Sample collection for the diagnostic of infectious diseases .

The DNA Genotek OMNIgene ORAL or Colli-Pee® kits are easy to handle and therefore also ideally suited for home use. Since the DNA and RNA remain stable in the tube up to +50°C, no cold chain is required.

Hard Facts .

Applications .

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Accordion Content

P. falciparum and P. vivax detection

OMNIgene ORAL products provide a painless, non-invasive alternative to blood collection for the detection of circulating Plasmodium falciparum or P. vivax parasites.

Okumu, W., Okeyo, W. A., Munde, E. O., Raballah, E., Anyona, S. B., & Ouma, C. (2015). Evaluation of saliva-derived Plasmodium falciparum DNA using the OMNIgene®-ORAL kit in detection of malaria. DNA Genotek https://www.dnagenotek.com/ROW/pdf/PD-WP-00035.pdf

Visanuvimol, D. (2014). Saliva as a proven, non-invasive sample type for molecular malaria testing and surveillance using OMNIgene®-ORAL at ambient temperatures. DNA Genotek https://www.dnagenotek.com/ROW/pdf/PD-WP-00041.pdf

SARS-CoV-2 detection

The gold standard for detecting SARS-CoV-2 infection is the detection of viral RNA in saliva samples or oral, pharyngeal, and nasal swabs by PCR/qPCR. The OMNIgene ORAL Kit OME-505 stabilizes SARS-CoV-2 RNA in collected saliva samples over several weeks at room temperature and allows home sample collection.

DNA Genotek. (2020). Inactivation of SARS-CoV-2 in samples collected using Oragene®, ORAcollect® and OMNIgene® products from DNA ^GenotekTM. https://www.dnagenotek.com/ROW/pdf/MK-01430.pdf

Colameco, S., Brown, A., & Crawford Parks, T. (2020). Ambient temperature stabilization of SARS-CoV-2 viral RNA in OMNIgene®-ORAL (OME-505) collected saliva samples. DNA Genotek https://www.dnagenotek.com/ROW/pdf/PD-WP-00069.pdf

Detection of viral DNA/RNA

Stabilization of viral DNA and RNA after sample collection is important to obtain results of consistent quality and to avoid bias. The OME-505 kit (formerly OM-505) allows long storage time of up to three weeks at room temperature without loss of DNA or RNA quality.

DNA Genotek. (2015). OMNIgene®-ORAL (OM-505) stabilizes RNA from human viruses at room temperature for several weeks. https://www.dnagenotek.com/ROW/pdf/PD-WP-00024.pdf

Doukhanine, E., & Merino, C. (2020). Stability, recovery efficiency and detection limit of viral DNA in OMNIgene®-ORAL (OM-505). DNA Genotek https://www.dnagenotek.com/ROW/pdf/PD-WP-00028.pdf

HPV-based cervical cancer screening

Molecular detection of human papillomavirus (HPV) DNA in urine is suitable for screening for cervical precancerous lesions. ^Colli-Pee® enables user-friendly self-collection of urine, eliminating the need for cervical swabs for cytological analysis.

Mehta, A., Laeremans, M., Meers, N., Ríos Cortés, A., Van Avondt, Q., Pasmans, D., Beyers, K., & Vankerckhoven, V. (2021). First-void urine as a game-changer for HPV-based cervical cancer screening. Novosanis. Link

Laeremans, M., Mehta, A., Pasmans, D., Jordaens, S., Faster, D., Beyers, K., & Vankerckhoven, V. (2021). HPV-based cervical cancer screening: gaining insights into sample preference and cost-effectiveness. DNA Genotek Link

Pasmans, D., Mehta, A., Bruyninckx, S., Hendrickx, J., Beyers, K., & Vankerckhoven, V. (2021). Molecular-based triage on hrHPV-positive women to detect cervical cancer. DNA Genotek Link

STI detection

First urine is suitable for detecting pathogen DNA of sexually transmitted infectious diseases (STIs), including human papillomavirus (HPV) and Chlamydia trachomatis (CT).

Mehta, A., Pasmans, D., Vankerckhoven, V., & Beyers, K. (2021). Urine collected through Colli-Pee offers potential for self-sampling at home for detection of sexually transmitted infections. Novosanis. Link

Details .

Various kits for sampling .

	OME-505	ORE-100	OM-501	Colli-Pee®
Nucleic acid	DNA and RNA	RNA	DNA	DNA
Collection site	Saliva	Oral cavity	Saliva	Urine
Stability	3 weeks	60 days	1 year	< 14 days at RT
Swab-based		✔
CE-IVD certified	✔	✔		✔

[1] Colli-Pee and urine stability; https://novosanis.com/sampling-solutions/colli-pee-urine-stability

OME-505 .

OMNIgene ORAL OME-505 is perfect for the collection and stabilization of microbial nucleic acids. The kit provides excellent sample integrity and stabilization. This is essential to exclude bias when analyzing the microbiome using microarrays or next generation sequencing.

Advantages .

CE/IVD certified
Easy self-collection of high-quality DNA and RNA from oral samples
Stabilizes samples from collection to analysis of DNA and RNA - no refrigerated transport necessary
Snapshot of the microbial profile at the time of sampling.
Allows simultaneous detection of DNA and RNA of bacteria and viruses from a single sample
Reduces transport and storage costs and process complexity due to 3 weeks of room temperature stability of DNA and RNA
Allows identification of live or metabolically active bacteria at the time of collection by RNA expression profiling
Tube format is suitable for high-throughput analysis, increases efficiency and minimizes sample handling errors
Compatible with downstream applications (e.g. RT-qPCR, microarray)

Application	Target	Reference
Virus	DNA	EBV [1], HHV-8 [2,3], CMV [4]
	RNA	HCV [5], HIV [5,6]
Bacteria	DNA	HOMIM [7]
	RNA	E. coli [9]
Extraction systems		Abbott m2000 [5,6], Qiagen MinElute [8]
Downstream applications		qPCR [1,2,3], Microarray [7]

[1] Stability, recovery efficiency and detection limit of human viral DNA in OMNIgene®•ORAL (OM-505). DNA Genotek. PD-WP-00028.
[2] High quality microbial DNA collected with OMNIgene•ORAL enables detection of HHV-8 in saliva. DNA Genotek. MK-00018.
[3] Evaluation of a new commercial kit for detection of human herpesvirus 8 (HHV-8) in saliva. http://www.dnagenotek.com/ROW/pdf/GriffithUniversity.pdf
[4] Genotyping of cytomegalovirus from toddlers’ saliva samples collected with OMNIgene•ORAL. DNA Genotek. MK-00050.
[5] Compatibility of saliva collected using OMNIgene•ORAL (OM-505) with the Abbott m2000rt RealTime System for the detection of viral RNA. DNA Genotek. PD-WP-00025.
[6] OMNIgene•ORAL (OM-505) stabilizes RNA from human viruses at room temperature for several weeks. DNA Genotek. PD-WP-00024.
[7] OMNIgene•ORAL stabilizes microbial DNA profiles in oral fluid samples, enables more precise characterization of oral flora. DNA Genotek. MK-00090.
[8] OM-505 Microbial DNA and RNA purification protocol using QIAGEN® QIAamp® MinElute Virus Spin Kit. DNA Genotek. PD-PR-00214.
[9] Internal validation using OM-505 extraction8 in house RT-qPCR.

More information .

Manufacturer website
Manufacturer website

Instruction manual (engl.)
Instruction manual (engl.)

SARS-CoV-2 RNA detection from saliva .

To determine whether SARS-CoV-2 RNA can be reliably detected in saliva samples collected with OMNIgene-ORAL (OME-505) stored at room temperature, stability tests were performed on samples from 15 participants using an internally verified RUO assay optimized for the detection of SARS-CoV-2 RNA in saliva. Samples were spiked with heat-inactivated SARS-CoV-2 at two different concentrations depicting a low viral spike (500 cp/mL) and a high viral spike (2,500 cp/mL). Samples were stored at room temperature (23 ± 3°C) for 21 days and extracted at baseline and at the 7 and 21 day time points. The SARS-CoV-2 nucleocapsid gene (N1 and N2) was used to detect the stability of viral RNA by RT-qPCR. Samples with a cq value of <40 had detectable viral RNA. The human RNase P gene (RP) was included as a control for human nucleic acid detection.

Cq values for SARS-CoV-2 RT-qPCR targets N1, N2 (viral), and RNase P (human, RP) at day 0 (purple), day 7 (blue), and day 21 (orange) in low-positive (500 cp/ml, N = 15) and high-positive (2,500 cp/ml, N = 14) enriched saliva samples. The dotted line indicates the detection limit. If no amplification was detected, the cq was set to 45 (maximum cq) for visualization. Statistical significance was determined using a two-way ANOVA with Sidak test for multiple comparisons.

From: Colameco, S., Brown, A., & Crawford Parks, T. (2020). Ambient temperature stabilization of SARS-CoV-2 viral RNA in OMNIgene®-ORAL (OME-505) collected saliva samples. DNA Genotek https://www.dnagenotek.com/ROW/pdf/PD-WP-00069.pdf

ORE-100 .

Every expression analysis starts with the collection of RNA samples. ORAcollect® RNA (ORE-100) is an all-in-one system for the collection, stabilization and transport of RNA from saliva for in vitro diagnostics.

Advantages .

Stabilizes samples during collection and ensures that DNA and RNA are unchanged at the time of processing
Stabilizes human, viral and bacterial RNA from saliva at room temperature
Reduces transportation and storage costs and complexity with up to 60 days stability of RNA at room temperature
Easy self-collection of high-quality DNA and RNA from oral samples
No refrigerated transports necessary
Compatible with downstream applications (e.g. RT-qPCR, microarray)
Format suitable for high throughput processing

More information .

Manufacturer website
Manufacturer website

Instruction manual (engl.)
Instruction manual (engl.)

OM-501 .

The OMNIgene ORAL OM-501 kit enables the collection of high-quality samples for the molecular detection of microbial DNA. Samples are preserved well enough to avoid bias until analysis by microarrays or next generation sequencing.

Advantages .

