Hadarin da ke Haɗe da Gwaje-gwajen Haɓaka Haɓaka

A yau, Hukumar Kula da Abinci da Magunguna ta Amurka tana gargaɗin jama'a game da haɗarin sakamakon ƙarya, rashin amfani da rashin dacewa da fassarar sakamakon da bai dace ba tare da gwaje-gwajen gwajin da ba su da ƙarfi (NIPS), wanda kuma ake kira gwajin DNA maras tantanin halitta ko kuma gwaje-gwajen da ba na cin zarafi ba. (NIPT). Wadannan gwaje-gwajen suna neman alamun rashin daidaituwa na kwayoyin halitta a cikin tayin ta hanyar gwada samfurin jini daga mai ciki. Ganin karuwar amfani da waɗannan gwaje-gwaje da rahotannin kafofin watsa labaru na baya-bayan nan, FDA tana ba da wannan bayanin don ilmantar da marasa lafiya da masu ba da kiwon lafiya da kuma taimakawa wajen rage rashin dacewa na gwajin NIPS.

"Yayin da ake amfani da gwaje-gwajen gwaje-gwajen gwaje-gwajen da ba su da haɗari a yau, waɗannan gwaje-gwajen ba su sake nazarin su ta hanyar FDA ba kuma suna iya yin da'awar game da aikin su da kuma amfani da su ba bisa ga kimiyya mai kyau ba," in ji Jeff Shuren, MD, JD, darektan Cibiyar Na'urori da Lafiyar Radiyo na FDA. "Ba tare da fahimtar yadda ya kamata a yi amfani da waɗannan gwaje-gwajen ba, mutane na iya yanke shawarar kula da lafiyar da ba ta dace ba game da ciki. Muna kira ga marasa lafiya da su tattauna fa'idodi da kasadar waɗannan gwaje-gwaje tare da mai ba da shawara kan kwayoyin halitta ko wasu masu ba da lafiya kafin yanke shawara kan sakamakon waɗannan gwaje-gwajen."

Gwajin NIPS na iya ba da bayani game da yuwuwar za a haifi yaro tare da mummunan yanayin lafiya. Koyaya, gwaje-gwajen NIPS gwaje-gwaje ne na nunawa - ba gwaje-gwajen bincike ba. Suna ba da bayani ne kawai game da haɗarin cewa tayin na iya samun rashin daidaituwa na kwayoyin halitta, kuma ana iya buƙatar ƙarin gwaji don tabbatar da ko tayin ya shafa.

Ana iya haifar da rashin daidaituwar kwayoyin halitta ta hanyar chromosome da ya ɓace ko ƙarin kwafin chromosome, wanda aka sani da aneuploidy, ƙaramin yanki da ya ɓace daga chromosome da ake kira microdeletion, ko wani karin guntu na chromosome da ake kira kwafi. Wadannan rashin daidaituwa na kwayoyin halitta na iya haifar da mummunan yanayin lafiya. Abubuwan da ke haifar da ɓacewar chromosome ko ƙarin kwafin chromosome sun fi yawa kuma yana iya zama sauƙin ganewa, kamar Down syndrome, wanda zai iya haifar da ƙalubale na jiki da na hankali. Race ko ƙarin yanki na chromosome na iya haifar da yanayi da ba kasafai ba, kamar ciwon DiGeorge, wanda zai iya haifar da lahani na zuciya, wahalar ciyarwa, matsalolin tsarin rigakafi da matsalolin koyo.

Duk gwaje-gwajen NIPS akan kasuwa a yau ana bayarwa azaman gwajin haɓakar dakin gwaje-gwaje (LDTs). Yawancin LDTs, gami da gwaje-gwajen NIPS, ana bayarwa ba tare da bita ta FDA ba. Yayin da LDTs ​​na'urorin likitanci ne a ƙarƙashin Dokar Abinci, Drug, da Cosmetic ta Tarayya, FDA tana da babban manufar aiwatar da hankali ga mafi yawan LDT tun lokacin da aka aiwatar da gyare-gyaren Na'urar Likita a cikin 1976. Wannan yana nufin cewa FDA ba ta cika aiwatar da buƙatun ƙa'ida ba. don yawancin LDTs. FDA tana ci gaba da aiki tare da Majalisa akan dokoki don kafa tsarin tsarin zamani na duk gwaje-gwaje, gami da LDTs.

Yawancin dakunan gwaje-gwaje da ke ba da waɗannan gwaje-gwajen suna tallata gwaje-gwajen su a matsayin "masu ƙarfi" da "madaidaici," suna ba da "kwantar da hankali" ga marasa lafiya. FDA ta damu da cewa ƙila ba za a tallafa wa waɗannan da'awar tare da ingantacciyar shaidar kimiyya ba. Duk da yake waɗannan dakunan gwaje-gwajen suna da'awar gwajin nasu daidai ne, akwai iyakoki saboda ƙarancin wasu sharuɗɗan da aka haɗa a cikin tantancewar. Misali, lokacin da ake yin gwaji don yanayin da ba kasafai ba, sakamako mai kyau na iya zama mai yuwuwar zama tabbataccen ƙarya fiye da tabbataccen gaskiya, kuma mai yiwuwa ba za a iya shafan tayin a zahiri ba. A wasu lokuta, sakamako mai kyau na nunawa zai iya gano ainihin rashin lafiyar chromosomal, amma rashin lafiyar yana cikin mahaifa kuma ba cikin tayin ba, wanda zai iya zama lafiya.

Marasa lafiya da ma'aikatan kiwon lafiya ya kamata su san haɗari da iyakokin yin amfani da waɗannan gwaje-gwajen tantancewar mahaifa da kuma cewa bai kamata a yi amfani da su kaɗai ba don gano abubuwan da ba su da kyau na chromosomal (kwayoyin halitta). Koyaya, FDA tana sane da rahotannin cewa marasa lafiya da masu ba da kiwon lafiya sun yanke shawarar kula da lafiya mai mahimmanci dangane da sakamakon waɗannan gwaje-gwajen nunin ba tare da ƙarin gwajin tabbatarwa ba. Masu juna biyu sun kawo karshen masu juna biyu bisa sakamakon binciken kwayoyin halittar da aka yi mata kafin haihuwa kadai, ba tare da fahimtar iyakokin gwaje-gwajen da aka yi ba kuma mai yiwuwa tayin ba shi da wata matsala ta kwayoyin halittar da aka gano ta hanyar gwajin gwajin. 

FDA ta ba da shawarar cewa marasa lafiya da ma'aikatan kiwon lafiya su tattauna fa'idodi da kasada na duk gwajin kwayoyin halittar haihuwa, gami da gwaje-gwajen NIPS, tare da mai ba da shawara kan kwayoyin halitta ko wasu masu ba da lafiya kafin yin la'akari da irin wannan gwajin ko yin kowane yanke shawara game da ciki. Da fatan za a duba sadarwar aminci da ke da alaƙa a ƙasa don cikakken jerin shawarwarin marasa lafiya da masu ba da lafiya.

FDA za ta ci gaba da sa ido sosai kan batutuwan aminci game da amfani da gwaje-gwajen NIPS kuma ta himmatu wajen kare lafiyar jama'a.