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Now offering reliable COVID-19 and Respiratory Pathogen testing! Call today to set up your on-site test collection.

Alcala Labs call centers are ready to schedule your appointment.

Call us at (619) 450 5870 and speak to our Team at Alcala Labs.

Alcala Labs is offering SARS-CoV-2 (COVID-19) testing to cover viral detection by COVID-19 RNA testing and antibody tests for IgG and IgM. Effectively covering the full spectrum of COVID-19 infectious disease progression is crucial in identifying affected individuals at different stages of a possible exposure.

Additionally, differential testing and determination of co-infections can be tested to rule out 20 other possible respiratory viral or bacterial pathogens.

SARS-CoV-2 RNA confirmation

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Rule out 20 other Respiratory Pathogens

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Detect recent exposure and immunity by IgG and IgM Testing

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Clinical Test Information:

 

 

The NxTAG® CoV Extended Panel (NxTAG CoV) is an EUA-approved (Emergency Use Authorization) test authorized by the FDA for use by high-complexity, CLIA-certified laboratories such as Alcala Labs. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The NxTAG® CoV Extended Panel incorporates multiplex Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) with the Luminex® proprietary universal tag sorting system on the Luminex platform to easily detect SARS-CoV-2. Extracted total nucleic acid is added to pre-plated, Lyophilized Bead Reagents (LBRs) and mixed to resuspend the reaction reagents. The reaction is amplified via RT-PCR and the reaction product undergoes near simultaneous bead hybridization within the sealed reaction well. The hybridized, tagged beads are then sorted and read on the MAGPIX® instrument.

Sensitivity: The Limit of Detection (LoD) study established the lowest SARS-CoV-2 viral concentration (Genomic Copy Equivalents or GCE = 5.00E+03 GCE/mL) that can be detected by the NxTAG® CoV Extended Panel Assay at least 95% of the time using viral genomic RNA. 100% at 3X LoD and 5X LoD.

Specificity: 100% PPV and NPV.

 

NxTAG® Respiratory Pathogen Panel (RPP) DNA/RNA swab test for In Vitro Diagnostic Use (IVD), incorporates multiplex Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) with the Luminex® proprietary universal tag sorting system on the Luminex platform to easily detect respiratory pathogen targets. Extracted total nucleic acid is added to pre-plated, Lyophilized Bead Reagents (LBRs), and mixed to resuspend the reaction reagents. The reaction is amplified via RT-PCR and the reaction product undergoes near simultaneous bead hybridization within the sealed reaction well. The hybridized, tagged beads are then sorted and read on the MAGPIX® instrument, and the signals are analyzed using the NxTAG Respiratory Pathogen Panel Assay File for SYNCT™ Software, providing a reliable, qualitative call for each of the 20 targets and internal controls within each reaction well.

 

 

COVID-19 IgG and IgM antibodies in venipuncture serum draws: are determined by COVID-19 ELISA Diagnostics kits developed by Epitope Diagnostics, Inc: KT-1032 EDI™ Novel Coronavirus COVID-19 IgG ELISA Kit and KT-1033 EDI™ Novel Coronavirus COVID-19 IgM.

The ELISA kits utilized for this test are designed, developed, and produced for the qualitative measurement of the human anti-COVID-19 IgG or IgM antibody in serum and utilizes the microplate based enzyme immunoassay technique. Assay controls and 1:100 or 1:10 diluted human serum samples are added to the microtiter wells of a microplate that was coated with COVID-19 recombinant full length nucleocapsid protein. After the first incubation period, the unbound protein matrix is removed with a subsequent washing step. A horseradish peroxidase (HRP) labeled polyclonal goat anti-human IgG tracer antibody is added to each well. After an incubation period, an immunocomplex of “COVID-19 recombinant antigen – human anti-COVID-19 IgG antibody – HRP labeled anti human IgG tracer antibody” is formed if there is specific coronavirus IgG antibody present in the tested specimen. The unbound tracer antibody is removed by the subsequent washing step. HRP tracer antibody bound to the well is then incubated with a substrate solution in a timed reaction and then measured in a spectrophotometric microplate reader. The enzymatic activity of the tracer antibody bound to the anti-COVID-19 IgG on the wall of the microtiter well is proportional to the amount of the anti-COVID-19 IgG antibody level in the tested specimen.

Epitope Diagnostics, Inc. confirms that the materials are compliant with the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) guideline issued on May 4, 2020. The products are still eligible for distribution as in vitro diagnostics to laboratories certified to perform high complexity testing, and at the point-of care when covered by the laboratory’s CLIA certificate for highcomplexity testing. The test kit method and performance criteria were submitted to the Federal Drug Administration (FDA) under two routes: Emergency Use Authorization (EUA) and NOTIFY per Section IV.D of the Policy for Diagnostic Tests for Coronavirus Disease-2019.

Test Performance IgG: Serum samples from two cohorts of patients were tested using the IgG ELISA kit at the Jiaxing City Center for Disease Control and Prevention and Zhejiang University Hospital. The combined cohort consisted of normal healthy patients with samples collected prior to the COVID-19 outbreak [December 3, 2019] (n = 54) and RT-PCR confirmed positive patients after the second week of the onset of the disease (n = 30). The results are as follows:

                                   Test Positive       Test Negative

Test Positive           30                             0

Test Negative         0                               54

For IgG the diagnostic sensitivity is 100%, the diagnostic specificity is 100%, the negative predictive value is 100%, the positive predictive value is 100%.

Test Performance IgM: Serum samples from two cohorts of patients were tested using the IgM ELISA kit at the Jiaxing City Center for Disease Control and Prevention and Zhejiang University Hospital. The combined cohort consisted of normal healthy patients with samples collected prior to the COVID-19 outbreak [December 3, 2019] (n = 54) and RT-PCR confirmed positive patients after the second week of the onset of the disease (n = 20). The results are as follows:

                                   Test Positive        Test Negative

Test Positive            9                               0

Test Negative         10                              54

Test Borderline      1                                0

For IgM the diagnostic sensitivity is 45%, the diagnostic specificity is 100%, the negative predictive value is 83.1%, the positive predictive value is 100%.

 

 

The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is an EUA-approved lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, plasma from anticoagulated blood (Li+ heparin, K2-EDTA and sodium citrate), or serum. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests.

Results are for the detection of SARS CoV-2 antibodies. IgM and IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

The sensitivity of COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) early after infection in unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary. False positive results for COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive results, confirmation of positive results should be considered using a second, different IgG or IgM assay such as the Serum ELISA test described above.

The clinical performance of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) was evaluated by testing a total of 191 plasma (K2-EDTA) clinical samples – 90 positive samples and 101 negative samples from individual patients exhibiting pneumonia, respiratory symptoms and fever etc. Testing was performed at two sites in China from January to mid-March 2020. COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) results for IgM and IgG detection were compared to the results of RT-PCR assays for SARSCoV-2 from oropharyngeal swabs (Site #1) and sputum (Site #2).

  • Measure
  • IgM Sensitivity
  • IgG Sensitivity
  • (IgM+ or IgG+; Total) Sensitivity (PPA)
  • (IgM-/IgG-; Total) Specificity (NPA)
  • Cross-reactivity with HIV+
  • Estimate
  • 100% (30/30)
  • 96.7% (29/30)
  • 100% (30/30)
  • 97.5% (78/80)
  • 0% (0/10) – not detected
  • Confidence Interval
  • (88.7%; 100%)
  • (83.3%; 99.4%)
  • (88.7%; 100%)
  • (91.3%; 99.3%)

Watch this Video to see how the COVID-19 Rapid Cassette test works: