Sabuwar tsarin kulawa mai rahusa wanda aka yi da takarda mai aiki da hanta
TAƘAITACCEN BAYANI
A matsayin ɗaya daga cikin mahimman hanyoyin kimanta yawan raunin hanta, na'urar nazarin halittu hanya ce ta gwaji ta al'ada. Duk da haka, ba a yi amfani da ita sosai a ƙasashe masu ƙarancin kuɗi (LMICs) ba saboda ƙarancin ma'aikata, rashin kuɗi da matsalolin muhalli masu rikitarwa. Yadda ake samun bayanai game da raunin hanta cikin sauri tare da hanya mai sauƙi da inganci wacce ke ba da tallafi mai ƙarfi ga yanke shawara na asibiti har yanzu ƙalubale ne ga LMICs. Don magance wannan matsalar, mun tsara sabon tsarin kulawa mai sauƙin amfani don raunin hanta. Wannan tsarin ya ƙunshi na'urar ganowa wacce ta dogara ne akan firikwensin photochemical macro biyu da katin gwaji na takarda tare da tsarin da aka gina don tace ƙwayoyin jini. Ana amfani da tsarin photon biyu don rage yawan da farashin tsarin gabaɗaya, yana rama kurakuran da aka gabatar a lokacin tsarin haɗa kayan aiki. Tsarin tace ƙwayoyin jini yana rage sarkakiyar aiki, kuma ana iya tace jinin, amsawa da canza launi kai tsaye akan katin gwaji. Na'urar ganowa tana samun siginar haske mai ci gaba na katin gwaji na takarda kuma tana ƙididdige siginar don kammala gwajin adadi na ma'aunin lalacewar hanta. Mun kwaikwayi yanayin ƙasa na LMICs don tantance aikin tsarin: a ƙarƙashin yanayin zafi na 35℃ da 90% na dangi, 40 Heparin jini gaba ɗaya, haɗin R2 Tsakanin tsarinmu da MindrayBS350s ya fi 0.95. Duka Randox Quality Control matakin 2 da matakin 3 CV maimaituwa sun kasance ƙasa da 7.5%. Sakamakon ya nuna cewa tsarin ba wai kawai ƙarami ne a girma ba, ƙarancin farashi kuma mai sauƙin aiki, aikin aunawa da kwanciyar hankali sun cika buƙatun asibiti na yanayin zafi mai yawa da zafi mai yawa, don haka ana iya amfani da shi a cikin LMICs don tantance aikin hanta na farko da kimanta ci gaban cututtukan hanta.
Kalmomi Masu Mahimmanci: Tsarin tunani; Na'urar firikwensin hoto; Sarrafa sigina da yawa; Gano raunin hanta cikin sauri; na'urar nazarin POCT; LMICs
1. GABATARWA
Cututtukan hanta sun zama babban nauyi ga lafiyar jama'a a duniya ta hanyar kashe mutane sama da miliyan 2 a duk duniya kowace shekara1,2Ana iya magance mafi yawan mace-macen (kamar ciwon hanta na kullum B), a warkar da su (kamar ciwon hanta na kullum C) ko a hana su (kamar gazawar hanta da miyagun ƙwayoyi ke haifarwa) idan aka gano su da kuma magance su cikin lokaci.3A halin yanzu ana gudanar da binciken cututtukan hanta ta hanyar amfani da hanyoyin da ba sa yin illa ga hanta, ciki har da na'urar daukar hoton ultrasound da hoton roba nan take, da kuma auna alamomin sinadarai a cikin jini. Duk da haka, waɗannan dabarun ganewar asali suna buƙatar kayan aiki masu inganci tare da ma'aikata masu ƙwarewa sosai, waɗanda galibi ba sa samuwa a ƙasashe masu ƙarancin kuɗi (LMICs) waɗanda ke da ƙarancin albarkatu waɗanda ke sa ganowa, ganowa da sa ido kan raunin hanta ya zama da wahala.4-7Sakamakon da ya biyo baya na iya zama cewa mutane da yawa ba a gano su ba har sai sun kai ga matakin ci gaba na cututtukan da ke haifar da jinkiri sosai a yanke shawara a asibiti da kuma tsadar magani mai yawa. Masana da yawa sun fahimci matsalar gano cututtukan hanta a cikin LMICs3, kuma sun nuna buƙatar gaggawa ta samar da wata hanya mai sauri, inganci da sauƙin ɗauka don auna raunin aikin hanta cikin sauri ga waɗannan ƙasashe.
*liyingchun@konsung.com;
Ana amfani da alamun Alamomin Alanine aminotransferase (ALT), aspartate aminotransferase (AST) da albumin (ALB) a asibiti wajen gano raunin hanta, ƙaruwar ɗaya daga cikinsu ko duka shine abin da ya fi faruwa a gwajin aikin hanta. Ana iya amfani da gano ALT, AST da ALB don yanke hukunci na farko game da raunin hanta da kuma kimanta ci gaban cututtukan hanta.8-13A halin yanzu akwai nau'ikan na'urorin sinadarai guda biyu da FDA ta amince da su don aikin hanta waɗanda galibi ake amfani da su a cikin LMICs: LDXH (Alere, San Diego, CA) da Roche ReflotronH Plus (Roche Diagnostics, Indianapolis, IN). Waɗannan nau'ikan na'urori guda biyu na iya yin ma'aunin ALT, AST akan jinin yatsa ba tare da buƙatar raba sinadarin jini ba. Duk da haka, ga LMICs masu ƙarancin albarkatu, yana da tsada sosai (kayan aiki dala 3000-6000 na Amurka, kayan gwaji sama da dala 4 na Amurka)14 da kuma hadaddun amfani, wanda ke buƙatar ƙwararrun ma'aikata masu ƙwarewa, ingantaccen samar da wutar lantarki, da kuma alamar alama ɗaya kawai da aka gwada a lokaci guda.
Mun ƙirƙiro wani dandamali mai sauri na gano ALT, AST da ALB bisa ga hoton haske, wanda ya dace da yanayin LMICs tare da fa'idodi masu yawa na ƙarancin farashi, sauƙin aiki, ikon gudanar da gwaje-gwajen jini gaba ɗaya/yatsu da kuma 'yancin samar da wutar lantarki ta dakin gwaje-gwaje. Tsarin gwaji ne na Gwajin Kulawa (POCT) mai ɗaukuwa wanda ya haɗa da mai nazarin POCT da katin gwaji mai dacewa da takarda. Ta amfani da wannan tsarin, za a iya fitar da jinin da za a auna zuwa wani yanki na musamman, kuma a hankali za a kammala tace ƙwayar jinin, sannan za a sami amsawar da ke da alaƙa da enzyme da kuma nuna launi. A ƙarshe, ana ƙididdige lanƙwasa mai haske na katin gwaji bisa takarda da na'urar POCT ta samu sannan a ƙididdige yawan ALT, AST da ALB. Babban fa'idodin da ke tattare da ƙarancin farashi, sauƙin ɗaukar na'urar tare da wurin gwaji mara iyaka da saurin gudu zai taimaka wajen faɗaɗa da kuma rarraba ayyukan tantancewa, kimantawa da kuma kula da cututtukan hanta a ƙasashe masu ƙarancin kuɗi, kuma wannan tsarin zai samar da tallafi mai ƙarfi ga manyan gwaje-gwaje a ƙasashe masu ƙarancin kuɗi tare da ƙarancin albarkatun tattalin arziki.
2. HANYOYI
2.1 Ka'idoji
Wannan tsarin ya dogara ne akan ka'idar Kubelka-Munk (ka'idar KM). Ana amfani da ka'idar KM gabaɗaya don nazarin spectra mai haske da aka samo daga samfuran da ke shan ruwa mai rauni wanda ke ba da alaƙa tsakanin haske da maida hankali. Ana iya tantance yawan nau'in sha ta amfani da dabarar Kubelka Munk:

Inda R = haske, k = ma'aunin sha, s = ma'aunin watsawa, c = yawan nau'in sha da A = sha15.
Jinin zai yi aiki a yankin gwaji na katin gwaji na tsarin da aka yi da takarda wanda ke haifar da canjin launi, kuma matakin canjin yana daidai da yawan da ke da alaƙa. A cewar ka'idar KM, ga jerin tsarin gwaji na kayan aiki iri ɗaya da kauri, wanda tushen haske iri ɗaya ya haskaka, k zai yi daidai da yawan sinadarin c, F(R) daidai da c, sannan za a iya ƙididdige yawan nau'in sha ta hanyar ƙimar haske.
