MOLECULAR DIAGNOSIS OF INFECTION

GenePro's Tests
Human Papilloma Virus (HPV)

Specimen

Hepatitis B Virus (HBV)

Hepatitis C Virus (HCV)

Herpes simplex I & II

Varicella Zoster Virus
(VZV, Shingles)

Epstein Barr Virus (EBV)

Chlamydia trichomatis (CT)

Neisseria gonorrhea (NG)

Mycoplasma genitalium & hominis (MG, MH)

Ureaplasma urealyticum (UU)

Mycobacterium tuberculosis
(TB complex)

Coming soon!
Hepatitis A Virus (HAV)
Hepatitis D Virus (HDV)
Hepatitis E Virus (HEV)

　Molecular Diagnosis of Infection > Specimen and Report

　Samples for DNA Testing of Infectious Microorganisms

Test	Sample	Requirement*	Method**	Report**
Human Papilloma Virus (HPV) DNA	Liquid cytology		PCR qPCR RFLP	Negative, Not detected Positive, genotype(s) Positive, specific genotype(s) unknown, multiple infection
	ThinPrep	4 ml, r.t. or 4°C
	SurePath (Autocyte)	4 ml, r.t. or 4°C
	Cervical/vaginal swab	1 swab, 4°C
	Urethral swab	1 swab, 4°C
	Topical swab	1 pre-wet swab, 4°C
	Urine	20 ml, first void
	Tampon/vaginal insert	1 set, 4°C/frozen
Hepatitis B Virus (HBV) DNA	Clotted blood	2 ml, less than 6 hr at 4°C	qPCR	Negative, Not detected Positive but below limit of detection Positive, copies & IU/ml
	EDTA blood	2 ml, less than 6 hr at 4°C
	Plasma	1 ml, 4°C or frozen
	Serum	1 ml, 4°C or frozen
Hepatitis C Virus (HCV) RNA	EDTA blood	2 ml, less than 6 hr at r.t. or 4°C	RT-qPCR	Negative, Not detected Positive but below limit of detection Positive, copies/ml
	Plasma	1 ml, 4°C or frozen
	Serum	1 ml, 4°C or frozen
Epstein Barr Virus (EBV) DNA	EDTA blood Plasma Serum	2 ml, less than 6 hr at 4°C 1 ml, 4°C or frozen	qPCR	Negative, Not detected Positive, copies/ml or sample
Epstein Barr Virus (EBV) DNA	Nasal swab	1, 4°C or frozen	qPCR	Negative, Not detected Positive, copies/ml or sample
Herpes Simplex Virus (HSV) I & II DNA	Liquid cytology		qPCR	Negative, Not detected Positive Type I and/or II
	ThinPrep	4 ml, r.t. or 4°C
	SurePath (Autocyte)	4 ml, r.t. or 4°C
	Cervical/vaginal swab	1 swab, 4°C
	Urethral swab	1 swab, 4°C
	Topical swab	1 pre-wet swab, 4°C
	CSF	0.5 ml, 4°C /frozen
	Tampon/vaginal insert	1 set, 4°C/frozen
Varicella Zoster Virus (VZV, Shingles) DNA	Topical swab	1 pre-wet swab, 4°C	qPCR	Negative, Not detected Positive
	CSF	0.5 ml, 4°C /frozen


Chlamydia trichomatis (CT) DNA	Liquid cytology		qPCR	Negative, Not detected Positive
	ThinPrep	4 ml, r.t. or 4°C
	SurePath (Autocyte)	4 ml, r.t. or 4°C
	Cervical/vaginal swab	1 swab, 4°C
	Urethral swab	1 swab, 4°C
	Topical swab	1 pre-wet swab, 4°C
	Urine	20 ml, first void
	Tampon/vaginal insert	1 set, 4°C/frozen
Neisseria gonorrhea (NG) DNA	Liquid cytology		qPCR	Negative, Not detected Positive
	ThinPrep	4 ml, r.t. or 4°C
	SurePath (Autocyte)	4 ml, r.t. or 4°C
	Cervical/vaginal swab	1 swab, 4°C
	Urethral swab	1 swab, 4°C
	Topical swab	1 pre-wet swab, 4°C
	Urine	20 ml, first void
	Tampon/vaginal insert	1 set, 4°C/frozen
Mycoplasma genitalium (MG) Mycoplasma hominis (MH) DNA	Liquid cytology		qPCR	Negative, Not detected Positive genitarium and/or hominis
	ThinPrep	4 ml, r.t. or 4°C
	SurePath (Autocyte)	4 ml, r.t. or 4°C
	Cervical/vaginal swab	1 swab, 4°C
	Urethral swab	1 swab, 4°C
	Topical swab	1 pre-wet swab, 4°C
	Urine	20 ml, first void
	Tampon/vaginal insert	1 set, 4°C/frozen
Ureaplasma urealyticum parvum; Ureaplasma urealyticum T-960 (UU) DNA	Liquid cytology		qPCR	Negative, Not detected Positive parvum and/or T-960
	ThinPrep	4 ml, r.t. or 4°C
	SurePath (Autocyte)	4 ml, r.t. or 4°C
	Cervical/vaginal swab	1 swab, 4°C
	Urethral swab	1 swab, 4°C
	Topical swab	1 pre-wet swab, 4°C
	Urine	20 ml, first void
	Tampon/vaginal insert	1 set, 4°C/frozen
Mycobacterium tuberculosis (TB) (MTb complex) DNA	Sputum	First in morning	qPCR	Negative, Not detected Positive, copies/sample Positive but below limit of detection
	Urine	20 ml, first void
	Needle biopsy
	Environmental sample

*	Requirement
	r.t. = room temperature; fridge = 4-8oC (household refrigerator, lower compartment) frozen = -10oC or less (household freezer, upper compartment) ThinPrep and SurePath cell suspensions are stable > 2 weeks for cytology at room temperature. But do not keep them for more than 3 days for DNA testing because it might affect the typing of high risk HPV types; keeping at 4oC or frozen is recommended.
**	Method
	Requirements of CLIA: E.M. Burd (2010). “Validation of Laboratory-Developed Molecular Assays for Infectious Diseases” Clinical Microbiology Reviews, July 2010, p. 550-576 qPCR = real time PCR, quantitative PCR; RT-qPCR = reverse transcription qPCR; RFLP = restriction fragment length polymorphism

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