Linear array hpv test

Manufactured by Roche

Sourced in United States

The Linear Array HPV Test is a molecular diagnostic tool designed to detect and identify human papillomavirus (HPV) genotypes. The test utilizes a linear array format to provide qualitative detection of multiple HPV types from a single patient sample.

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Lab products found in correlation

Magna pure compact nucleic acid isolation kit, by Roche (1 mentions) Linear array hpv genotyping test, by Roche (1 mentions)

4 protocols using linear array hpv test

Self-Sampling for HPV Genotyping

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For self-sampling, patients were instructed to insert a Dacron swab high into the vagina and twirl it for 10 seconds. Self-sampling was conducted in private. Samples were stored in Digene transport medium and DNA was extracted using the MagNA Pure Compact Nucleic Acid Isolation Kit (Roche Diagnostics). HPV genotyping was conducted using Roche's Linear Array HPV Test. This kit detects 37 HPV genotypes [14 (link)] including all oncogenic HPV types identified by the International Agency for Research on Cancer (IARC) [15 (link)]. We defined HR-HPV to include 13 genotypes designated by IARC to have sufficient evidence to cause cervical cancer (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59) and to have strong mechanistic evidence for cervical cancer (type 68) [15 (link)].
Pap smear results were reported in accordance with the Bethesda system [16 (link)]. All positive Pap smears that were identified by cytotechnologists were sent for review by a pathologist. Women with incidentally identified infections on Pap smear (e.g., Trichomonas) were referred for appropriate treatment. Most recent CD4 test results were obtained from the local government clinic where HIV-infected participants receive care.

Adler D.H., Wallace M., Bennie T., Mrubata M., Abar B., Meiring T.L., Williamson A.L, & Bekker L.G. (2014). Cervical Dysplasia and High-Risk Human Papillomavirus Infections among HIV-Infected and HIV-Uninfected Adolescent Females in South Africa. Infectious Diseases in Obstetrics and Gynecology, 2014, 498048.

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Identification of HPV Genotypes using Linear Array

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Type-specific identification of HPV genotypes was performed using the Linear Array technique (Roche Molecular Systems) according to the manufacturer's instructions. This technique allows the identification of 37 HPV genotypes, including 14 HR genotypes (i.e. 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 , 66, and 68) and 23 LR viral types (i.e. 6, 11, 26, 40, 42, 53, 54, 55, 61, 62, 64, 67, 69, 70, 71, 72, 73, 81, 82, 83 , 84, IS39, and CP6108), which are widely used in epidemiological studies. The Linear Array HPV test (Roche Molecular Systems) has 96% sensitivity and 99% specificity to detect DNA from HR HPV types (Linear Array HPV Genotyping Test ® ; Roche). Extraction, amplification, and hybridization steps allow identification of both the target viral genetic material and a fragment of the human β-globin gene, used as the internal control in sample processing.

Vargas H., Sánchez J.P., Guerrero M.L., Ortiz L.T., Rodríguez D.M., Amaya J., Diaz L.P., Gómez S.L, & Golijow C. (2016). Type-Specific Identification of Genital Human Papillomavirus Infection in Women with Cytological Abnormality. Acta cytologica, 60(3).

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Cervical Cancer Screening Protocol

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Client demographics were either self-collected by literate clients in the reception area or collected with help of the clinic staff for clients unable to read or write. Clinical data, including previous cervical cancer screening uptake and whether HIV-positive clients were newly diagnosed or already knew their status, were collected by the study counsellors and nurse. All data were collected through questionnaires and screening results and recorded directly onto paper forms comprising the PHRU HTS client file. The data were then captured in the study’s electronic database, REDCap. Source documents included the HTS client file and pathology reports, which were printed and filed within the HTS client file. Results from HPV genotyping via Roche Linear Array HPV test and Pap smear liquid based cytology (both analyses conducted using a single swab specimen) were emailed from the Bio Analytical Research Corporation South Africa PTY (LTD), Central Laboratory for Clinical Trials.

Hopkins K.L., Jaffer M., Hlongwane K.E., Otwombe K., Dietrich J., Cheyip M., Olivier J., Doherty T, & Gray G.E. (2021). Assessing national cervical cancer screening guidelines: Results from an HIV testing clinic also screening for cervical cancer and HPV in Soweto, South Africa. PLoS ONE, 16(7), e0255124.

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HPV Genotypes and Cervical Neoplasia

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We collected 147 cervical brushings from patients from the Gynecologic Committee of the Taiwan Cooperative Oncology Group (TCOG) cohorts [12 (link)] who were infected with HPV and who were diagnosed as normal (n=28), with CIN1 (n=45), CIN2 (n=13), and CIN3/carcinoma in situ (CIS, n=61). Cytological, histological, and clinical data for all patients were reviewed by a panel of colposcopists, cytologists, and pathologists. The patients' final diagnosis was reported as the most severe grade of abnormality identified in punch or cone biopsy specimens. Including criteria were patients aged ≥20 years and enrolled from December 2009 to November 2010. Exclusion criteria were pregnancy, chronic or acute systemic viral infections, a history of cervical neoplasia, skin or genital warts, an immune-compromised state, the presence of other cancers, or a history of surgery to the uterine cervix. The infecting HPV types included 16, 18, 52, and 58. The HPV genotype was determined by reverse line blot hybridization (the prototype Roche linear array HPV test; Roche Molecular Systems Inc., Pleasanton, CA, USA) and consensus polymerase chain reaction (PCR) of the L1 sequences. The demographic details of patients are listed in Supplementary Table 1. Informed consent was obtained from all patients, and this study was approved by the Institutional Review Boards of all participating medical centers.

Hsu Y.W., Huang R.L., Su P.H., Chen Y.C., Wang H.C., Liao C.C, & Lai H.C. (2017). Genotype-specific methylation of HPV in cervical intraepithelial neoplasia. Journal of Gynecologic Oncology, 28(4), e56.

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