

– 1 Mini USB Port
– Bluetooth (Optional)

TrueDX ReaderTM

reader01

Mobile Diagnostics Without Compromise.

The TrueDX Reader combines the strengths of rapid point-of-care diagnostics with central lab performance. The TrueDX reader is an innovative platform that will transform the point-of-care markets.

  • Portable & Lightweight
  • Inexpensive
  • Convenient and Easy to Use
  • Multiple Test Lines and Events are Distinguishable
Features:
  • Quantitative and/or Qualitative Results
  • High Sensitivity and Reproducibility
  • Highly Sensitive CMOS Image Sensor
  • 2D-Matrix Interface
  • Available for Diagnostic/Research Applications
  • IVD, Veterinary, Forensic and Food Diagnostics
  • QC Check for Clinical Laboratories
Specifications:

Dimensions: 24x11x10cm
Weight: approximately 700g
Display: 5″ Resistive Touch Screen
Output Ports:

– 2 USB Ports
– 1 Mini USB Port
– Wi-Fi enabled (Optional)
– Bluetooth (Optional)

Test Assays

All TrueDX AssaysTM are stable at room temperature for up to 18 months. Our proprietary calibration method allows us to extend our shelf life stability over traditional methods that use a pre-set standard curve.

Click to Expand Each Category
Thyroid Profile
Product Name: TSH
Format: Cassette
Package: 25 Tests/Case
Specimen: Whole Blood or Serum
Sample Volume: 30 µl (WB)

Product Name: Free-T4
Format: Cassette
Package: 25 Tests/Case
Specimen: Whole Blood or Serum
Sample Volume: 30 µl (WB)

Cardiac Profile
Product Name: NT-proBNP
Format: Cassette
Package: 25 Tests/Case
Specimen: Whole Blood or Serum
Sample Volume: 30 µl (WB)

Product Name: CKMB
Format: Cassette
Package: 25 Tests/Case
Specimen: Whole Blood or Serum
Sample Volume: 30 µl (WB)

Product Name: Troponin I
Format: Cassette
Package: 25 Tests/Case
Specimen: Whole Blood or Serum
Sample Volume: 30 µl (WB)

Product Name: Myoglobin
Format: Cassette
Package: 25 Tests/Case
Specimen: Whole Blood or Serum
Sample Volume: 30 µl (WB)

Cancer Markers
Product Name: PSA
Format: Cassette
Package: 25 Tests/Case
Specimen: Whole Blood or Serum
Sample Volume: 30 µl (WB)

Product Name: AFP
Format: Cassette
Package: 25 Tests/Case
Specimen: Whole Blood or Serum
Sample Volume: 30 µl (WB)

Product Name: CEA
Format: Cassette
Package: 25 Tests/Case
Specimen: Whole Blood or Serum
Sample Volume: 30 µl (WB)

Fertility Profile
Product Name: HCG
Format: Cassette
Package: 25 Tests/Case
Specimen: Urine / Whole Blood or Plasma
Biologics
Product Name: Rituximab
Format: Cassette
Package: 25 Tests/Case
Sample: Biologic/Biosimilar
Sample Volume: 1 µl

Product Name: Natalizumab
Format: Cassette
Package: 25 Tests/Case
Sample: Biologic/Biosimilar
Sample Volume: 1 µl

Product Name: Trastuzumab
Format: Cassette
Package: 25 Tests/Case
Sample: Biologic/Biosimilar
Sample Volume: 1 µl


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True Diagnostics, Inc. is a research, development and manufacturing company specializing in accurate, affordable and easy-to-use advanced rapid in-vitro immunodiagnostic test systems and reagents . The Company obtains licenses as a Medical Device Establishment by the United States Food and Drug Administration (FDA) and the State of California Department of Health Services, Food and Drug Branch, and receives FDA 510(k) approval for the products it offers.

Contact Info

  • True Diagnostics, Inc.
  • 5919 Farnsworth Court • Carlsbad, CA 92008
  • 888-571-8597
  • info@truediag.com
  • https://truediag.com

© 2023 · True Diagnostics

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