Improved patient compliance through painless, non-invasive specimen collection
Increases specimen handling efficiency and reduces handling errors
Ideal for on-site collection, transport at room temperature and long-term storage
The sample remains stable for one year at room temperature, which reduces the cost and effort of transport and storage
Format suitable for high throughput automated processing

	Venous blood	Mouthwash	Buccal swabs	OMNIgene•ORAL (OM-501)
Non-invasive collextion	✘	✘	✔	✔
Standardized format for high-throughput processing	✔	✘	✘	✔
Specimen stability at room temperature	Days	Weeks	Days	1 year
	Blood collection	Oral collection

More information .

Manufacturer website
Manufacturer website

Instruction manual (engl.)
Instruction manual (engl.)

Colli-Pee® FV-5000 .

Colli-Pee® is a patented sampling device that allows volumetric and standardized collection of morning urine. The product range consists of variants that collect different volumes from 4 to 45 mL. The collection tubes can be pre-filled with a preservative, allowing for longer storage and/or shipment of urine at room temperature.

First urine contains higher concentrations of analytes associated with various sexually transmitted infections, including human papillomavirus (HPV) and Chlamydia trachomatis (CT) DNA. In addition, the collection of urine samples from the morning first stream is important for the identification of cancer biomarkers, e.g., for prostate cancer.

Manufacturer website
Manufacturer website

Instruction manual (engl.)
Instruction manual (engl.)

Publications
Publications

Specimen collection for infectious diseases .

DNA and RNA Sample collection from saliva or urine.

OM-501

Downloads .

Fact Sheets

Manuals

Safety Data Sheets

White Paper

Storage and transport

Protocols

Fact Sheets

Manuals

Safety Data Sheets

White Paper

Storage and transport

Protocols

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Sample collection for the diagnostic of infectious diseases .

Hard Facts .

Applications .

Details .

Various kits for sampling .

Specimen collection for infectious diseases .

Saliva Self Collection Kit; Microbiome – OM-501

Saliva Self Collection Kit; DNA/RNA – OME-505

RNA Self Collection Kit – ORE-100

Downloads .

DNA Genotek – Mikrobiome and Metabolomics Kits – Overview 478.42 KB

OMNIgene ORAL – OM-501 – Fact Sheet 0.00 KB

OMNIgene ORAL – OME-505 – Fact Sheet 0.00 KB

OMNIgene ORAL – OMR-120 – Fact Sheet 0.00 KB

OMNIGene SALIVA DNA and RNA – OMR-610 – Fact Sheet 1.29 MB

ORAcollect RNA – ORE-100 – Fact Sheet 0.00 KB

OMNIgene ORAL – OM-501 – Manual 0.00 KB

OMNIgene ORAL – OME-505 – Manual 0.00 KB

OMNIgene ORAL – OMR-110 – Fact Sheet 0.00 KB

OMNIgene ORAL – OMR-110 – Manual 0.00 KB

OMNIgene ORAL – OMR-120 – Manual 0.00 KB

OMNIGene SALIVA DNA and RNA – OMR-610 – Manual 0.00 KB

ORAcollect RNA – ORE-100 – Manual 0.00 KB

OMNIgene ORAL- OME-505 – Safety Data Sheet 0.00 KB

OMNIgene ORAL – OMR-110 / OMR-120 – Safety Data Sheet 0.00 KB

OMNIGene SALIVA DNA and RNA – OMR-610 – Safety Data Sheet 0.00 KB

ORAcollect RNA – ORE-100 – Safety Data Sheet 0.00 KB

PD-WP-005: Long-term stability of DNA from saliva samples stored in the Oragene® self-collection kit 0.00 KB

PD-WP-012: Comparison of DNA yield from Oragene/saliva and blood samples 0.00 KB

PD-WP-00069: OMNIgene•ORAL (OME-505) white paper 0.00 KB

MK-00018: Case Study: High quality microbial DNA collected with OMNIgene•ORAL enables detection of HHV-8 in saliva 0.00 KB

MK-00050: Case Study: Genotyping of cytomegalovirus from toddlers’ saliva samples collected with OMNIgene™•ORAL 0.00 KB

MK-00246: DNA from saliva is a reliable sample type for malaria detection 0.00 KB

PD-WP-00041: Saliva as a proven, non-invasive sample type for molecular malaria testing and surveillance using OMNIgene®•ORAL at ambient temperatures 0.00 KB

PD-WP-00035: Evaluation of saliva-derived Plasmodium falciparum DNA using the OMNIgene®•ORAL kit in detection of malaria 0.00 KB

DNA Genotek – Mikrobiome and Metabolomics Kits – Overview 478.42 KB

OMNIGene SALIVA DNA and RNA – OMR-610 – Fact Sheet 1.29 MB

OMNIgene SKIN – OMR-140 – Fact Sheet 0.00 KB

OMNIgene VAGINAL – OMR-130 – Fact Sheet 0.00 KB

Storage recommendations for samples collected with OMNIgene® products 0.00 KB

PD-PR-012: Long-term storage of Oragene®/saliva samples 0.00 KB

OMNIgene ORAL – OM-501 / OME-505 – Protokoll 0.00 KB