MOLECULAR DIAGNOSTICS :: STIs
enced laboratorians retiring. And on top of that, the pandemic forced many people to postpone health screenings.” “Now, as patients get back to doctors’ offices to catch-up on delayed screenings, we’re likely to see testing volumes rise to pre-COVID numbers or higher,” Walker continued. “That means those same already short- staffed labs will be—forgive the word choice—sorely tested themselves. It’s a perfect storm of reduced staff—and less senior staff—coupled with higher demand as well as supply chain chal- lenges to secure inventory of the actual tests themselves. Walker says labs need to take full
advantage of automated- and AI-driven or supported processes. He notes how remote system monitoring, redundancy of sub-systems and long walkaway times can help reduce the likelihood of human error while helping meet the demand challenges presented by staffing short- ages and increased patient demand on testing resources.
“Integrated automation of the pre-
analytical workflow, as well as onboard- ing capacity of reagents and specimens, enable delivery of several hundred more test results than a human worker can produce with limited intervention – and in a much shorter timeframe,” Walker added.
Sample transport When patients are waiting hours, days, or even weeks for the results of STD tests, the last thing they want to hear is that the testing was inconclusive and will have to be performed again. Preservation of the specimen during transport from the point of testing to the lab for processing is critical to accurate test processing. “Efficient collection and accurate results are critical aspects of all patient testing,” said Virginia Templet, Director of Marketing, Puritan Medical Products. “When testing for STIs that can be identi- fied through specimen collection with a swab, consider Puritan’s UniTranz-RT universal transport media product. This medium is available in 1ml and 3ml vials or combined with a flock swab, designed with the patient in mind. For your gy- necological patients, choose Puritan’s large rayon tip swab, Histobrush and the Rovers family of cervix brushes, all from Puritan.”
Some STD viruses are more suscep-
tible to damage during transport. One of the most common STDs, the herpes simplex virus (HSV), is highly sensitive to desiccation and pH inactivation, and the virus infectivity is heat labile. Therefore,
BD CTGCTV2 assay for the BD MAX System
the “specimen should also be transferred quickly to a diagnostic virology labora- tory on ice (+4°C).”4
HPV Testing
As the Centers for Disease Control and Prevention (CDC) reports, Human Papillomavirus (HPV) “is so common that nearly all sexually active men and women get the virus at some point in their lives.”5 In the U.S., there are an estimated 42.5M HPV infections - new or existing – at any given time.6 “It’s important to consider HPV when talking about STI screening because almost all cervical cancer is caused by high-risk HPV,” said Walker. “There are 14 high-risk HPV genotypes, and each high- risk genotype is associated with a differ- ent level of risk of progression to cervical pre-cancer and cancer. BD Onclarity HPV Assay is the only FDA-approved assay with extended genotyping, reporting six high-risk HPV genotypes individu- ally, including HPV 31. The assay with extended genotyping, is a more precise, accurate way to measure a woman’s risk for developing cervical pre-cancer and cancer.”
Run on the BD COR System, Walker
says labs using the BD Onclarity HPV Assay can provide clinicians with more advanced insight on women’s health and more informed treatment options for cli- nicians. The BD COR System integrates and automates the complete molecular laboratory workflow from pre-analytical processing to diagnostic test result, trans- ferring the sample from the liquid-based cytology (LBC) collection to a molecular aliquot tube for HPV testing. It replaces labor-intensive and error-prone manual
processes with automated ones, and the system is modular and scalable, designed to address multiple laboratory needs for expanding molecular testing and increas- ing test volumes.
Syphilis testing While STDs, such as syphilis and gonor- rhea, have been widely recognized for centuries, clinical labs still struggle with the accuracy and efficiency of diagnostic tools. With the rise in highly infectious primary and secondary (P&S) syphilis rates since a historic low in 2001,7
re-
searchers are focusing on ways to achieve earlier diagnosis. A Comparative Analysis of Molecu-
lar and Serologic Testing for Primary Syphilis, published in the Frontiers in Cellular and Infection Microbiology in April 2021, describes how “syphilis serology is imperfect and requires interpreta- tion of multiple tests while molecular diagnostics allows for potential yes-no identification of highly infective, primary anogenital lesions.” 8 The researchers performed a retro-
spective analysis of adult patients with anogenital lesions who were screened for syphilis and herpes simplex (HSV) 1/2 in Alberta, Canada using polymerase chain reaction (PCR) to evaluate Tp-PCR versus serology to diagnose primary syphilis. The researchers concluded that “mo-
lecular testing using Tp-PCR for primary syphilis appears to be a highly specific test with low sensitivity that is, therefore, most useful in confirming the diagnosis rather than as a screening test.” They added, “Concurrent testing with syphilis serol- ogy remains necessary to ensure all cases are identified to manage the worsening
MLO-ONLINE.COM JUNE 2022 37
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52
