Methods and devices for nasopharyngeal carcinoma screening

Abstract

Methods and devices for nasopharyngeal carcinoma screening are disclosed. The method comprises providing a nasopharyngeal sample from a subject, isolating DNA from the sample, amplifying and detecting at least one EBV target sequence from the DNA using real-time PCR, wherein a real time PCR cycle threshold number of less than or equal to 31.5 is indicative of the subject having nasopharyngeal carcinoma or a risk of developing nasopharyngeal carcinoma.

1 - 10 . (canceled) 
     
     
         11 . A device for obtaining a brush biopsy sample comprising a longitudinal shaft having a first end and a second end, wherein at least two brush heads extend from the second end of the shaft. 
     
     
         12 . The device of  claim 11 , wherein the at least two brush heads comprise a contact region connected to a brush shaft, the brush shaft extending from the second end of the shaft. 
     
     
         13 . The device of  claim 12 , wherein the contact region comprises a sample collection surface, the sample surface optionally comprising a bristled surface, a serrated surface, a honey comb surface, a saw tooth surface or a porous surface. 
     
     
         14 . (canceled) 
     
     
         15 . The device of  claim 11 , wherein the at least two brush heads are connected to the second end of the shaft through a neck region, wherein the neck region optionally extends at an angle of 0 to 90 degrees, optionally about 65 to 75 degrees, to the longitudinal axis of the shaft and wherein the brush heads optionally extend from the neck region at an angle of 0 to 90 degrees, optionally about 65 to 75 degrees. 
     
     
         16 .- 18 . (canceled) 
     
     
         19 . The device of  claim 11 , wherein the two brush heads are parallel to each other. 
     
     
         20 - 25 . (canceled) 
     
     
         26 . The device of  claim 11 , wherein the shaft is 5 to 30 cm in length or optionally about 13 to 19 cm in length. 
     
     
         27 . A device for obtaining a brush biopsy sample comprising a longitudinal shaft having a first end and a second end and at least one brush head extending from the second end of the shaft,
 wherein the at least one brush head is moveable between a first uninflated position and a second inflated position.   
     
     
         28 . The device of  claim 27 , wherein the brush head is unelongated in the first uninflated position and elongated in the second inflated position, optionally wherein the brush head is 1 to 10 centimeters longer in the second elongated position than in the first unelongated position. 
     
     
         29 . (canceled) 
     
     
         30 . The device of  claim 27 , wherein the brush head comprises an inflatable contact region and a brush shaft. 
     
     
         31 . The device of  claim 30 , wherein the contact region comprises a sample collection surface for providing a biopsy sample, optionally wherein the contact region comprises a sample collection surface for providing a biopsy sample. 
     
     
         32 . (canceled) 
     
     
         33 . (canceled) 
     
     
         34 . The device of  claim 31 , wherein the sample collection surface comprises bristled surface, a brush surface, a serrated surface, a honey comb surface a saw tooth surface or a porous surface. 
     
     
         35 . The device of  claim 27 , wherein the shaft comprises a means for inflating the brush head. 
     
     
         36 . The device of  claim 27 , wherein the shaft is connected to a handle, the handle comprising a means for inflating the brush head. 
     
     
         37 . The device of  claim 36 , herein the handle is detachable from the shaft. 
     
     
         38 . The device of  11 , wherein the device comprises a handle extending from the first end of the shaft, the handle comprising a light. 
     
     
         39 . The device of  claim 38 , wherein the light is oriented to provide illumination along the longitudinal axis of the shaft. 
     
     
         40 . The device of  claim 38 , wherein the handle is detachable from the shaft. 
     
     
         41 . (canceled) 
     
     
         42 . A method of providing a nasopharyngeal sample from a subject, the method comprising contacting the nasopharynx of a subject with the device of  claim 11 . 
     
     
         43 . The method of  claim 42 , wherein the method is performed transorally. 
     
     
         44 . A method of providing an oral, oropharynx or hypopharynx sample from a subject, the method comprising contacting the oral cavity, oropharynx or hypopharynx of a subject with the device of  claim 11 .