1600 Scripture Street Denton, TX (940) 384-6280

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Chlamydia (CT) Gonorrhoeae (GC) HPV Low Risk (LR) 1600 SCRIPTURE STREET · DENTON, TX · (940) 384-6280 HPV High Risk (HR) HPV Genotyping 16/18 Herpes Simplex Virus 1 Herpes Simplex Virus 2 Vaginosis Profile: Candida Interpretation of Molecular Test Results Gardnerella TEST NEGATIVE EQUIVOCAL POSITIVE Trichomonas Interpretation of Molecular Test Results

RESULTS TEST a Negative i d Positive y

m By the HC2 method, this

a A NEGATIVE result does not specimen is considered Indeterminate l Test results with RLU/cutoff ratios

h preclude Chlamydia trachomatis “POSITIVE for Chlamydia ≥ 1.0 and ≤ 2.50 are EQUIVOCAL Equivocal C or Neisseria gonorrhoeae trachomatis or POSITIVE for

e and may be considered infection because results depend Neisseria gonorrhoeae DNA.” a presumptively positive. It is

e on adequate specimen collection Organism viability and/or recommended to repeat testing o and sufficient DNA to be infectivity cannot be inferred

h with a new specimen. detected. since DNA may persist in the r

COMMENTS r absence of viable organisms. o

Low Volume n o

QNS G TEST NEGATIVE INDETERMINATE POSITIVE R L

The HC2 HPV DNA Test is The HC2 LR HPV DNA Test is The HC2 HPV DNA Test is

V NEGATIVE but does not exclude POSITIVE for one or more virus INDETERMINATE since the ratio

P the possibility of HPV infection types 6, 11, 42, 43, and 44. between the relative light units and

H because of very low levels of the positive cutoff is >1.0 and <2.5.

R infection, sampling error, high The HC2 HR HPV DNA Test is Upon completion of re-testing, if

H concentrations of anti-fungal POSITIVE for one or more virus possible, a FINAL report will be cream, contraceptive jelly, or types 16, 18, 31, 33, 35, 39, 45, 51, V issued. douche. 52, 56, 58, 59, and 68. P H 8 V 1 The 16/18 HPV DNA Test is The 16/18 HPV DNA Test is / P Unable to report due to low sample

6 NEGATIVE for virus types POSITIVE for virus types H

1 cellularity or invalid result. 16 and 18. 16 and/or 18. Updated 5/24/2011

TEST NEGATIVE POSITIVE V S This specimen is considered to be NEGATIVE for This specimen is considered to be POSITIVE for H HSV 1 or HSV 2 by PCR. HSV 1 or HSV 2 is not HSV 1 or HSV 2 by PCR. HSV 1 or HSV 2 is detected 2 detected at < 10 copies/mL. at ≥ 10 copies/mL. &

s i TEST NEGATIVE POSITIVE s o n i TEST g

a A POSITIVE result means that nucleic acid for

V Candida This specimen is considered to be Candida sp. (C. albicans, C. glabrata, C. kefyr, C. e

l NEGATIVE for Candida sp., krusei, C. parapsilosis, C. tropicalis), Gardnerella i

f Gardnerella Gardnerella, or Trichomonas, when vaginalis, and/or Trichomonas vaginalis is present o consistent with signs and symptoms. A in the sample and indicates the patient has r P Trichomona s negative result indicates nucleic acid candidiasis, bacterial vaginosis, and/or from less than 1x104 Candida cells, 2x105 trichomoniasis when consistent with clinical signs CFU of Gardnerella, or 5x103 and symptoms. Simultaneous infections by more COMMENT: Low Volume Specimens consisting of less than the optimal specimen volume (4 ml) may cause false negative results. Please resubmit a Cervical Sampler specimen if clinically indicated and/or feasible. COMMENT: QNS Quantity Not Sufficient: the specimen contained an INSUFFICIENT VOLUME FOR PROCESSING. The minimum volume of PreservCyt solution necessary to perform testing is 4.0 ml. The current specimen was less than 1.0 ml. Please resubmit a Cervical Sampler specimen (or PreservCyt specimen) for testing. The Cervical Sampler is the preferable specimen as it negates the FDA retesting in the “gray zone”. Please plainly mark desired testing (for example: HPV TESTING ONLY – NO PAP SMEAR) on the requisition.