2.2 Gwaje-gwajen aikin hanta bisa takarda
Katunan gwaji na takarda an yi su ne da yadudduka da yawa na takarda mai tsari (Hoto na 1), kowane layi tare da ayyuka da kayan aiki daban-daban. Ana haɗa layukan takarda da yawa a tsaye/ana sanya su a tsaye ta hanyar kayan polymeric don samar da katin gwajin reagent. Layer na sama yana amfani da gauze mai isotropic hydrophilic don samar da hanyar microfluidic hydrophilic da ke jagorantar jini zuwa yankin ganowa da aka keɓe don rabuwa da gwaji na plasma. Akwai yankuna huɗu masu zaman kansu a cikin katin gwaji, uku daga cikinsu yankunan gwaji ne, waɗanda za su iya auna ALT, AST da ALB bi da bi; wanda ya rage yanki ne na gano keɓancewa don tabbatar da aikin na'urar na yau da kullun. Kowanne daga cikin yankuna huɗu yana da yanayi na musamman (kamar reagents, buffers, alamomi) don tabbatar da cewa tsarin aunawa yana da sauri kuma ba shi da alaƙa da juna. Ta amfani da wannan tsarin, jimlar lokaci daga ƙarin samfurin zuwa kammala amsawa bai wuce minti 3 ba. Ma'aunin ALT da AST ya dogara ne akan hanyar peroxidase16, da kuma ALB bisa ga hanyar kore ta bromocresol17Mai nazarin yana auna yawan sinadarin da za a auna ta hanyar kama canjin launi na katin gwaji18,19.

Hoto na 1. Tsarin katin gwaji mai takarda (wanda ke hagu), da kuma canjin launi na katunan gwaji na ALB, AST, ALT bi da bi bayan mintuna 3 bayan ƙara samfurin
2.3 Tsarin gwajin aikin hanta mai rahusa
Ana amfani da na'urar POCT don ɗaukar canje-canjen launi na katunan gwaji na takarda kuma yana canza su zuwa fitarwa mai yawa. Na'urar ta haɗa da tsarin ɗaukar samfuri, tsarin gano haske na lantarki, tsarin nazarin sigina, tsarin wutar lantarki da tsarin nuni, kuma kowane tsarin an tsara shi daban-daban don sauƙin kulawa. Ana amfani da tsarin samfurin don gyara katin gwaji, kuma tsarin daukar hoto shine don samun bayanai daban-daban da kuma canza bayanan gani zuwa siginar lantarki. Bayan saka katin gwaji na takarda a cikin tsarin samfurin, za a ƙara digowar jini. Jinin yana shiga katin gwaji na takarda, yana wucewa ta hanyar rabuwar jini da ƙwanƙwasa jini da kuma amsawar sinadarai, sannan canje-canjen launi da aka samar ana kama su ta hanyar tsarin gano haske na na'urar POCT. Ta hanyar samfurin canza sigina zuwa maida hankali na tsarin nazarin sigina, ana samun yawan ALT, AST da ALB kuma a ƙarshe ana nuna su ta tsarin nuni.
Ga na'urar gano hasken lantarki, zuciyar na'urar POCT, mun tsara musamman na'urar firikwensin hasken haske mai tashoshi 4 mai ƙananan-photon biyu-mai haske mai haske wanda girmansa ya kai tsabar kuɗi kawai. Kowace tasha ta ƙunshi tushen haske guda 2 masu tsawon tsayi daban-daban, tushen haske guda 2 masu tsawon tsayi iri ɗaya da na'urar firikwensin mai karɓar haske 1, kamar yadda aka nuna a Hoto na 2. Ba kamar kayan aikin sinadarai na gargajiya ba, ƙirar na'urar firikwensin hasken haske mai ƙananan-ƙarfi a nan don ƙarancin amfani da wutar lantarki kuma tare da samar da wutar lantarki ta batirin lithium, za ta kasance ba tare da dogaro da wutar lantarki na al'ada ba. Kuma ta haka, an inganta ɗaukar na'urar da amfaninta. Bayan an sarrafa hasken da tushen haske mai ɓangarori biyu ke fitarwa ta hanyar ruwan tabarau, yana haskaka saman abin da za a auna. Ana tattara hasken da ke haskaka abin da ke ciki ta hanyar firikwensin bayan an sarrafa shi ta hanyar ruwan tabarau, sannan a canza shi zuwa siginar lantarki, kuma a yi rikodin shi azaman aikin tsawon tsayi. A wannan lokacin, abin da na'urar firikwensin ke karɓa shine haɗuwa da sigina daga tushen haske a ƙarshen hagu da dama, kuma siginar da ke nunawa tana ƙaruwa. Domin an riga an tsara nisan da ke tsakanin tushen haske guda biyu ta yadda siginar da aka nuna masu dacewa za su kasance masu dacewa. Ta wannan tsari, bambancin sigina tsakanin tashoshi daban-daban da kuskuren nisa ya haifar yayin haɗa kayan aikin za a iya rage shi zuwa mafi ƙanƙanta, don haka babu buƙatar daidaita tsakanin kayan aiki daban-daban don rage farashin samarwa, kuma a lokaci guda kula da kayan aikin bayan barin masana'anta zai zama mafi sauƙi da sauƙi.

