We determine if the SARS-CoV-2 in your nose is a Delta, an Omicron or another variant/strain by DNA sequencing

Now, you can send a nasopharyngeal swab sample collected by a healthcare provider and ship the sample on the same day via FEDEX next morning delivery on a working day (not on Holidays or weekends) to Milford Molecular Diagnostics Laboratory according to the following instructions. https://www.fedex.com/en-us/shipping/how-to-ship-clinical-samples.html with an ice pack to keep the sample cold during transit.

We will perform 3 Sanger sequencings on the ACE2 RBD, NTD and N-gene as listed in the Table above  https://www.mdpi.com/1999-4915/13/12/2386 to determine the variant, including the Omicron and the Delta, in your specimen, and send the report with Sanger sequencing results to you by email.

Click here for the Requisition Form  

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SARS-CoV-2 detection by partial N gene sequencing now at CLIA Certified Milford Connecticut laboratory

• Lyme disease ^1-5
• Chlamydia trachomatis ^6,7
• Neisseria gonorrhoeae ^6,7
• Human papillomavirus (HPV) detection and genotyping ^8-13
• BRCA1 and BRCA2 Ashkenazi Jewish founder mutations screen ¹⁴

   Accurate results of these five tests are crucial in assisting physicians to provide better care for their patients.

   The Lyme disease test is performed on an EDTA whole blood sample. The gynecology DNA tests , can be performed on 10% of a ThinPrep or SurePath Pap cervical cytology collection.

   The American College of Obstetricians and Gynecologists (ACOG) has recommended that screening for hereditary breast and ovarian cancer be part of the routine services provided by women’s health care physicians. Please read: ACOG recommendation

   Our CLIA-approved tests are unique in that all positive or genotyping reports contain a diagnostic Sanger sequencing electropherogram as objective physical evidence for molecular validation, like the EKG in a cardiologist’s consultation report. Sanger sequencing is the gold standard for all nucleic acid tests. For example, the FDA advises the medical device manufacturers of human papillomavirus test kits as follows:

   One way to do this is to perform an FDA-approved HPV test that detects the same genotypes as your test, or you may perform PCR followed by sequencing of the amplicon (PCR/Sequencing) on your clinical specimens and compare these results to the results of your device.”  ¹⁵

   There are at least 40 HPV genotypes prevalent in the cervical cell samples from women living in Connecticut.

   In addition to achieving high specificity, we use nested PCR to increase the detection sensitivity, which is also crucial because the copies of HPV DNA may drop from thousands down to <10 per cell during the course of cancer development. The density of spirochetes is usually below 100 per 1 mL of venous blood in Lyme disease patients.  

   According to one analysis by the New York State HPV Proficiency Test program, the accuracy of 40% of the results generated by commercial test kits was questionable.¹³ Using the results of these commercial HPV test kits for triage, more than 95% of the patients referred to colposcopic biopsies for diagnostic workup have been found to be unnecessary and potentially excessive.¹⁶   If HPV assays are used as a primary tool for cervical screen for cervical cancer prevention, triage to colposcopic biopsy should be based on at least two positive samples taken more than 6 months apart showing the same HPV genotype by DNA sequencing in both samples with companion abnormal Pap cytology in order to reduce the unnecessary harmful colposcopic biopsies.^13,17

   Milford Molecular Diagnostics is the only laboratory that can diagnose low-density bacteremia in Lyme disease patients.⁴

For more information regarding the cited research, please visit our REFERENCES page to find details behind the footnote references.