Hoto na 2. Tsarin gano hasken lantarki da kuma zane-zanen firikwensin macro photochemical na tashoshi ɗaya mai tashoshi biyu.
2.4 Tsarin nazari
Domin tabbatar da yuwuwar wannan kayan aiki a cikin LMICs, mun gwada daidaiton ma'aunin jini gaba ɗaya da kuma sake maimaita Randox Quality Control a ƙarƙashin yanayin zafi na 90% a 35°C. An tattara dukkan samfuran jini, heparin sodium full blood, a watan Mayu na 2023 a asibiti na uku na mutane da ke Zhenjiang. An raba samfuran zuwa kwafi biyu, an saka centrifuge ɗaya sannan aka gwada shi a kan injin MindrayBS350s (Mindray, Shenzhen, China) a yanayin zafi na al'ada, ɗayan kuma an gwada shi da tsarin POCT da aka gabatar a cikin wannan takarda a 90% danshin dangi a 35°C kuma an rubuta sakamakon. A nan, an gwada Randox Quality Control (Randox, Northern Ireland, UK) mataki na 2 (Lot 1503UN) da mataki na 3 (Lot 1223UN) a 35°C da 90% danshin dangi tare da mai nazarin POCT da katunan gwaji sau 10 bi da bi.
2.5 Nazarin ƙididdiga
An yi nazarin bayanai da kuma samar da taswirar komawa baya ta amfani da Excel2013. An zana taswirar komawa baya da kuma ma'aunin haɗin gwiwa R2 An ƙididdige bambance-bambancen da aka lura a cikin sakamakon da ke tsakanin tsarin wannan binciken da MindrayBS350s, an ƙididdige Coefficient of variation (CV) don kimanta aikin aunawa.
3. SAKAMAKO
3.1 Yanayin aiki da aikin gwaji
A cikin shari'o'i 40 na jinin heparin, alaƙar, R2, na ALT, AST da ALB tare da MindrayBS350s shine 0.9909, 0.9918, da 0.9913 bi da bi a 35°C da 90% danshin da ke da alaƙa, kamar yadda aka nuna a Hoto na 3. R2 na abubuwa uku duk sun fi 0.95 girma, kuma ya nuna cewa sakamakon na'urar da abubuwan da ke tallafawa suna da kyakkyawar alaƙa da na'urar kimiyyar sinadarai ta MindrayBS350s a cikin wannan yanayi.

Hoto na 3. Alaƙa da MindrayBS350s don cikakken ALT, AST da ALB a cikin 35°C da 90% na ɗanɗano.
3.2 Daidaito
Daidaiton da aka yi a cikin rukuni yana nuna kuskuren aunawa a cikin rukuni, wanda kuma aka sani da maimaitawa, ana tantance shi akai-akai ta hanyar mai aiki ɗaya akan samfurin iri ɗaya. A 35°C da 90% na ɗanɗano, ana kimanta daidaiton kayan aiki da katunan gwaji ta amfani da kulawar ingancin Randox don tabbatar da cewa muhalli yana haifar da kurakurai marasa iyaka. An nuna sakamakon a cikin tebur na 1, kula da ingancin Randox ALT Level 2 CV shine 5.8%, Level 3 4.5%; AST Level 2 CV 6.5% da Level 3 CV 2.5%. ALB Level 2 shine 5.7%, Level 3 7.3%. ALT da AST sun yi daidai da ma'aunin masana'antar busassun sinadarai na China.20: ma'aunin bambancin ALT da AST a cikin kewayon maida hankali na 40U/L ~ 60U/L ƙasa da ko daidai yake da 12%, da kuma CV tare da kewayon maida hankali na 100U/L ~ 300U/L ƙasa da ko daidai yake da 5%; Duk masu nazarin da ke sama sun cika buƙatun cewa CV ƙasa da 7.5% da aka jera a cikin littafin jagorar yawancin masu nazarin POCT masu busassun sinadarai waɗanda aka riga aka sayar a kasuwa. Sakamakon ya nuna cewa a ƙarƙashin yanayin zafi na 35°C da 90% na ɗanɗano, CV na kayan aiki da katin gwaji suna cikin kewayon da aka yarda da shi, kuma kuskuren bazuwar katin gwaji a ƙarƙashin irin wannan yanayi ya zama abin karɓa.
Tebur1 Gwajin sarrafa inganci na ALT, AST da ALB Randox da sakamakon.
| A'a. | KOMAI(U/L) | AST(U/L) | FARAR (g/L) | |||
| Mataki na 2 | Mataki na 3 | Mataki na 2 | Mataki na 3 | Mataki na 2 | Mataki na 3 | |
| 1 | 38 | 164 | 46 | 200 | 41.9 | 28.3 |
| 2 | 37 | 148 | 51 | 205 | 37.6 | 33.3 |
| 3 | 36 | 155 | 52 | 198 | 41.6 | 30.0 |
| 4 | 35 | 146 | 59 | 201 | 39.8 | 32.3 |
| 5 | 42 | 148 | 53 | 187 | 44.4 | 26.8 |
| 6 | 37 | 143 | 51 | 196 | 41.2 | 32.3 |
| 7 | 36 | 155 | 55 | 197 | 43.2 | 31.3 |
| 8 | 38 | 148 | 53 | 203 | 45.6 | 33.7 |
| 9 | 38 | 141 | 56 | 199 | 40.9 | 32.4 |
| 10 | 41 | 149 | 53 | 202 | 44.5 | 33.1 |
| Matsakaicin SD CV(SD/Matsakaicin) | 37.8 2.2 5.8% | 149.7 6.7 4.5% | 52.9 3.4 6.5% | 198.8 5.0 2.5% | 42.1 2.4 5.7% | 31.4 2.3 7.3% |
4. TATTAUNAWA DA KAMMALAWA
An yi amfani da na'urorin nazarin halittu a matsayin hanyar da aka fi so don gano alamun hanta kamar ALT, AST, da ALB tsawon shekaru da yawa. Bayan an tattara jinin jijiyoyin jini na ɗan adam, ana jigilar shi zuwa dakin gwaje-gwaje na tsakiya, inda ƙwararrun ma'aikata ke raba sinadarin jini kuma ana gwada shi ta hanyar na'urar nazarin halittu. Waɗannan hanyoyin gano abubuwa na yau da kullun suna da matuƙar wahala ga LMICs saboda: kayan aiki masu tsada, yanayin gwaji mai ɗorewa da ake buƙata, da ƙwararrun ma'aikata don yin gwaje-gwajen da kuma kulawa mai mahimmanci. Bugu da ƙari, duk da cewa ana iya gudanar da ganowa, yanayin da LMICs ke warwatse zai jinkirta sakamakon ganowa.
A cikin wannan takarda, an tsara tsarin da ke da saurin gano raunin hanta mai rahusa da sauri. Idan aka kwatanta da na'urorin POC da ake da su da kuma nazarin da aka buga a baya. 21, 22, 23Na'urorinmu na POCT za su iya yin gwaje-gwajen adadi na ALT, AST da ALB a lokaci guda. Tsarin ƙarancin amfani da wutar lantarki da batirin lithium yana sa a iya yin gwaje-gwajen da suka shafi kowane lokaci da kuma ko'ina ba tare da la'akari da samar da wutar lantarki na wurin gwajin ba. Saboda ana iya gwada jinin gefe kai tsaye, babu buƙatar tsarin centrifugation mai rikitarwa kafin gwaji. Kuma manyan masu tsabtace jiki bayan horo mai sauƙi za su iya yin gwajin da kyau. Kudin shine 0.95 bi da bi, kuma sake maimaita ingancin kula da Randox duk sun faɗi ƙasa da 7.5% daidai da ma'aunin masana'antar masu nazarin sinadarai na busassun na China, CV na ALT da AST a cikin kewayon taro na 40U/L ~ 60U/L ƙasa da ko daidai da 12%, da CV tare da kewayon taro na 100U/L ~ 300U/L ƙasa da ko daidai da 5%, wanda ya cika buƙatun cewa CV ƙasa da 7.5% da aka jera a cikin littafin jagorar yawancin masu nazarin sinadarai na busassun POCT waɗanda ke kan kasuwa. Ana iya amfani da wannan na'urar da katin gwaji na takarda a cikin LMICs don biyan buƙatun alamun raunin hanta cikin sauri.
A taƙaice, na'urar nazarin POCT da kayan aikin da ke tallafawa ko katin gwaji da aka gabatar a cikin wannan takarda suna da fa'idodi masu zuwa:
1. Ana iya amfani da ma'aikatan kiwon lafiya na farko tare da horo mai sauƙi; 2. Tsarin da aka yi da takarda yana da sauƙin sarrafawa da kiyayewa; 3. Ana iya gwada gwaje-gwajen adadi guda uku, ALT, AST da ALB, a lokaci guda, lokacin gwajin yana cikin mintuna 3, da kuma ƙarar jini
GODIYA
Gidauniyar Bincike ta Sabbin Sabbin Bincike (FIND) ce ta dauki nauyin nazarin yanayin aiki da kuma aikin gwaji a cikin wannan takarda.
NAZARI
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